NCT01401907 · STUDY IN CONTEXT
Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies
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
The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study
The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks.
The hospital anxiety and depression scale examines symptoms of depression and anxiety. We compared rates of clinically significant depression symptoms (using a cut off of 8 on the depression subscale score) between study arms at week-12 and week-24.
We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Participants reported their primary goal of their current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Participants' responses were dichotomized as 1) to cure my cancer vs. all other.
The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.
We used the Hospital Anxiety and Depression scale to measure overall psychological distress in family caregivers. The Hospital Anxiety and Depression Scale contains two subscales measuring depression and anxiety respectively. When examined continuously, this scale reflects degree of psychological distress with higher scores indicating more psychological distress (range 0-42). We compared overall psychological distress (HADS-total) among family caregivers between the two study arms
Reported safety
Quality of life and patient-reported measures
Unnamed quality-of-life measure · Functional Assessment of Cancer Therapy (Quality of Life Measure)
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- qol key
- qol-0000
- source section id
- NCT01401907-om-0000
- source outcome index
- 0
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy (Quality of Life Measure)
- measure definition
- The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study
- time frame
- 12 weeks
- analysis role
- primary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Functional Assessment of Cancer Therapy (Quality of Life Measure)
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- qol key
- qol-0001
- source section id
- NCT01401907-om-0001
- source outcome index
- 1
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy (Quality of Life Measure)
- measure definition
- The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks.
- time frame
- 24 weeks
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- The analysis focuses on participants who completed week-24 questionnaires (N = 118 in the early palliative care arm, and N = 124 in the standard of care arm)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
SF-36 / SF-12 · Family Caregiver Quality of Life as Measured by the SF-36
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- qol key
- qol-0004
- source section id
- NCT01401907-om-0004
- source outcome index
- 4
- instrument
- SF-36 / SF-12
- instrument basis
- matched 'sf-36' in the study's own wording
- scale title
- Family Caregiver Quality of Life as Measured by the SF-36
- measure definition
- The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.
- time frame
- Week-12 and Week-24
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher scores indicate better
- population note
- Adjusted Means controlling for baseline scores. The different rows reflect Week-12 and Week-24 outcomes on SF-36 PCS and MCS domains. The number of participants included in week-12 and week-24 analyses reflect the participants who completed the SF-36 at these time points, which explains the discrepancy with the flow chart.
- 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-liver-neoplasm
- nct id
- NCT01401907
- trial label
- Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies
- 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
- 3
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0000
- source section id
- NCT01401907-om-0000
- source outcome index
- 0
- endpoint
- Functional Assessment of Cancer Therapy (Quality of Life Measure)
- endpoint definition
- The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study
- time origin
- 12 weeks
- 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-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0001
- source section id
- NCT01401907-om-0001
- source outcome index
- 1
- endpoint
- Functional Assessment of Cancer Therapy (Quality of Life Measure)
- endpoint definition
- The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks.
- time origin
- 24 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis focuses on participants who completed week-24 questionnaires (N = 118 in the early palliative care arm, and N = 124 in the standard of care arm)
- 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-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0002
- source section id
- NCT01401907-om-0002
- source outcome index
- 2
- endpoint
- Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale
- endpoint definition
- The hospital anxiety and depression scale examines symptoms of depression and anxiety. We compared rates of clinically significant depression symptoms (using a cut off of 8 on the depression subscale score) between study arms at week-12 and week-24.
- time origin
- Week-12 and Week-24
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The two rows examine outcomes at two different time points week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart.
- 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-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0003
- source section id
- NCT01401907-om-0003
- source outcome index
- 3
- endpoint
- Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer
- endpoint definition
- We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Participants reported their primary goal of their current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Participants' responses were dichotomized as 1) to cure my cancer vs. all other.
- time origin
- Week12 and Week 24
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The different rows reflect analyses at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the Perception of Treatment and Prognosis Questionnaire at these time points (study completers), which explains the discrepancy with the flow chart.
- 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-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0004
- source section id
- NCT01401907-om-0004
- source outcome index
- 4
- endpoint
- Family Caregiver Quality of Life as Measured by the SF-36
- endpoint definition
- The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.
- time origin
- Week-12 and Week-24
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Adjusted Means controlling for baseline scores. The different rows reflect Week-12 and Week-24 outcomes on SF-36 PCS and MCS domains. The number of participants included in week-12 and week-24 analyses reflect the participants who completed the SF-36 at these time points, which explains the discrepancy with the flow chart.
- 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-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0005
- source section id
- NCT01401907-om-0005
- source outcome index
- 5
- endpoint
- Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)
- endpoint definition
- We used the Hospital Anxiety and Depression scale to measure overall psychological distress in family caregivers. The Hospital Anxiety and Depression Scale contains two subscales measuring depression and anxiety respectively. When examined continuously, this scale reflects degree of psychological distress with higher scores indicating more psychological distress (range 0-42). We compared overall psychological distress (HADS-total) among family caregivers between the two study arms
- time origin
- Week 12 and Week 24
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Looking at the HADS-total score at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart.
- 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-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Early Palliative Care
- regimen
- Subjects receive standard of care with early palliative care. early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care.
- analyzed count
- 148
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- Subjects receives standard of care
- analyzed count
- 153
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Early Palliative Care
- regimen
- Subjects receive standard of care with early palliative care. early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care.
- analyzed count
- 118
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- Subjects receives standard of care
- analyzed count
- 124
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Early Palliative Care
- regimen
- Early Palliative Care
- analyzed count
- 138
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Standard Oncology Care
- regimen
- Standard Oncology Care
- analyzed count
- 141
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Early Palliative Care
- regimen
- Early Palliative Care
- analyzed count
- 143
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Standard Oncology Care
- regimen
- Standard Oncology Care
- analyzed count
- 145
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Early Palliative Care
- regimen
- Early Palliative Care
- analyzed count
- 110
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Standard Oncology Care
- regimen
- Standard Oncology Care
- analyzed count
- 119
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Early Palliative Care
- regimen
- Early Palliative Care
- analyzed count
- 110
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Standard Oncology Care
- regimen
- Standard Oncology Care
- analyzed count
- 119
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01401907-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01401907
- harm key
- EG000
- source section id
- NCT01401907-ae
- event group key
- EG000
- event group label
- Early Palliative Care
- serious affected
- 0
- serious at risk
- 175
- other affected
- 0
- other at risk
- 175
- frequency threshold
- 5
- collection period
- 6 months
- event definition
- no AE from this non-medication/treatment study
- 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-liver-neoplasm
- nct id
- NCT01401907
- harm key
- EG001
- source section id
- NCT01401907-ae
- event group key
- EG001
- event group label
- Standard of Care
- serious affected
- 0
- serious at risk
- 175
- other affected
- 0
- other at risk
- 175
- frequency threshold
- 5
- collection period
- 6 months
- event definition
- no AE from this non-medication/treatment study
- 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-liver-neoplasm
- nct id
- NCT01401907
- qol key
- qol-0000
- source section id
- NCT01401907-om-0000
- source outcome index
- 0
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy (Quality of Life Measure)
- measure definition
- The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study
- time frame
- 12 weeks
- analysis role
- primary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- 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-liver-neoplasm
- nct id
- NCT01401907
- qol key
- qol-0001
- source section id
- NCT01401907-om-0001
- source outcome index
- 1
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy (Quality of Life Measure)
- measure definition
- The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks.
- time frame
- 24 weeks
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- The analysis focuses on participants who completed week-24 questionnaires (N = 118 in the early palliative care arm, and N = 124 in the standard of care arm)
- 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-liver-neoplasm
- nct id
- NCT01401907
- qol key
- qol-0004
- source section id
- NCT01401907-om-0004
- source outcome index
- 4
- instrument
- SF-36 / SF-12
- instrument basis
- matched 'sf-36' in the study's own wording
- scale title
- Family Caregiver Quality of Life as Measured by the SF-36
- measure definition
- The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.
- time frame
- Week-12 and Week-24
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher scores indicate better
- population note
- Adjusted Means controlling for baseline scores. The different rows reflect Week-12 and Week-24 outcomes on SF-36 PCS and MCS domains. The number of participants included in week-12 and week-24 analyses reflect the participants who completed the SF-36 at these time points, which explains the discrepancy with the flow chart.
- 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
Triangle