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: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Telehealth; Other: In-person 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 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): 1250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Temel, MD; Phone Number: 617-724-4000; Email: jtemel@partners.org

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 PC 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; Patients will meet with the PC clinician in person within four weeks of enrollment; Subsequent visits with the PC clinician will be conducted with the patients in their home or other location using video at least every four weeks; Patients may be scheduled to meet with the PC clinician in the clinic if requested by the patient or a clinician	Other: Telehealth; 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 PC; Patients will be scheduled for their first In-person PC visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic; PC visits will be scheduled on the same day as an oncology visit if possible	Other: In-person PC; 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 quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L)	To determine whether telehealth PC is equivalent to in-person PC for improving patients' quality of life as measured by the FACT-L	24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient communication about end-of-life (EOL) care preferences as measured by patient self-report of communication about their wishes if they were dying	To determine whether telehealth PC is equivalent to in-person PC with respect to patient-clinician communication about EOL care preferences as measured by patient self-report of communication about their wishes if they were dying	up to 5 years
Length of stay in hospice as collected per medical record review	To determine whether telehealth PC is equivalent to in-person PC with respect to length of stay in hospice per medical record review	up to 5 years
Rates of caregiver participation in PC visits will be measured as per PC clinician documentation	To assess the superiority of telehealth versus in-person PC on caregiver participation in PC visits as per PC clinician documentation	up to 5 years
Patient satisfaction as measured by the Satisfaction with Care Delivery Questionnaire	To assess the superiority of telehealth versus in-person PC on patient satisfaction as measured by the Satisfaction and Care Delivery Questionnaire	up to 48 weeks
Caregiver satisfaction as measured by the Satisfaction with Care Delivery Questionnaire	To assess the superiority of telehealth versus in-person PC on caregiver satisfaction as measured by the Satisfaction and Care Delivery Questionnaire	up to 48 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient coping as measured by the Brief Cope	To compare coping strategies in patients assigned to telehealth versus in-person PC as measured by the Brief Cope	up to 48 weeks
Patient prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire (PTPQ)	To compare prognostic understanding in patients assigned to telehealth versus in-person PC as measured by the PTPQ	up to 48 weeks
Caregiver prognostic understanding as measured by the Prognosis and Treatment Perception Questionnaire (PTPQ)	To compare prognostic understanding in caregivers of patients assigned to telehealth versus in-person PC as measured by the PTPQ	up to 48 weeks
Caregiver quality of life (QOL) as measured by the Caregiver Oncology QOL Questionnaire	To compare the effect of telehealth versus in-person PC on caregivers' QOL as measured by the Caregiver Oncology QOL Questionnaire	up to 48 weeks
Caregiver mood as measured by the Hospital Anxiety and Depression Scale (HADS)	To compare the effect of telehealth versus in-person PC on caregivers' mood as measured by the HADS	up to 48 weeks
Patient mood as measured by the Hospital Anxiety and Depression Scale (HADS)	To compare the effect of teleheatlh versus in-person PC on patients' mood as measured by the HADS	up to 48 weeks
Patient depression as measured by the Patient Health Questionnaire-9 (PHQ-9)	To compare the effect of telehealth versus in-person PC on patients' depression as measured by the PHQ-9	up to 48 weeks
Health care utilization	To compare the effect of telehealth versus in-person PC on emergency department visits, hospital admissions, chemotherapy administration at the end of life, and hospice service use	Through study completion, average of 18 months
Quality of patient death as measured by the After Death Assessment	To compare the effect of telehealth versus in-person PC on caregiver perceptions of quality of patient death	Up to 6 months after patient death
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L)	To compare the effect of Telehealth versus in-person PC on QOL as measured by the FACL-L	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): December 31, 2023
• Study Completion (Estimated): 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): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lung Cancer palliative care
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 17-484; 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