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

NCT03337399 | Completed Results

• 2 other identifiers: 17-471R01CA215188
• Study Type: interventional
• Target: 507
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Patient-reported Quality of Life

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

  24 Weeks

Secondary Outcomes (3)

• Proportion of Patients Who Self-report Discussing Their End of Life Care Preferences With Their Clinicians

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

• Length of Stay in Hospice

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

• Palliative Care Resource Utilization

  week 24

Other Outcomes (3)

• Cost-effectiveness

  up to 5 years

• Patients' Prognostic Understanding

  last assessment collected during study or prior to death

• Health Care Utilization

  prior to death or end of study period

Study Arms (2)

Stepped PC

EXPERIMENTAL

* 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

Early Integrated PC

EXPERIMENTAL

* 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

Interventions

Stepped PC OTHER

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

Stepped PC

Early Integrated PC OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Temel JS, Jackson VA, El-Jawahri A, Rinaldi SP, Petrillo LA, Kumar P, McGrath KA, LeBlanc TW, Kamal AH, Jones CA, Rabideau DJ, Horick N, Pintro K, Gallagher Medeiros ER, Post KE, Greer JA. Stepped Palliative Care for Patients With Advanced Lung Cancer: A Randomized Clinical Trial. JAMA. 2024 Aug 13;332(6):471-481. doi: 10.1001/jama.2024.10398.

  PMID: 38824442 DERIVED

• 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.

  PMID: 35588200 DERIVED

• 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.

  PMID: 35144954 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Jennifer Temel
• Organization: Massachusetts General Hospital/Harvard Medical School

jtemel@mgh.harvard.edu

617-724-4000

Study Officials

• Jennifer Temel, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 9, 2017
• Study Start: February 1, 2018
• Primary Completion: July 1, 2023
• Study Completion: December 31, 2023
• Last Updated: May 15, 2025
• Results First Posted: September 3, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)