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

NCT ID: NCT03375489

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1798 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2024-12-31

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.

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 the 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 families 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 the 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 have better symptom control, quality of life, and mood, and their loved ones feel less distressed. the investigators call this model of care, "early integrated palliative care."

While the investigators know that having palliative care clinicians work closely with the oncology team is helpful for patients and their loved ones, many patients do not have access to these specialists because hospitals and cancer clinics lack enough staff and because some patients and family members live in distant regions that make attending clinic visits difficult and expensive. One way to overcome these barriers is to have patients meet with palliative care clinicians using secure video-conferencing technology.

The purpose of this study is to determine if meeting with a palliative care clinician through video-conferencing is just as beneficial for patients and their families as meeting with a palliative care clinician in person. Specifically, this study will compare these two different strategies for meeting with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month in person at the clinic. The investigators call this strategy "In-person palliative care."

The second strategy is to schedule the participant to meet with the palliative care clinician regularly each month using secure video-conferencing, such as through a smart phone or tablet computer. If the participant do not have this form of technology, the investigators will provide it for the participant. The investigators call this strategy "telehealth palliative care." The primary goals of this study are to learn if telehealth palliative care is just as effective as in-person palliative care for improving quality of life, mood symptoms, and satisfaction with care for patients with advanced lung cancer and their families.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telehealth Palliative Care

• 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.)

Group Type: EXPERIMENTAL

Telehealth Palliative Care

Intervention Type: 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.

In-person Palliative Care

• 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.)

Group Type: ACTIVE_COMPARATOR

In-person Palliative Care

Intervention Type: 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.

Interventions

Telehealth Palliative Care

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.

Intervention Type: OTHER

In-person Palliative Care

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Palliative Care Research Cooperative Group

NETWORK

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Temel, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Temel, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope

Los Angeles, California, United States

University of California - San Francisco

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

Emory University

Atlanta, Georgia, United States

Northwestern University School of Medicine

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Kansas Medical Center

Westwood, Kansas, United States

Johns Hopkins Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Dartmouth-Hitchcock Health

Lebanon, New Hampshire, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

University of Texas at Austin

Austin, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39259563 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35588200 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R-1609-35995

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

17-484

Identifier Type: -

Identifier Source: org_study_id