TriangleNCT02489422 · STUDY IN CONTEXT
Programs To Support You During Chemotherapy
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.
Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.
Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.
Circadian disruption will be assessed with measures of activity and rest. Activity will be measured using the 3-item Godin's leisure score index (LSI), previously used with colorectal cancer patients during chemotherapy. Rest will be assessed with the 8-item PROMIS sleep disturbance short-form. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Will be assessed with the standardized 10-item PROMIS-cancer depressive symptoms short-form. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive the symptoms. Scores on the short form range from 10 to 81.3; 10-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
Fatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue.
Reported safety
Quality of life and patient-reported measures
PROMIS · Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0000
- source section id
- NCT02489422-om-0000
- source outcome index
- 0
- instrument
- PROMIS
- instrument basis
- matched 'promis' in the study's own wording
- scale title
- Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
- measure definition
- Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.
- time frame
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- primary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
PROMIS · Circadian Disruption (Recalled)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0003
- source section id
- NCT02489422-om-0003
- source outcome index
- 3
- instrument
- PROMIS
- instrument basis
- matched 'promis' in the study's own wording
- scale title
- Circadian Disruption (Recalled)
- measure definition
- Circadian disruption will be assessed with measures of activity and rest. Activity will be measured using the 3-item Godin's leisure score index (LSI), previously used with colorectal cancer patients during chemotherapy. Rest will be assessed with the 8-item PROMIS sleep disturbance short-form. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
- time frame
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
PROMIS · Depressive Symptoms Assessed by PROMIS
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0004
- source section id
- NCT02489422-om-0004
- source outcome index
- 4
- instrument
- PROMIS
- instrument basis
- matched 'promis' in the study's own wording
- scale title
- Depressive Symptoms Assessed by PROMIS
- measure definition
- Will be assessed with the standardized 10-item PROMIS-cancer depressive symptoms short-form. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive the symptoms. Scores on the short form range from 10 to 81.3; 10-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
- time frame
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
PROMIS · Fatigue (Daily)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0005
- source section id
- NCT02489422-om-0005
- source outcome index
- 5
- instrument
- PROMIS
- instrument basis
- matched 'promis' in the study's own wording
- scale title
- Fatigue (Daily)
- measure definition
- Fatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue.
- time frame
- At 0-2 weeks and 8-10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
PROMIS · Depressive Symptoms (Daily)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0006
- source section id
- NCT02489422-om-0006
- source outcome index
- 6
- instrument
- PROMIS
- instrument basis
- matched 'promis' in the study's own wording
- scale title
- Depressive Symptoms (Daily)
- measure definition
- Depressive symptoms will be assessed with 3 items selected from the PROMIS measure of depression validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive symptoms the participants exhibited. scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
- time frame
- At 0-2 weeks and 8-10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0007
- source section id
- NCT02489422-om-0007
- source outcome index
- 7
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
- time frame
- At 2 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0008
- source section id
- NCT02489422-om-0008
- source outcome index
- 8
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. ). All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
- time frame
- At 10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0009
- source section id
- NCT02489422-om-0009
- source outcome index
- 9
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
- time frame
- At 2 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0010
- source section id
- NCT02489422-om-0010
- source outcome index
- 10
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
- time frame
- At 10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0011
- source section id
- NCT02489422-om-0011
- source outcome index
- 11
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
- time frame
- At 2 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0012
- source section id
- NCT02489422-om-0012
- source outcome index
- 12
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
- time frame
- At 10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Psychological Stress Assessed by the Perceived Stress Scale (PSS)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0013
- source section id
- NCT02489422-om-0013
- source outcome index
- 13
- instrument
- FACT
- instrument basis
- matched 'factors' in the study's own wording
- scale title
- Psychological Stress Assessed by the Perceived Stress Scale (PSS)
- measure definition
- Psychological stress will be assessed by the 10-item PSS. The PSS has 2 factors (stress and counter stress). Scoring scale range from 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often and 4 - very often. Score range is 0-40. A higher score represents more of the concept being measured.
- time frame
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Psychological Stress Assessed by the PSS (Daily)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0014
- source section id
- NCT02489422-om-0014
- source outcome index
- 14
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Psychological Stress Assessed by the PSS (Daily)
- measure definition
- Psychological stress will be assessed daily with two items from the 4-item PSS that would be on the same factor to optimize internal consistency. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. A mean of the participants scores was taken.
- time frame
- At 0-2 weeks and 8-10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0016
- source section id
- NCT02489422-om-0016
- source outcome index
- 16
- instrument
- FACT
- instrument basis
- matched 'factors' in the study's own wording
- scale title
- Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
- measure definition
- Regulation of psychological stress will be determined by ratings on four of the seven factors of the Cancer Behavior Inventory, which assess self-efficacy for stress management, coping with treatment-related side-effects, accepting cancer/maintaining positive attitude, and affective regulation. Scale ranged from 1-9 (1 - 3 not at all confident; 4-6 moderately confident and 7-9 totally confident). 4 of the 7 items from the Cancer Behavior Inventory (V2.0) were used with each item's score ranges from 0-50 with higher scores indicating more confidence in the item.
- time frame
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- trial label
- Programs To Support You During Chemotherapy
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 14
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0000
- source section id
- NCT02489422-om-0000
- source outcome index
- 0
- endpoint
- Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
- endpoint definition
- Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.
- time origin
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0001
- source section id
- NCT02489422-om-0001
- source outcome index
- 1
- endpoint
- Circadian Disruption (Daily)
- endpoint definition
- Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.
- time origin
- At 0-2 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants analyzed represents the number of participants that completed the analysis and had data for this outcome measure out of the total number of participants for the trial.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0002
- source section id
- NCT02489422-om-0002
- source outcome index
- 2
- endpoint
- Circadian Disruption (Daily)
- endpoint definition
- Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.
- time origin
- At 8-10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The number of participants is the actual number that completed this portion of the outcome measure during this timeframe that had measurable data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0003
- source section id
- NCT02489422-om-0003
- source outcome index
- 3
- endpoint
- Circadian Disruption (Recalled)
- endpoint definition
- Circadian disruption will be assessed with measures of activity and rest. Activity will be measured using the 3-item Godin's leisure score index (LSI), previously used with colorectal cancer patients during chemotherapy. Rest will be assessed with the 8-item PROMIS sleep disturbance short-form. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
- time origin
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0004
- source section id
- NCT02489422-om-0004
- source outcome index
- 4
- endpoint
- Depressive Symptoms Assessed by PROMIS
- endpoint definition
- Will be assessed with the standardized 10-item PROMIS-cancer depressive symptoms short-form. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive the symptoms. Scores on the short form range from 10 to 81.3; 10-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
- time origin
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0005
- source section id
- NCT02489422-om-0005
- source outcome index
- 5
- endpoint
- Fatigue (Daily)
- endpoint definition
- Fatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue.
- time origin
- At 0-2 weeks and 8-10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Group I (Yoga Skills Training)
- regimen
- Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Group II (Attention Control)
- regimen
- Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Group I (Yoga Skills Training)
- regimen
- Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Group II (Attention Control)
- regimen
- Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Group I (Yoga Skills Training)
- regimen
- Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Group II (Attention Control)
- regimen
- Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Group I (Yoga Skills Training)
- regimen
- Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Group II (Attention Control)
- regimen
- Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Group I (Yoga Skills Training)
- regimen
- Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Group II (Attention Control)
- regimen
- Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Group I (Yoga Skills Training)
- regimen
- Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Group II (Attention Control)
- regimen
- Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489422-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- harm key
- EG000
- source section id
- NCT02489422-ae
- event group key
- EG000
- event group label
- Group I (Yoga Skills Training)
- serious affected
- 4
- serious at risk
- 23
- other affected
- 1
- other at risk
- 23
- frequency threshold
- 0
- collection period
- Over 8 weeks
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- harm key
- EG001
- source section id
- NCT02489422-ae
- event group key
- EG001
- event group label
- Group II (Attention Control)
- serious affected
- 3
- serious at risk
- 21
- other affected
- 2
- other at risk
- 21
- frequency threshold
- 0
- collection period
- Over 8 weeks
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0000
- source section id
- NCT02489422-om-0000
- source outcome index
- 0
- instrument
- PROMIS
- instrument basis
- matched 'promis' in the study's own wording
- scale title
- Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
- measure definition
- Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.
- time frame
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- primary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0003
- source section id
- NCT02489422-om-0003
- source outcome index
- 3
- instrument
- PROMIS
- instrument basis
- matched 'promis' in the study's own wording
- scale title
- Circadian Disruption (Recalled)
- measure definition
- Circadian disruption will be assessed with measures of activity and rest. Activity will be measured using the 3-item Godin's leisure score index (LSI), previously used with colorectal cancer patients during chemotherapy. Rest will be assessed with the 8-item PROMIS sleep disturbance short-form. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
- time frame
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0004
- source section id
- NCT02489422-om-0004
- source outcome index
- 4
- instrument
- PROMIS
- instrument basis
- matched 'promis' in the study's own wording
- scale title
- Depressive Symptoms Assessed by PROMIS
- measure definition
- Will be assessed with the standardized 10-item PROMIS-cancer depressive symptoms short-form. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive the symptoms. Scores on the short form range from 10 to 81.3; 10-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
- time frame
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0005
- source section id
- NCT02489422-om-0005
- source outcome index
- 5
- instrument
- PROMIS
- instrument basis
- matched 'promis' in the study's own wording
- scale title
- Fatigue (Daily)
- measure definition
- Fatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue.
- time frame
- At 0-2 weeks and 8-10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0006
- source section id
- NCT02489422-om-0006
- source outcome index
- 6
- instrument
- PROMIS
- instrument basis
- matched 'promis' in the study's own wording
- scale title
- Depressive Symptoms (Daily)
- measure definition
- Depressive symptoms will be assessed with 3 items selected from the PROMIS measure of depression validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive symptoms the participants exhibited. scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
- time frame
- At 0-2 weeks and 8-10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0007
- source section id
- NCT02489422-om-0007
- source outcome index
- 7
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
- time frame
- At 2 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0008
- source section id
- NCT02489422-om-0008
- source outcome index
- 8
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. ). All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
- time frame
- At 10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0009
- source section id
- NCT02489422-om-0009
- source outcome index
- 9
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
- time frame
- At 2 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0010
- source section id
- NCT02489422-om-0010
- source outcome index
- 10
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
- time frame
- At 10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0011
- source section id
- NCT02489422-om-0011
- source outcome index
- 11
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
- time frame
- At 2 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0012
- source section id
- NCT02489422-om-0012
- source outcome index
- 12
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
- measure definition
- Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
- time frame
- At 10 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Numbers may vary based on number of participants that actually completed intervention materials
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT02489422
- qol key
- qol-0013
- source section id
- NCT02489422-om-0013
- source outcome index
- 13
- instrument
- FACT
- instrument basis
- matched 'factors' in the study's own wording
- scale title
- Psychological Stress Assessed by the Perceived Stress Scale (PSS)
- measure definition
- Psychological stress will be assessed by the 10-item PSS. The PSS has 2 factors (stress and counter stress). Scoring scale range from 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often and 4 - very often. Score range is 0-40. A higher score represents more of the concept being measured.
- time frame
- At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice