Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Lung Cancer

NCT03375489 | Completed Results

• 2 other identifiers: 17-484R-1609-35995
• Study Type: interventional
• Target: 1,798
• Locations: 1 country
• Sites: 23

Brief Summary

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

Conditions

Lung Cancer

Keywords

Lung Cancer palliative care

Outcome Measures

Primary Outcomes (1)

• Patient-reported Quality of Life

  Compare the difference between study groups in patient-reported quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Questionnaire, which has a total scale score range from 0-136 with higher scores indicating better overall quality of life.

  24 Weeks

Secondary Outcomes (5)

• Patient-reported Communication About 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 patient death during study period

• Proportion of Patient's Palliative Care Visits With a Caregiver Present

  24 weeks

• Patient-reported Satisfaction With Care

  24 weeks

• Caregiver-reported Satisfaction With Care

  24 weeks

Other Outcomes (10)

• Patient-reported Coping Strategies

  up to 48 weeks

• Patient-reported Prognostic Understanding

  up to 48 weeks

• Caregiver-reported Prognostic Understanding

  up to 48 weeks

Study Arms (2)

Telehealth Palliative Care

EXPERIMENTAL

* Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. * Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. * Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate with no enrolled caregiver.)

Other: Telehealth Palliative Care

In-person Palliative Care

ACTIVE COMPARATOR

* Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic. * In-person palliative care visits will be scheduled on the same day as an oncology visit if possible. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate with no enrolled caregiver.)

Other: In-person Palliative Care

Interventions

Telehealth Palliative Care OTHER

Teleconference meeting with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.

Telehealth Palliative Care

In-person Palliative Care OTHER

In-person meeting with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.

In-person Palliative Care

Eligibility Criteria

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

You may qualify if:

• Patient Eligibility Criteria
• Diagnosed with advanced non-small cell lung cancer 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 3 (symptomatic and in bed \>50% of the day)
• The ability to read and respond to questions in English or Spanish
• Receiving primary cancer care at one of the participating sites
• Age \> or = 18 years
• Lives in a state where their institutions' palliative care clinicians are licensed to practice
• Caregiver Eligibility Criteria
• Relative or friend who is identified by the patient participant and lives with the patient or has contact with them at least twice per week
• The ability to read and respond to questions in English or Spanish
• Age \> or = 18 years

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Palliative Care Research Cooperative Group: collaborator

Study Sites (23)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

City of Hope

Los Angeles, California, 91010, United States

Location

University of California - San Francisco

San Francisco, California, 94121, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University School of Medicine

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Westwood, Kansas, 66205, United States

Location

Johns Hopkins Medicine

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Dartmouth-Hitchcock Health

Lebanon, New Hampshire, 03756, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Vanderbilt University

Nashville, Tennessee, 37204, United States

Location

University of Texas at Austin

Austin, Texas, 78712, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Greer JA, Temel JS, El-Jawahri A, Rinaldi S, Kamdar M, Park ER, Horick NK, Pintro K, Rabideau DJ, Schwamm L, Feliciano J, Chua I, Leventakos K, Fischer SM, Campbell TC, Rabow MW, Zachariah F, Hanson LC, Martin SF, Silveira M, Shoemaker L, Bakitas M, Bauman J, Spoozak L, Grey C, Blackhall L, Curseen K, O'Mahony S, Smith MM, Rhodes R, Cullinan A, Jackson V; REACH PC Investigators. Telehealth vs In-Person Early Palliative Care for Patients With Advanced Lung Cancer: A Multisite Randomized Clinical Trial. JAMA. 2024 Sep 11;332(14):1153-64. doi: 10.1001/jama.2024.13964. Online ahead of print.

  PMID: 39259563 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

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, MD
• Organization: Massachusetts General Hospital

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 30, 2017
• First Posted: December 18, 2017
• Study Start: June 15, 2018
• Primary Completion: April 4, 2024
• Study Completion: December 31, 2024
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)