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

• ClinicalTrials.gov Identifier: NCT04697524
• Recruitment Status: Recruiting
• First Posted: January 6, 2021
• Last Update Posted: August 25, 2021
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Advanced Malignant Solid Neoplasm; Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm	Behavioral: Support Group Therapy; Behavioral: Symptom Management Service (SMS) Consultation; Other: Quality of Life (QOL) Questionnaires; Other: Interview	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Integrative Palliative Care/Psycho-Oncology Telehealth Group Medical Visits for Patients With Advanced Cancer: A Pilot Study
• Actual Study Start Date: January 26, 2021
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Phase 1: Supportive care (GMV); 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.	Behavioral: Support Group Therapy; Virtual group meetings; Other Names: Virtual Visit; Telehealth; Behavioral: Symptom Management Service (SMS) Consultation; Virtual individual meetings with symptom management service (SMS) over 5 minutes; Other Names: SMS; Virtual Visit; Other: Quality of Life (QOL) Questionnaires; Administered at each study visit; Other: Interview; Virtual exit interview at end of study; Other Name: Virtual Visit
Experimental: Phase 2: Refined GMV; 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	Behavioral: Support Group Therapy; Virtual group meetings; Other Names: Virtual Visit; Telehealth; Behavioral: Symptom Management Service (SMS) Consultation; Virtual individual meetings with symptom management service (SMS) over 5 minutes; Other Names: SMS; Virtual Visit; Other: Quality of Life (QOL) Questionnaires; Administered at each study visit; Other: Interview; Virtual exit interview at end of study; Other Name: Virtual Visit

Outcome Measures

Primary Outcome Measures :

1. Develop Categories for intervention refinement (Phase 1) [ Time Frame: Up to 3 months ]
   Qualitative methods to analyze participant feedback obtained during exit interviews and code notes from by the existing domains: session relevance, delivery mode, ease of participation, suggested changes. A thematic content analysis will be performed to determine themes based on patterns and responses in these categories. Two coders will then meet to discuss the themes and reach agreement on final categories used to refine intervention for Phase 2 participants.
2. Proportion of participants enrolled [ Time Frame: 14 days ]
   The proportion of eligible and approached patients who consent to participate.
3. Retention rate [ Time Frame: Up to 3 months ]
   The percentage of patients who complete pre and post-treatment questionnaires.
4. Adherence rate [ Time Frame: Up to 3 months ]
   Percentage of patients who complete 2 or more sessions. Will use one-sample negative binomial probability and tests of binomial proportions to compare rates of feasibility to hypothesized values.
5. Number of participants deemed ineligible or refusing to participate [ Time Frame: Up to 3 months ]
   Number of participants who are determined to be ineligible before 1st virtual visit or refusal to participate before 1st visit and during treatment.
6. Frequency of Participant Ineligibility Reason [ Time Frame: Up to 14 days ]
   For potential study candidates who are ineligible, we will log reasons for ineligibility
7. Frequency of Participant Refusal Reason [ Time Frame: Up to 14 days ]
   For potential study candidates who decide not to participate, we will log reasons for refusal.
8. Mean post-treatment participant satisfaction ratings [ Time Frame: 1 day ]
   Participant ratings on intervention convenience, helpfulness, recommendation to others, worth doing, and feeling connected with University of California, San Francisco (UCSF). Descriptive statistics (frequencies, means, and standard deviations (SDs)) and 95% confidence intervals will summarize patients' ratings

Secondary Outcome Measures :

1. Change in distress score on the Edmonton Symptom Assessment System (ESAS) [ Time Frame: Up to 3 months ]
   This 8-item questionnaire is used currently in the Symptom Management Service (SMS) and completed at each visit which measures severity at the time of assessment of each symptom and is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity items (pain, activity, nausea, depression, anxiety, drowsiness, appetite, and sensation of well-being) . The sum of the scores for all symptoms is defined as the symptom distress score.
2. Change in scores on the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Up to 3 months ]
   The PHQ-9 is used to measure depression symptoms. The total Patient Health Questionnaire-9 (PHQ-9) score is calculated by combining the responses of the participant on questions addressing how bothered the participant has been by various problems over the past 2 weeks. Each of the 9 items is scored on a scale of 0 ("Not bothered at all") to 4 ("Nearly every day"). A total score of 5-9='Mild Depression Symptoms", 10-4="Minor Depression, Major Depression (mild), or Dysthymia", 15-19="Major Depression, moderately severe", and >20="Major Depression".
3. Change in score on the Generalized Anxiety Disorder Assessment (GAD-7) [ Time Frame: Up to 3 months ]
   The GAD-7 is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater
4. Change in score on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Pain Interference- Short Form 4a [ Time Frame: Up to 3 months ]
   This 4-item questionnaire to measure the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities based on responses to statements about how the participants feel with a with a response ranging from 1="Never" to 5="Always", and a total raw score ranging from 4 - 20, which are converted to a scaled T-score (range 41.6 to 75.6) with higher scores indicating a greater hinderance to engagement in activities based on how much pain participants are experiencing.
5. Change in score on the PROMIS Sleep Disturbance- Short Form 6a [ Time Frame: Up to 3 months ]
   This 6-item questionnaire to measure sleep disturbance based on responses to statements about how the participants feel with a response ranging from 1="Never" to 5="Always", and a total raw score ranging from 6 - 30, which are converted to a scaled T-score (range 31.7 to 73.3) with higher scores indicating a greater feeling of sleep disturbance.
6. Change in score on the PROMIS Fatigue - Short Form 6a [ Time Frame: Up to 3 months ]
   This 6-item questionnaire to measure fatigue based on responses to statements about how the participants feel with a response ranging from 1="Never" to 5="Always", and a total raw score ranging from 6 - 30, which are converted to a scaled T-score (range 33.4 to 76.8) with higher scores indicating a greater feeling of fatigue.
7. Change in score on the PROMIS Social Isolation -Short Form 4a Short Form 4a [ Time Frame: Up to 3 months ]
   This 4-item questionnaire to measure social isolation based on responses to statements about how the participants feel with a response ranging from 1="Never" to 5="Always", and a total score ranging from 4 - 20 which are converted to a scaled T-score (range 34.8 to 74.2) with higher scores indicating a greater feeling of social isolation.
8. Change in score on the Cancer Behavior Inventory-Brief (CBI-B) [ Time Frame: Up to 3 months ]
   The Cancer Behavior Inventory-Brief Version (CBI-B), a 12-item measure of self-efficacy for coping with cancer. Participants rate each item on how confident they are that they can do that behavior. Responses range from 1 to 9 with 1="Not at all confident", 5="Moderately Confident" and 9="Totally confident". Numbers in the middle of these cut points indicate somewhat confidence in performing these behaviors to a lesser or greater degree but are not specifically labelled. The total score is calculated by summing the scores for the 12 items for a total score range of 12-98, with higher scores indicating greater coping efficacy.
9. Change in score on the Functional Assessment of Cancer Therapy- General (FACT-G) [ Time Frame: Up to 3 months ]
   The FACT-G is a 27-item questionnaire designed to measure four domains of health related quality of life (HRQOL) in cancer patients with 4 domains of interest: Physical, social, emotional, and functional well-being. Each item response score ranges from 0 (not at all) to 5 (very much). The total score is a sum of the subscale scores, with a range from 0 - 108. The higher the score, the better the HRQOL.
10. Change in scores on the Quality of Life question [ Time Frame: Up to 3 months ]
    This is a single-item question, "How would you rate your overall quality of life?" with responses ranging from a scale of 1 to 10 with greater scores indicating a greater quality of life. This is a validated measure used currently in the SMS.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Mara Quinn; (510) 642-7332; mara.quinn@ucsf.edu

Locations

United States, California

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94143

Contact: Austin Fan 510-642-7332 Austin.Fan@ucsf.edu

Contact 877-827-3222 cancertrials@ucsf.edu

Principal Investigator: Stephanie Cheng, MD

Principal Investigator: Neha Goyal, PhD

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Stephanie Cheng, MD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04697524
• Other Study ID Numbers: 20806; NCI-2020-11397 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
• First Posted: January 6, 2021
• Last Update Posted: August 25, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:

Telehealth; Palliative Care

Additional relevant MeSH terms:

Neoplasms