Clinical trial NCT04697524: Integrative Palliative Care/Psycho-Oncology Telehealth Intervention in Patients With Advanced Cancer
Official title: Integrative Palliative Care/Psycho-Oncology Telehealth Group Medical Visits for Patients With Advanced Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Malignant Solid Neoplasm
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Keywords: Telehealth
Palliative Care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Develop Categories for intervention refinement (Phase 1)
timeFrame: Up to 3 months
measure: Proportion of participants enrolled
timeFrame: 14 days
measure: Retention rate
timeFrame: Up to 3 months
measure: Adherence rate
timeFrame: Up to 3 months
measure: Number of participants deemed ineligible or refusing to participate
timeFrame: Up to 3 months
measure: Frequency of Participant Ineligibility Reason
timeFrame: Up to 14 days
measure: Frequency of Participant Refusal Reason
timeFrame: Up to 14 days
measure: Mean post-treatment participant satisfaction ratings
timeFrame: 1 day
Secondary outcomes:
measure: Change in distress score on the Edmonton Symptom Assessment System (ESAS)
timeFrame: Up to 3 months
measure: Change in scores on the Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Up to 3 months
measure: Change in score on the Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: Up to 3 months
measure: Change in score on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Pain Interference- Short Form 4a
timeFrame: Up to 3 months
measure: Change in score on the PROMIS Sleep Disturbance- Short Form 6a
timeFrame: Up to 3 months
measure: Change in score on the PROMIS Fatigue - Short Form 6a
timeFrame: Up to 3 months
measure: Change in score on the PROMIS Social Isolation -Short Form 4a Short Form 4a
timeFrame: Up to 3 months
measure: Change in score on the Cancer Behavior Inventory-Brief (CBI-B)
timeFrame: Up to 3 months
measure: Change in score on the Functional Assessment of Cancer Therapy- General (FACT-G)
timeFrame: Up to 3 months
measure: Change in scores on the Quality of Life question
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stephanie Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: