Trial Outcomes & Findings for Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer (NCT NCT03337399)

NCT ID: NCT03337399

Last Updated: 2025-05-15

Results Overview

Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung Range 0-136 with higher scores indicating better quality of life

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 507 participants
• Primary outcome timeframe: 24 Weeks
• Results posted on: 2025-05-15

Participant Flow

Participant milestones

Measure	Stepped PC * Patients will receive Stepped PC * During step 1, patients will be scheduled to meet with the outpatient PC clinician within four weeks of study enrollment and after they are admitted to the hospital or have a change in their cancer treatment * Patients will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) to monitor their quality of life every six weeks and if their quality of life deteriorates substantially, they will "step up" to step 2 of the protocol * Patients who transition to step 2 will then meet with the PC clinician at least every four weeks for the remainder of their illness Stepped PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer	Early Integrated PC * Patients will receive Early Integrated PC * Patients will meet with the PC clinician within four weeks of enrollment and at least every four weeks throughout their course of illness Early Integrated PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer
Overall Study STARTED	250	257
Overall Study COMPLETED	250	257
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer

Baseline characteristics by cohort

Measure	Stepped PC n=250 Participants * Patients will receive Stepped PC * During step 1, patients will be scheduled to meet with the outpatient PC clinician within four weeks of study enrollment and after they are admitted to the hospital or have a change in their cancer treatment * Patients will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) to monitor their quality of life every six weeks and if their quality of life deteriorates substantially, they will "step up" to step 2 of the protocol * Patients who transition to step 2 will then meet with the PC clinician at least every four weeks for the remainder of their illness Stepped PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer	Early Integrated PC n=257 Participants * Patients will receive Early Integrated PC * Patients will meet with the PC clinician within four weeks of enrollment and at least every four weeks throughout their course of illness Early Integrated PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer	Total n=507 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 9.2 • n=5 Participants	66.1 years STANDARD_DEVIATION 11.1 • n=7 Participants	66.5 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex/Gender, Customized Woman	130 participants n=5 Participants	130 participants n=7 Participants	260 participants n=5 Participants
Sex/Gender, Customized Man	120 participants n=5 Participants	126 participants n=7 Participants	246 participants n=5 Participants
Sex/Gender, Customized Other	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Sex/Gender, Customized Missing	0 participants n=5 Participants	1 participants n=7 Participants	1 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	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) White	215 Participants n=5 Participants	212 Participants n=7 Participants	427 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	250 participants n=5 Participants	257 participants n=7 Participants	507 participants n=5 Participants
Functional Assessment of Cancer Therapy - Lung	93.6 units on a scale STANDARD_DEVIATION 19.4 • n=5 Participants	95.7 units on a scale STANDARD_DEVIATION 19.7 • n=7 Participants	94.63 units on a scale STANDARD_DEVIATION 19.60 • n=5 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung Range 0-136 with higher scores indicating better quality of life

Outcome measures

Measure	Stepped PC n=250 Participants * Patients will receive Stepped PC * During step 1, patients will be scheduled to meet with the outpatient PC clinician within four weeks of study enrollment and after they are admitted to the hospital or have a change in their cancer treatment * Patients will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) to monitor their quality of life every six weeks and if their quality of life deteriorates substantially, they will "step up" to step 2 of the protocol * Patients who transition to step 2 will then meet with the PC clinician at least every four weeks for the remainder of their illness Stepped PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer	Early Integrated PC n=257 Participants * Patients will receive Early Integrated PC * Patients will meet with the PC clinician within four weeks of enrollment and at least every four weeks throughout their course of illness Early Integrated PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer
Patient-reported Quality of Life	100.62 score on a scale Interval 98.1 to 103.14	97.75 score on a scale Interval 95.18 to 100.33

SECONDARY outcome

Timeframe: 48 weeks (or last assessment prior to death if before 48 weeks)

Compare the proportion of patients who report that they discussed their end-of-life care preferences with their clinicians based on a single item from the perceptions of prognosis and treatment questionnaire (PTPQ). The PTPQ includes an item that measures patient report of communication about their wishes if they were dying (yes vs. no).

Outcome measures

Measure	Stepped PC n=190 Participants * Patients will receive Stepped PC * During step 1, patients will be scheduled to meet with the outpatient PC clinician within four weeks of study enrollment and after they are admitted to the hospital or have a change in their cancer treatment * Patients will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) to monitor their quality of life every six weeks and if their quality of life deteriorates substantially, they will "step up" to step 2 of the protocol * Patients who transition to step 2 will then meet with the PC clinician at least every four weeks for the remainder of their illness Stepped PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer	Early Integrated PC n=187 Participants * Patients will receive Early Integrated PC * Patients will meet with the PC clinician within four weeks of enrollment and at least every four weeks throughout their course of illness Early Integrated PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer
Proportion of Patients Who Self-report Discussing Their End of Life Care Preferences With Their Clinicians	58 Participants	62 Participants

SECONDARY outcome

Timeframe: From hospice enrollment until death during study period (i.e. 12-month follow up)

Length of stay in hospice as collected per medical record review

Outcome measures

Measure	Stepped PC n=159 Participants * Patients will receive Stepped PC * During step 1, patients will be scheduled to meet with the outpatient PC clinician within four weeks of study enrollment and after they are admitted to the hospital or have a change in their cancer treatment * Patients will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) to monitor their quality of life every six weeks and if their quality of life deteriorates substantially, they will "step up" to step 2 of the protocol * Patients who transition to step 2 will then meet with the PC clinician at least every four weeks for the remainder of their illness Stepped PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer	Early Integrated PC n=161 Participants * Patients will receive Early Integrated PC * Patients will meet with the PC clinician within four weeks of enrollment and at least every four weeks throughout their course of illness Early Integrated PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer
Length of Stay in Hospice	19.5 days Standard Deviation 4.3	34.6 days Standard Deviation 4.2

SECONDARY outcome

Timeframe: week 24

Mean number of palliative care visits

Outcome measures

Measure	Stepped PC n=250 Participants * Patients will receive Stepped PC * During step 1, patients will be scheduled to meet with the outpatient PC clinician within four weeks of study enrollment and after they are admitted to the hospital or have a change in their cancer treatment * Patients will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) to monitor their quality of life every six weeks and if their quality of life deteriorates substantially, they will "step up" to step 2 of the protocol * Patients who transition to step 2 will then meet with the PC clinician at least every four weeks for the remainder of their illness Stepped PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer	Early Integrated PC n=257 Participants * Patients will receive Early Integrated PC * Patients will meet with the PC clinician within four weeks of enrollment and at least every four weeks throughout their course of illness Early Integrated PC: Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer
Palliative Care Resource Utilization	2.4 days Standard Deviation 0.2	4.7 days Standard Deviation 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 5 years

Cost effectiveness as assessed by data collection from the medical record, hospital cost accounting systems, and patient report as per the EuroQOL

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: last assessment collected during study or prior to death

Perception of Treatment and Prognosis Questionnaire (PTPQ)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to death or end of study period

Healthcare utilization as measured the means and proportion of patients who experience emergency department visits, hospital admission, and chemotherapy administration at the end of life between the two groups.

Outcome measures

Outcome data not reported

Adverse Events

Stepped PC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 161 deaths

Early Integrated PC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 164 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Temel

Massachusetts General Hospital/Harvard Medical School

Phone: 617-724-4000

Email: jtemel@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place