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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03375489

Collaborator

Patient-Centered Outcomes Research Institute (Other), Palliative Care Research Cooperative Group (Other)

1,250

Enrollment

Locations

Arms

78.6

Anticipated Duration (Months)

54.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Other: Telehealth Other: In-person PC	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 15, 2018

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) [24 Weeks]
To determine whether telehealth PC is equivalent to in-person PC for improving patients' quality of life as measured by the FACT-L

Secondary Outcome Measures

Patient communication about end-of-life (EOL) care preferences as measured by patient self-report of communication about their wishes if they were dying [up to 5 years]
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
Length of stay in hospice as collected per medical record review [up to 5 years]
To determine whether telehealth PC is equivalent to in-person PC with respect to length of stay in hospice per medical record review
Rates of caregiver participation in PC visits will be measured as per PC clinician documentation [up to 5 years]
To assess the superiority of telehealth versus in-person PC on caregiver participation in PC visits as per PC clinician documentation
Patient satisfaction as measured by the Satisfaction with Care Delivery Questionnaire [up to 48 weeks]
To assess the superiority of telehealth versus in-person PC on patient satisfaction as measured by the Satisfaction and Care Delivery Questionnaire
Caregiver satisfaction as measured by the Satisfaction with Care Delivery Questionnaire [up to 48 weeks]
To assess the superiority of telehealth versus in-person PC on caregiver satisfaction as measured by the Satisfaction and Care Delivery Questionnaire
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy - Lung (FACT-Lung) [up to 48 weeks]
To evaluate whether telehealth PC is equivalent to in-person PC for improving patients' quality of life as measured by the FACT-L

Other Outcome Measures

Patient coping as measured by the Brief Cope [up to 48 weeks]
To compare coping strategies in patients assigned to telehealth versus in-person PC as measured by the Brief Cope
Patient prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire (PTPQ) [up to 48 weeks]
To compare prognostic understanding in patients assigned to telehealth versus in-person PC as measured by the PTPQ
Caregiver prognostic understanding as measured by the Prognosis and Treatment Perception Questionnaire (PTPQ) [up to 48 weeks]
To compare prognostic understanding in caregivers of patients assigned to telehealth versus in-person PC as measured by the PTPQ
Caregiver quality of life (QOL) as measured by the Caregiver Oncology QOL Questionnaire [up to 48 weeks]
To compare the effect of telehealth versus in-person PC on caregivers' QOL as measured by the Caregiver Oncology QOL Questionnaire
Caregiver mood as measured by the Hospital Anxiety and Depression Scale (HADS) [up to 48 weeks]
To compare the effect of telehealth versus in-person PC on caregivers' mood as measured by the HADS
Patient mood as measured by the Hospital Anxiety and Depression Scale (HADS) [up to 48 weeks]
To compare the effect of teleheatlh versus in-person PC on patients' mood as measured by the HADS
Patient depression as measured by the Patient Health Questionnaire-9 (PHQ-9) [up to 48 weeks]
To compare the effect of telehealth versus in-person PC on patients' depression as measured by the PHQ-9
Health care utilization [Through study completion, average of 18 months]
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
Quality of patient death as measured by the After Death Assessment [Up to 6 months after patient death]
To compare the effect of telehealth versus in-person PC on caregiver perceptions of quality of patient death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	City of Hope	Los Angeles	California	United States	91010
3	University of California - San Francisco	San Francisco	California	United States	94121
4	University of Colorado	Aurora	Colorado	United States	80045
5	Emory University	Atlanta	Georgia	United States	30322
6	Northwestern University School of Medicine	Chicago	Illinois	United States	60611
7	Rush University Medical Center	Chicago	Illinois	United States	60612
8	University of Kansas Medical Center	Westwood	Kansas	United States	66205
9	Johns Hopkins Medicine	Baltimore	Maryland	United States	21201
10	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
11	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
12	University of Michigan	Ann Arbor	Michigan	United States	48109
13	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
14	Dartmouth-Hitchcock Health	Lebanon	New Hampshire	United States	03756
15	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27514
16	Wake Forest University	Winston-Salem	North Carolina	United States	27157
17	Cleveland Clinic	Cleveland	Ohio	United States	44195
18	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
19	Vanderbilt University	Nashville	Tennessee	United States	37204
20	University of Texas at Austin	Austin	Texas	United States	78712
21	UT Southwestern Medical Center	Dallas	Texas	United States	75390
22	University of Virginia	Charlottesville	Virginia	United States	22908
23	University of Wisconsin	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

Massachusetts General Hospital
Patient-Centered Outcomes Research Institute
Palliative Care Research Cooperative Group

Investigators

Principal Investigator: Jennifer Temel, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Temel, MD, Principal Investigator, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT03375489

Other Study ID Numbers:

17-484
R-1609-35995

First Posted:

Dec 18, 2017

Last Update Posted:

Mar 25, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jennifer Temel, MD, Principal Investigator, Massachusetts General Hospital

Lung Cancer palliative care

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Mar 25, 2022