Trial Outcomes & Findings for Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers (NCT NCT02349412)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

405 participants

Primary outcome timeframe

Up to 12 weeks

Results posted on

2025-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	202	203
Overall Study Completed Week-12 QOL Assessment Measure	92	101
Overall Study Completed Week-24 QOL Assessment Measure	68	80
Overall Study COMPLETED	195	196
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	7	7

Baseline Characteristics

Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 (Early Palliative Care) n=195 Participants 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) n=196 Participants 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.	Total n=391 Participants Total of all reporting groups
Age, Continuous	65.5 years n=5 Participants	65.0 years n=7 Participants	65.2 years n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	89 Participants n=7 Participants	170 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	107 Participants n=7 Participants	221 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) White	148 Participants n=5 Participants	155 Participants n=7 Participants	303 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	195 Participants n=5 Participants	196 Participants n=7 Participants	391 Participants n=5 Participants
ECOG Performance Status 0	47 Participants n=5 Participants	41 Participants n=7 Participants	88 Participants n=5 Participants
ECOG Performance Status 1	108 Participants n=5 Participants	127 Participants n=7 Participants	235 Participants n=5 Participants
ECOG Performance Status 2	40 Participants n=5 Participants	28 Participants n=7 Participants	68 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Arm 1 (Early Palliative Care) n=92 Participants 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) n=101 Participants 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.
Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G)	3.35 units on a scale Standard Deviation 14.7	0.12 units on a scale Standard Deviation 12.7

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Only participants with available data on the individual study measure at baseline and 24 weeks were included in the analysis.

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-24 was calculated by subtracting the baseline scores from the scores at week-24. Higher scores on FACT-G indicate better QOL.

Outcome measures

Outcome measures
Measure	Arm 1 (Early Palliative Care) n=68 Participants 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) n=80 Participants 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.
Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G)	3.80 units on a scale Standard Deviation 15.3	0.69 units on a scale Standard Deviation 13.3

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.

Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Depression on a 0-21 scale, with lower scores corresponding to lower depression and higher scores corresponding to higher depression. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Depression indicate less depression symptoms.

Outcome measures

Outcome measures
Measure	Arm 1 (Early Palliative Care) n=100 Participants 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) n=112 Participants 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.
Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression	0.54 units on a scale Standard Deviation 4.0	0.46 units on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.

Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Anxiety on a 0-21 scale, with lower scores corresponding to lower anxiety and higher scores corresponding to higher anxiety. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Anxiety indicate less anxiety symptoms.

Outcome measures

Outcome measures
Measure	Arm 1 (Early Palliative Care) n=100 Participants 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) n=111 Participants 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.
Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety	-1.13 units on a scale Standard Deviation 2.7	-0.32 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Only participants with available data on the individual study measure at week 12 were included in the analysis.

Prognostic Understanding at Week-12 as measured by Prognosis and Treatment Perceptions Questionnaire: "Have you and your oncologist discussed any particular wishes about the care you would want to receive if you were dying?" responses at Week-12 are reported below.

Outcome measures

Outcome measures
Measure	Arm 1 (Early Palliative Care) n=99 Participants 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) n=110 Participants 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.
Prognostic Understanding at Week-12 as Measured by "Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying?" Question on the Prognosis and Treatment Perceptions Questionnaire Yes	30 Participants	16 Participants
Prognostic Understanding at Week-12 as Measured by "Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying?" Question on the Prognosis and Treatment Perceptions Questionnaire No	69 Participants	94 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 (Usual Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Temel, MD

Massachusetts General Hospital Cancer Center

Phone: (617) 724-0453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place