TriangleNCT02349412 · OUTCOME
Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to 12 weeks
What was measured
Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Higher scores on FACT-G indicate better QOL.
Analysis population: Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.
Groups in this outcome
Arm 1 (Early Palliative Care)
Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.
Arm 2 (Usual Care)
Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
| Group | Source count |
|---|---|
| Arm 1 (Early Palliative Care) | 92 |
| Arm 2 (Usual Care) | 101 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1 (Early Palliative Care) | 3.35 | 14.7 | Not reported | Not reported | Not reported |
| Arm 2 (Usual Care) | 0.12 | 12.7 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.13
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.104
- param Type
- Mean Difference (Final Values)
- param Value
- 3.23
- statistical Comment
- Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -0.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.13
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.104
- param Type
- Mean Difference (Final Values)
- param Value
- 3.23
- statistical Comment
- Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 14.7
- value
- 3.35
- group Id
- OG001
- spread
- 12.7
- value
- 0.12
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 101
- units
- Participants
- description
- Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Higher scores on FACT-G indicate better QOL.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.
- id
- OG000
- title
- Arm 1 (Early Palliative Care)
- description
- Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
- id
- OG001
- title
- Arm 2 (Usual Care)
- param Type
- MEAN
- population Description
- Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Up to 12 weeks
- title
- Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G)
- type
- PRIMARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice