Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Lung Cancer (REACH PC)

Comparative Effectiveness of Early Integrated Telehealth Versus In-Person Palliative Care for 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 and their families.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Telehealth Palliative Care; Other: In-person Palliative Care

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.

• Study Type: Interventional
• Enrollment (Actual): 1798
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 91010
      • City Of Hope
    • San Francisco, California, United States, 94121
      • University of California - San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern University School of Medicine
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Johns Hopkins Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Health
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37204
      • Vanderbilt University
  • Texas
    • Austin, Texas, United States, 78712
      • University of Texas at Austin
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

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

Description

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:

• Patient 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

• Caregiver Exclusion Criteria

  • 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: 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.)	Other: 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.
Active Comparator: 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.)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported Communication About Their End-of-Life Care Preferences With Their Clinicians	Compare the difference between study groups in the proportion of patients who reported that they discussed their end-of-life care preferences with their clinicians based on a single item from the Prognosis and Treatment Perceptions Questionnaire (PTPQ). The PTPQ includes a self-report item that assesses whether the patient communicated with their clinicians about their wishes for care if they were dying (i.e., scored dichotomously as "yes vs. no").	48 weeks (or last assessment prior to death if before 48 weeks)
Length of Stay in Hospice	Compare the difference between study groups in the length of stay in hospice (as measured in days) among patients who died during study period per medical record review.	From hospice enrollment until patient death during study period
Proportion of Patient's Palliative Care Visits With a Caregiver Present	Compare the difference between study groups in the proportion of palliative care visits that had a caregiver present as documented by the palliative care clinician using a study visit summary form.	24 weeks
Patient-reported Satisfaction With Care	Compare the difference between study groups in patient-reported satisfaction with care as measured by the Satisfaction and Care Delivery Questionnaire, which has a total scale score range from 0-52 with higher scores indicating greater satisfaction.	24 weeks
Caregiver-reported Satisfaction With Care	Compare the difference between study groups in caregiver-reported satisfaction with care as measured by the Satisfaction and Care Delivery Questionnaire (caregiver version), which has a total scale score range from 0-48 with higher scores indicating greater satisfaction.	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported Coping Strategies	Compare the difference between study groups in patient-reported coping strategies as measured by the Brief Cope (approach-oriented coping score range: 6-24, with higher scores indicating greater use of approach-oriented coping strategies; avoidant coping score range: 4-16, with higher scores indicating greater use of avoidant coping strategies).	up to 48 weeks
Patient-reported Prognostic Understanding	Compare the difference between study groups in patient-reported prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire, in which patients rate two items about the goal of their cancer care (i.e., scored dichotomously as either "to cure my cancer" vs any other option) and whether their cancer is curable (i.e., scored dichotomously as "yes or no").	up to 48 weeks
Caregiver-reported Prognostic Understanding	Compare the difference between study groups in caregiver-reported prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire, in which caregivers rate two items about the goal of their loved one's cancer care (i.e., scored dichotomously as either "to cure his/her cancer" vs any other option) and whether their loved one's cancer is curable (i.e., scored dichotomously as "yes or no").	up to 48 weeks
Caregiver-reported Quality of Life	Compare the difference between study groups in caregiver-reported quality of life as measured by the Caregiver Oncology Quality of Life Questionnaire, which has a total scale score range of 0-100 with higher scores indicating better quality of life.	up to 48 weeks
Caregiver-reported Mood Symptoms	Compare the difference between study groups in caregiver-reported mood symptoms as measured by the Hospital Anxiety and Depression Scale (anxiety subscale score range, 0-21, with higher scores indicating greater anxiety symptoms; depression subscale score range, 0-21, with higher scores indicating greater depression symptoms).	up to 48 weeks
Patient-reported Mood Symptoms	Compare the difference between study groups in patient-reported mood symptoms as measured by the Hospital Anxiety and Depression Scale (anxiety subscale score range, 0-21, with higher scores indicating greater anxiety symptoms; depression subscale score range, 0-21, with higher scores indicating greater depression symptoms).	up to 48 weeks
Patient-reported Depression	Compare the difference between study groups in patient-reported depression as measured by the Patient Health Questionnaire-9, which has a total scale score range from 0-27 with higher scores indicating more significant depression symptoms.	up to 48 weeks
Health Care Utilization	Compare the difference between study groups in health care utilization as per medical record review of emergency department visits, hospital admissions, chemotherapy administration at the end of life, and hospice service use.	Through study completion, average of 18 month follow up
Caregiver-reported Quality of Patient Death	Compare the difference between study groups in caregiver-reported quality of patient death as measured by the After Death Assessment, which includes three items that ask the caregiver to rate the quality of the patient's death (from 1 "worst possible" to 10 "best possible"), the degree of physical distress the patient experienced in their last week of life (from 1 "none" to 10 "extremely distressed"), and the degree of psychological distress the patient experienced in their last week of life (from 1 "none" to 10 "extremely upset").	Up to 6 months after patient death during study period
Patient-reported Quality of Life	Compare the difference between study groups in patient-reported quality of life across all study assessment time points 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 quality of life.	up to 48 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Patient-Centered Outcomes Research Institute; Palliative Care Research Cooperative Group
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Lung Cancer palliative care
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 17-484; R-1609-35995 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)

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