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

Not Applicable

Completed

Conditions: Lung Cancer

Interventions: Other: Telehealth
Other: In-person PC

Registration Number: NCT03375489

Lead Sponsor: Massachusetts General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1798

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telehealth	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
In Person PC	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

Primary Outcome Measures

Name	Time	Method
Patient-reported Quality of Life	24 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Patient-reported Satisfaction With Care	24 weeks	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.
Patient-reported Communication About Their End-of-Life Care Preferences With Their Clinicians	48 weeks (or last assessment prior to death if before 48 weeks)	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").
Proportion of Patient's Palliative Care Visits With a Caregiver Present	24 weeks	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.
Length of Stay in Hospice	From hospice enrollment until patient death during study period	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.
Caregiver-reported Satisfaction With Care	24 weeks	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.

Trial Locations

Locations (23): Emory University
🇺🇸
Atlanta, Georgia, United States
UT Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
City of Hope
🇺🇸
Los Angeles, California, United States
Johns Hopkins Medicine
🇺🇸
Baltimore, Maryland, United States
Dartmouth-Hitchcock Health
🇺🇸
Lebanon, New Hampshire, United States
Fox Chase Cancer Center
🇺🇸
Philadelphia, Pennsylvania, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
University of Wisconsin
🇺🇸
Madison, Wisconsin, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
University of California - San Francisco
🇺🇸
San Francisco, California, United States
Northwestern University School of Medicine
🇺🇸
Chicago, Illinois, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Vanderbilt University
🇺🇸
Nashville, Tennessee, United States
Mayo Clinic in Rochester
🇺🇸
Rochester, Minnesota, United States
University of North Carolina at Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
University of Texas at Austin
🇺🇸
Austin, Texas, United States
University of Colorado
🇺🇸
Aurora, Colorado, United States
Wake Forest University
🇺🇸
Winston-Salem, North Carolina, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
University of Kansas Medical Center
🇺🇸
Westwood, Kansas, United States