NCT04697524

Integrative Palliative Care/Psycho-Oncology Telehealth Intervention in Patients With Advanced Cancer

Integrative Palliative Care/Psycho-Oncology Telehealth Group Medical Visits for Patients With Advanced Cancer: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial investigates whether a joint and integrative approach to cancer care using palliative care and psycho-oncology is possible, and if it's beneficial to patients with cancer that has spread to other places on the body (advanced). The information gained from this study may help patients to learn about the medicinal and non-medicinal strategies to cope with their symptoms and side effects of their diagnosis and treatment while receiving peer support, in addition to standard individualized medical care.

Detailed description

PRIMARY OBJECTIVES: I. To develop and refine a joint Integrative Palliative Care/Psycho-oncology telehealth group medical visit (GMV) intervention based on feedback from an open pilot study with patient exit interviews. II. To determine the feasibility and acceptability of the telehealth GMVs in a separate, single-arm pilot evaluation among patients with advanced cancer. SECONDARY OBJECTIVE: I. To estimate the preliminary efficacy of the GMVs among patients with advanced cancer. EXPLORATORY OBJECTIVES: I. To assess the financial viability of the GMVs. II. To measure the utilization of other supportive care services at Helen Diller Family Comprehensive Cancer Center (HDFCCC) and the Osher Center 3 months post-treatment. III. To measure the University of California San Francisco (UCSF) healthcare utilization of participants 3 months post treatment. OUTLINE: PHASE I: The group-based intervention is developed, tested, and continuously refined based on participant feedback. Within 14 days of the first weekly group intervention, patients complete baseline questionnaires over 30-45 minutes about their sleep habits, pain management, anxiety/depression, and other symptoms. Patients then participate in a telehealth group medical intervention program over 2 hours weekly for up to 4 sessions where they review topics specific to managing fatigue and sleep habits, managing pain, managing emotional distress, and managing other symptoms and advanced care planning. During the weekly sessions, patients have the opportunity to meet with their symptom management service (SMS) provider in a separate virtual space for individual consultation over 5 minutes to discuss symptoms that they do not feel comfortable sharing in the larger group. The SMS provider may recommend specific interventions or resources for patients to discuss with their oncology, primary care, integrative medicine, psycho-oncology, or palliative care providers as appropriate. Patients also participate in an exit interview over 30 minutes to 1 hour. PHASE II: Based on the feedback given in the first phase, three new cohorts of participants are recruited to assess the acceptability and feasibility of the refined intervention using similar procedures as in Phase I. After completion of study, patients are followed up at 7 and 14 days, and then up to 3 months.

Conditions

• Advanced Malignant Solid Neoplasm
• Locally Advanced Malignant Solid Neoplasm
• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
BEHAVIORAL	Support Group Therapy	Virtual group meetings
BEHAVIORAL	Symptom Management Service (SMS) Consultation	Virtual individual meetings with symptom management service (SMS) over 5 minutes
OTHER	Quality of Life (QOL) Questionnaires	Administered at each study visit
OTHER	Interview	Virtual exit interview at end of study

Timeline

• Start date: 2021-01-26
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2021-01-06
• Last updated: 2023-08-15

Locations

1 site across 1 country: United States