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

Lung Cancer Clinical Trial

— REACH PC  

Official title:

Comparative Effectiveness of Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Advanced Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03375489
• Other study ID #: 17-484
• Secondary ID: R-1609-35995
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1250
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	University of Texas at Austin	Austin	Texas
United States	Johns Hopkins Medicine	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University School of Medicine	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Dartmouth-Hitchcock Health	Lebanon	New Hampshire
United States	City of Hope	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Vanderbilt University	Nashville	Tennessee
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	University of California - San Francisco	San Francisco	California
United States	University of Kansas Medical Center	Westwood	Kansas
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Palliative Care Research Cooperative Group, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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