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

• ClinicalTrials.gov Identifier: NCT03375489
• Recruitment Status: Active, not recruiting
• First Posted: December 18, 2017
• Last Update Posted: March 13, 2024
• Sponsor: Massachusetts General Hospital
• Collaborators: Patient-Centered Outcomes Research Institute; Palliative Care Research Cooperative Group
• Information provided by (Responsible Party): Jennifer Temel, MD, Massachusetts General Hospital

Tracking Information

• First Submitted Date: November 30, 2017
• First Posted Date: December 18, 2017
• Last Update Posted Date: March 13, 2024
• Actual Study Start Date: June 15, 2018
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 14, 2017)

Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 15, 2023)

• Patient communication about end-of-life (EOL) care preferences as measured by patient self-report of communication about their wishes if they were dying [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

Original Secondary Outcome Measures (submitted: December 14, 2017)

• Patient communication about end-of-life (EOL) care preferences as measured by patient self-report of communication about their wishes if they were dying [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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

Current Other Pre-specified Outcome Measures (submitted: December 15, 2023)

• Patient coping as measured by the Brief Cope [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
• Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) [ Time Frame: up to 48 weeks ]
  To compare the effect of Telehealth versus in-person PC on QOL as measured by the FACL-L

Original Other Pre-specified Outcome Measures (submitted: December 14, 2017)

• Patient coping as measured by the Brief Cope [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: up to 48 weeks ]
  To compare the effect of telehealth versus in-person PC on patients' depression as measured by the PHQ-9

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Lung Cancer

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
• 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

Study Arms

• 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
  Intervention: Other: Telehealth
• 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
  Intervention: Other: In-person PC

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: December 14, 2017): 1250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03375489
• Other Study ID Numbers: 17-484; R-1609-35995 ( Other Grant/Funding Number: Patient Centered Outcomes Research Institute )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jennifer Temel, MD, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current

Collaborators

• Patient-Centered Outcomes Research Institute
• Palliative Care Research Cooperative Group

Investigators

• Principal Investigator: Jennifer Temel, MD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: March 2024