NCT02489422 · REGISTRY CONDITION SEARCH

Programs To Support You During Chemotherapy

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2022-10-14

This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)

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outcome · POSTED

Circadian Disruption (Daily)

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outcome · POSTED

Circadian Disruption (Daily)

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outcome · POSTED

Circadian Disruption (Recalled)

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outcome · POSTED

Depressive Symptoms Assessed by PROMIS

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outcome · POSTED

Fatigue (Daily)

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outcome · POSTED

Depressive Symptoms (Daily)

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outcome · POSTED

Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits

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outcome · POSTED

Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits

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outcome · POSTED

Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits

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outcome · POSTED

Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits

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outcome · POSTED

Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits

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outcome · POSTED

Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits

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outcome · POSTED

Psychological Stress Assessed by the Perceived Stress Scale (PSS)

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outcome · POSTED

Psychological Stress Assessed by the PSS (Daily)

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outcome · POSTED

Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily)

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outcome · POSTED

Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory

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outcome · POSTED

Minutes of Home Practice Completed

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outcome · POSTED

Percent of Planned In Person Intervention Sessions Attended

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outcome · POSTED

Number of Participants With Successful Qualitative Data Collection

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Scheduled to receive first-line Fluorouracil (5FU)-based intravenous chemotherapy treatment for a gastrointestinal cancer (stages II-IV) * Have an Eastern Cooperative Oncology Group performance status of =\< 1 * Ability to understand and the willingness to sign and informed consent document in English Exclusion Criteria: * Has a self-reported history of diagnosed uncontrolled obstructive sleep apnea (ok if using CPAP), sleep-related seizures, sleep walking more than one time per week, restless leg syndrome, or a job with night shifts
healthy Volunteers: false
minimum Age: 21 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
Other: Daily Survey Administration
Behavioral: Yoga Skills Training
Other: Actigraphy Assessment
label
Group I (Yoga Skills Training)
type
EXPERIMENTAL
description
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
intervention Names
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
Other: Daily Survey Administration
Behavioral: Attention Control
Other: Actigraphy Assessment
label
Group II (Attention Control)
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Group I (Yoga Skills Training)
Group II (Attention Control)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Group I (Yoga Skills Training)
Group II (Attention Control)
description
Ancillary studies
name
Questionnaire Administration
type
OTHER
arm Group Labels
Group I (Yoga Skills Training)
Group II (Attention Control)
description
Ancillary studies
name
Daily Survey Administration
type
OTHER
arm Group Labels
Group I (Yoga Skills Training)
description
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.
name
Yoga Skills Training
other Names
yoga
YST
type
BEHAVIORAL
arm Group Labels
Group II (Attention Control)
description
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.
name
Attention Control
other Names
empathic attention control
supportive conversation
caring attention control
type
BEHAVIORAL
arm Group Labels
Group I (Yoga Skills Training)
Group II (Attention Control)
description
Ancillary studies
name
Actigraphy Assessment
other Names
Circadian Disruption - daily
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 44
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
time Frame
At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

secondary Outcomes

description
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.
measure
Circadian Disruption (Daily)
time Frame
At 0-2 weeks after start of intervention
description
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.
measure
Circadian Disruption (Daily)
time Frame
At 8-10 weeks after start of intervention
description
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.
measure
Circadian Disruption (Recalled)
time Frame
At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
description
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.
measure
Depressive Symptoms Assessed by PROMIS
time Frame
At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
description
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.
measure
Fatigue (Daily)
time Frame
At 0-2 weeks and 8-10 weeks after start of intervention
description
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.
measure
Depressive Symptoms (Daily)
time Frame
At 0-2 weeks and 8-10 weeks after start of intervention
description
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.
measure
Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
time Frame
At 2 weeks after start of intervention
description
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.
measure
Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
time Frame
At 10 weeks after start of intervention
description
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.
measure
Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
time Frame
At 2 weeks after start of intervention
description
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.
measure
Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
time Frame
At 10 weeks after start of intervention
description
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.
measure
Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
time Frame
At 2 weeks after start of intervention
description
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.
measure
Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
time Frame
At 10 weeks after start of intervention

Full study description

brief Summary: This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.
detailed Description: PRIMARY OBJECTIVES: I. To conduct a pilot randomized controlled trial of the yoga skills training (YST) versus a caring attention control (AC) group among adults with colorectal cancer (CRC) receiving chemotherapy to determine preliminary efficacy for the primary outcome of fatigue, secondary outcome of depressive symptoms, and possible mediators (i.e., psychological stress, circadian disruption, inflammation) as assessed by standard measures. SECONDARY OBJECTIVES: I. To measure the impact of the YST versus the AC on daily assessments of fatigue, depressive symptoms, and proposed mediators in the same trial and explore relationships among daily and standard assessments. II. To qualitatively assess perceived efficacy of the YST and AC and acceptability of new methodology through semi-structured interviews in a subset of 20-40 participants. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (YST): 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. GROUP II (AC): Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, and 8. After completion of study, patients are followed up at 4 weeks.

Source references