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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Telehealth
* Other: In-person PC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth<br>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<br>* 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<br>|
| Active Comparator: In Person PC<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient communication about end-of-life (EOL) care preferences as measured by patient self-report of communication about their wishes if they were dying | 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 | up to 5 years | 
| Length of stay in hospice as collected per medical record review | To determine whether telehealth PC is equivalent to in-person PC with respect to length of stay in hospice per medical record review | up to 5 years | 
| Rates of caregiver participation in PC visits will be measured as per PC clinician documentation | To assess the superiority of telehealth versus in-person PC on caregiver participation in PC visits as per PC clinician documentation | up to 5 years | 
| Patient satisfaction as measured by the Satisfaction with Care Delivery Questionnaire | To assess the superiority of telehealth versus in-person PC on patient satisfaction as measured by the Satisfaction and Care Delivery Questionnaire | up to 48 weeks | 
| Caregiver satisfaction as measured by the Satisfaction with Care Delivery Questionnaire | To assess the superiority of telehealth versus in-person PC on caregiver satisfaction as measured by the Satisfaction and Care Delivery Questionnaire | up to 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer palliative care