Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer (STEP PC)

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

This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Stepped PC; Other: Early Integrated PC

Detailed Description

Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. In addition, both patients and their loved ones (family and friends) often feel worried or sad about their cancer diagnosis.

Research has shown that early 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. This team is called "palliative care," and consists of physicians and advanced practice nurses (or "nurse practitioners") who work closely and collaboratively with your oncology team to care for the participant and the participant's loved ones. Research shows that when the palliative care team works closely with the oncology team to care for patients with advanced cancer, they may have better symptom control, quality of life, and mood and their loved ones feel less distressed.

This study will compare two different strategies for scheduling participant's visits with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month. The investigators call this strategy "early integrated palliative care".

The second strategy is to schedule the participant to meet with the palliative care clinician after the participant is admitted to the hospital or if the participant's oncology team needs to change the participant cancer treatment, as these are times when the participant is likely to have health issues that the palliative care clinician can help with. The investigators will also monitor the participant's quality of life regularly. If the study team determines that the participant quality of life worsens, the investigators will increase the frequency of the participant's visits with the palliative care clinician to monthly appointments. The investigators call this strategy "stepped palliative care" because the investigators step up the frequency of the participant palliative care visits if the participant's quality of life worsens during the participant cancer treatment.

No matter which strategy the participant is taking part in, the participant will still be able to request additional palliative care visits outside of the study schedule if the participant feel they need them.

• Study Type: Interventional
• Enrollment (Actual): 510
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with advanced non-small cell lung cancer, small cell lung cancer, or mesothelioma, being treated with non-curative intent, and informed of advanced disease within the prior twelve weeks
• Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed <50% of the day)
• The ability to read and respond to questions in English or Spanish
• Primary cancer care at one of the three participating sites
• Age > 18 years

Exclusion Criteria:

• Already receiving outpatient PC or hospice services
• Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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
Experimental: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish that stepped PC is non-inferior to early integrated PC in improving patients' QOL, as measured by the FACT-L	Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung	24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess whether stepped PC is non-inferior to early integrated PC with respect to patient-clinician communication about EOL care preferences	Communication about EOL care preferences as measured by patient self-report of communication about their wishes if they were dying	up to 5 years
Assess whether stepped PC is non-inferior to early integrated PC with respect to length of stay in hospice	Length of stay in hospice as collected per medical record review	up to 5 years
Compare the superiority of stepped PC versus early integrated PC with respect to resource utilization	Utilization of PC services as per medical record review	up to 5 years
Evaluate whether stepped PC is non-inferior to early integrated PC in improving patients' QOL, as measured by the FACT-L	Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung	up to 48 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the superiority of stepped PC versus early integrated PC with respect to cost effectiveness	Cost effectiveness as assessed by data collection from the medical record, hospital cost accounting systems, and patient report as per the EuroQOL	up to 5 years
Compare patients' coping as measured by the Brief Cope between stepped PC and early integrated PC	Coping as measured by the Brief Cope	up to 48 weeks
Compare patients' prognostic understanding as measured by the Perception of Treatment and Prognosis Questionnaire between stepped PC and early integrated PC	Prognostic understanding as per the Perception of Treatment and Prognosis Questionnaire (PTPQ)	up to 48 weeks
Compare patients' depression as measured by the Patient Health Questionnaire-9 (PHQ-9) between stepped PC and early integrated PC	Depression as measured by the Patient Health Questionnaire-9 (PHQ-9)	up to 48 weeks
Health care utilization	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.	up to 5 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jennifer Temel, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Petrillo LA, El-Jawahri A, Heuer LB, Post K, Gallagher ER, Trotter C, Elyze M, Vyas C, Plotke R, Turk YR, Han J, Temel JS, Greer JA. Health-Related Quality of Life and Depression Symptoms in a Cross Section of Patients with Advanced Lung Cancer before and during the COVID-19 Pandemic. J Palliat Med. 2022 Nov;25(11):1639-1645. doi: 10.1089/jpm.2022.0049. Epub 2022 May 19.
• Post KE, Heuer LB, Kamal AH, Kumar P, Elyze M, Griffith S, Han J, Friedman F, Jackson A, Trotter C, Plotke R, Vyas C, Jackson V, Rabideau DJ, Greer JA, Temel JS. Study protocol for a randomised trial evaluating the non-inferiority of stepped palliative care versus early integrated palliative care for patients with advanced lung cancer. BMJ Open. 2022 Feb 10;12(2):e057591. doi: 10.1136/bmjopen-2021-057591.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 17-471; R01CA215188 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No