Clinical trial NCT03375489: Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Lung Cancer
Official title: Comparative Effectiveness of Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer palliative care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Palliative Care Research Cooperative Group
First posted: 2017-12-18
Enrollment: 1798
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported Quality of Life
timeFrame: 24 Weeks
Secondary outcomes:
measure: Patient-reported Communication About Their End-of-Life Care Preferences With Their Clinicians
timeFrame: 48 weeks (or last assessment prior to death if before 48 weeks)
measure: Length of Stay in Hospice
timeFrame: From hospice enrollment until patient death during study period
measure: Proportion of Patient's Palliative Care Visits With a Caregiver Present
timeFrame: 24 weeks
measure: Patient-reported Satisfaction With Care
timeFrame: 24 weeks
measure: Caregiver-reported Satisfaction With Care
timeFrame: 24 weeks
Other outcomes:
measure: Patient-reported Coping Strategies
timeFrame: up to 48 weeks
measure: Patient-reported Prognostic Understanding
timeFrame: up to 48 weeks
measure: Caregiver-reported Prognostic Understanding
timeFrame: up to 48 weeks
measure: Caregiver-reported Quality of Life
timeFrame: up to 48 weeks
measure: Caregiver-reported Mood Symptoms
timeFrame: up to 48 weeks
measure: Patient-reported Mood Symptoms
timeFrame: up to 48 weeks
measure: Patient-reported Depression
timeFrame: up to 48 weeks
measure: Health Care Utilization
timeFrame: Through study completion, average of 18 month follow up
measure: Caregiver-reported Quality of Patient Death
timeFrame: Up to 6 months after patient death during study period
measure: Patient-reported Quality of Life
timeFrame: up to 48 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: City of Hope
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Health
state: New Hampshire
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Massachusetts General Hospital
name: Jennifer Temel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.