Study 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.

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

Study Design

Study Type	Interventional
Actual Enrollment	1250 participants
Design Allocation	Randomized
Interventional 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
Study Start Date	June 15, 2018
Actual Primary Completion Date	December 31, 2023
Anticipated Study Completion Date	December 31, 2024

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
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
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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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
2. 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
3. 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
4. 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
5. 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

Eligibility Criteria

Ages Eligible for Study	18 Years and Older (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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

Sponsors and Collaborators	Massachusetts General Hospital, Patient-Centered Outcomes Research Institute, Palliative Care Research Cooperative Group
	Patient-Centered Outcomes Research Institute, Palliative Care Research Cooperative Group
Locations	University of Alabama at Birmingham | Birmingham, Alabama, United States, 35294 City of Hope | Los Angeles, California, United States, 91010 University of California - San Francisco | San Francisco, California, United States, 94121 University of Colorado | Aurora, Colorado, United States, 80045 Emory University | Atlanta, Georgia, United States, 30322 Northwestern University School of Medicine | Chicago, Illinois, United States, 60611 Rush University Medical Center | Chicago, Illinois, United States, 60612 University of Kansas Medical Center | Westwood, Kansas, United States, 66205 Johns Hopkins Medicine | Baltimore, Maryland, United States, 21201 Massachusetts General Hospital | Boston, Massachusetts, United States, 02114 Dana Farber Cancer Institute | Boston, Massachusetts, United States, 02215 University of Michigan | Ann Arbor, Michigan, United States, 48109 Mayo Clinic in Rochester | Rochester, Minnesota, United States, 55905 Dartmouth-Hitchcock Health | Lebanon, New Hampshire, United States, 03756 University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, United States, 27514 Wake Forest University | Winston-Salem, North Carolina, United States, 27157 Cleveland Clinic | Cleveland, Ohio, United States, 44195 Fox Chase Cancer Center | Philadelphia, Pennsylvania, United States, 19111 Vanderbilt University | Nashville, Tennessee, United States, 37204 University of Texas at Austin | Austin, Texas, United States, 78712 UT Southwestern Medical Center | Dallas, Texas, United States, 75390 University of Virginia | Charlottesville, Virginia, United States, 22908 University of Wisconsin | Madison, Wisconsin, United States, 53792
Investigators	Principal Investigator: Jennifer Temel, MD, Massachusetts General Hospital

More Information

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.

Additional Relevant MeSH Terms

• Lung Neoplasms
• Respiratory Tract Neoplasms
• Thoracic Neoplasms
• Neoplasms by Site
• Neoplasms
• Lung Diseases
• Respiratory Tract Diseases