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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Metastatic Malignant Solid Neoplasm; Advanced Malignant Solid Neoplasm; Locally Advanced Malignant Solid Neoplasm

Treatments: Other: Interview; Behavioral: Support Group Therapy; Behavioral: Symptom Management Service (SMS) Consultation; Other: Quality of Life (QOL) Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT04697524

NCI-2020-11397 (Registry Identifier)

20806

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Carry a diagnosis of an advanced solid tumor cancer (locally advanced or metastatic, i.e., stage III or IV cancer)
• Be age >= 18 years
• Be able to speak and read English
• Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
• Be capable of independently utilizing an online platform for telehealth group medical visits in a private setting (assessed by participant self-report)
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Be able to understand a written informed consent document, and be willing to sign it

Exclusion criteria

• Have a cognitive or psychiatric condition prohibiting study consent or participation determined by co-principal investigators (PIs) or referring provider
• Be too medically unstable (or expected to become so during the study period) to participate in a telehealth group medical visit determined by co-PIs or referring providers
• Does not have insurance coverage for telehealth group medical visits
• Have extensive hearing loss such that ability to participate in the study would be impaired as determined by co-PIs or referring provider

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Phase 1: Supportive care (GMV)

Experimental group

Description:

Participants will take a baseline assessment to collect socio-demographic information and complete a series of patient-reported outcome assessments (PROs) prior to their first group medical visit (GMV). The GMV intervention will take place over four weekly sessions conducted virtually. At the completion of all four weekly GMV sessions, participants will be asked to complete an exit survey. Participants in phase one will not be contacted or followed after the exit survey.

Treatment:

Other: Quality of Life (QOL) Questionnaires

Behavioral: Symptom Management Service (SMS) Consultation

Behavioral: Support Group Therapy

Other: Interview

Phase 2: Refined GMV

Experimental group

Description:

Up to three new cohorts of participants are recruited to assess the acceptability and feasibility of the refined intervention based on the results from the Phase 1 group

Treatment:

Other: Quality of Life (QOL) Questionnaires

Behavioral: Symptom Management Service (SMS) Consultation

Behavioral: Support Group Therapy

Other: Interview