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Integrated Telehealth or In-Person Palliative Care in Improving Quality of Life in Patients with Advanced Non-small Cell Lung Cancer

Status
Closed
Cancer Type
Lung Cancer
Unknown Primary
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Supportive care
NCT ID
NCT03375489
Protocol IDs
17-484 (primary)
NCI-2018-00225
Study Sponsor
Dana-Farber Harvard Cancer Center

Summary

This randomized clinical trial studies how well integrated telehealth or in-person palliative care works in improving quality of life in patients with non-small lung cancer that has spread to other places in the body (advanced). Early involvement in palliative care may lesson many of the distressing physical and emotional symptoms and help patients and their families cope with serious illness as well as improve patients’ and their loved ones’ experience with cancer. Integrated telehealth palliative care involves patients meeting with palliative care clinicians using secure video-conferencing technology. It is not yet known whether giving integrated telehealth or in-person palliative care works better for patients and their families in improving quality of life.

Objectives

PRIMARY OBJECTIVE:
I. To determine whether telehealth palliative care (PC) is equivalent to in-person PC for improving patients’ quality of life (QOL).

SECONDARY OBJECTIVES:
I. To determine whether telehealth PC is equivalent to in-person PC with respect to patient-clinician communication about end of life (EOL) care preferences and length of stay in hospice.
II. To compare the effect of telehealth versus in-person PC on caregiver participation in PC visits.
III. To compare patient and caregiver satisfaction with telehealth versus in-person PC.

EXPLORATORY OBJECTIVES:
I. To compare coping strategies in patients assigned to telehealth versus in- person PC.
II. To compare prognostic understanding in patients and caregivers assigned to telehealth.
III. To compare the effect of telehealth versus in person PC on caregivers’ outcomes, including QOL and mood.
IV. To compare the effect of telehealth versus in-person PC on patients’ mood.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive video-conference palliative care every 4 weeks over 30 minutes.

GROUP II: Patients receive in-person palliative care every 4 weeks over 30 minutes.

After completion of study, patients are followed periodically.

Eligibility

  1. PATIENT: Diagnosed with advanced non-small cell lung carcinoma (NSCLC) being treated with non-curative intent, and informed of advanced disease within the prior twelve weeks
  2. PATIENT: Eastern Cooperative Oncology Group (ECOG) performance status from 0 (asymptomatic) to 3 (symptomatic and in bed > 50% of the day)
  3. PATIENT: The ability to read and respond to questions in English or Spanish
  4. PATIENT: Receiving primary cancer care at one of the participating sites
  5. PATIENT: Age >= 18 years
  6. CAREGIVER: 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
  7. CAREGIVER: The ability to read and respond to questions in English or Spanish
  8. CAREGIVER: Age >= 18 years

Treatment Sites in Georgia

Emory University Hospital - Atlanta


1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.