Trial Outcomes & Findings for Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies (NCT NCT01401907)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

351 participants

Primary outcome timeframe

12 weeks

Results posted on

2023-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Early Palliative Care 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.	Standard of Care Subjects receives standard of care
Overall Study STARTED	175	175
Overall Study 12 Week Outcomes	148	153
Overall Study COMPLETED	118	124
Overall Study NOT COMPLETED	57	51

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Palliative Care n=175 Participants 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.	Standard of Care n=175 Participants Subjects receives standard of care	Total n=350 Participants Total of all reporting groups
Age, Continuous	65.64 years STANDARD_DEVIATION 11.26 • n=93 Participants	64.03 years STANDARD_DEVIATION 10.46 • n=4 Participants	64.85 years STANDARD_DEVIATION 10.88 • n=27 Participants
Sex: Female, Male Female	84 Participants n=93 Participants	77 Participants n=4 Participants	161 Participants n=27 Participants
Sex: Female, Male Male	91 Participants n=93 Participants	98 Participants n=4 Participants	189 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=93 Participants	2 Participants n=4 Participants	9 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	168 Participants n=93 Participants	173 Participants n=4 Participants	341 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) White	156 Participants n=93 Participants	167 Participants n=4 Participants	323 Participants n=27 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Early Palliative Care n=148 Participants 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.	Standard of Care n=153 Participants Subjects receives standard of care
Functional Assessment of Cancer Therapy (Quality of Life Measure)	81.10 units on a scale Interval 78.11 to 82.08	77.70 units on a scale Interval 75.77 to 79.63

SECONDARY outcome

Timeframe: 24 weeks

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Early Palliative Care n=118 Participants 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.	Standard of Care n=124 Participants Subjects receives standard of care
Functional Assessment of Cancer Therapy (Quality of Life Measure)	81.26 units on a scale Interval 78.89 to 83.63	75.90 units on a scale Interval 73.59 to 78.21

SECONDARY outcome

Timeframe: Week-12 and Week-24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Early Palliative Care n=138 Participants 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.	Standard of Care n=141 Participants Subjects receives standard of care
Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale Week-24	24 Participants	32 Participants
Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale Week-12	29 Participants	32 Participants

SECONDARY outcome

Timeframe: Week12 and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Early Palliative Care n=143 Participants 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.	Standard of Care n=145 Participants Subjects receives standard of care
Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer Goal Cure Week-12	41 Participants	50 Participants
Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer Goal Cure Week-24	37 Participants	32 Participants

SECONDARY outcome

Timeframe: Week-12 and Week-24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Early Palliative Care n=110 Participants 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.	Standard of Care n=119 Participants Subjects receives standard of care
Family Caregiver Quality of Life as Measured by the SF-36 SF36 PCS Week-12	52.94 units on a scale Interval 51.3 to 54.59	51.40 units on a scale Interval 49.83 to 52.98
Family Caregiver Quality of Life as Measured by the SF-36 SF36 MCS Week-12	47.00 units on a scale Interval 45.26 to 48.74	45.92 units on a scale Interval 44.25 to 47.59
Family Caregiver Quality of Life as Measured by the SF-36 SF36 PCS Week-24	52.71 units on a scale Interval 51.02 to 54.4	53.22 units on a scale Interval 51.58 to 54.86
Family Caregiver Quality of Life as Measured by the SF-36 SF36 MCS Week-24	46.21 units on a scale Interval 44.09 to 48.33	45.59 units on a scale Interval 44.09 to 48.33

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: 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.

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

Outcome measures

Outcome measures
Measure	Early Palliative Care n=110 Participants 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.	Standard of Care n=119 Participants Subjects receives standard of care
Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale) HADS-Total Week-12	9.02 units on a scale Interval 8.09 to 9.96	10.48 units on a scale Interval 9.58 to 11.38
Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale) HADS-Total Week-24	9.82 units on a scale Interval 8.65 to 10.99	10.72 units on a scale Interval 8.65 to 10.99

SECONDARY outcome

Timeframe: 12 and 24 weeks

Population: Proportion of caregiver goal is cure at week-12 and week-24. Please note the number of participants reflect those who completed the Perception of Treatment and Prognosis Questionnaire at week-12 and week-24, which explains the discrepancy with the participants flow.

We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Family caregivers reported their primary goal of the 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. Family caregivers' responses were dichotomized as 1) to cure my cancer vs. all other.

Outcome measures

Outcome measures
Measure	Early Palliative Care n=106 Participants 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.	Standard of Care n=113 Participants Subjects receives standard of care
Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer Goal Cure Week-12	34 Participants	40 Participants
Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer Goal Cure Week-24	19 Participants	29 Participants

SECONDARY outcome

Timeframe: Up to week-24

compare mean change in approach oriented coping from baseline to week-24. Approach oriented coping scale is composed of active coping, positive reframing, and acceptance subscales. Scores range from 0-8 with higher scores indicate higher approach-oriented coping

Outcome measures

Outcome measures
Measure	Early Palliative Care n=118 Participants 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.	Standard of Care n=124 Participants Subjects receives standard of care
Coping (Brief Cope)	0.21 units on a scale Interval -0.39 to 0.81	-0.88 units on a scale Interval -1.5 to -0.27

Adverse Events

Early Palliative Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 27 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 32 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Temel MD

MGH

Phone: 617-724-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place