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

NCT04697524 | Completed

• 2 other identifiers: 20806NCI-2020-11397
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Solid Neoplasm; Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm

Keywords

Telehealth; Palliative Care

Outcome Measures

Primary Outcomes (8)

• Develop Categories for intervention refinement (Phase 1)

  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.

  Up to 3 months

• Proportion of participants enrolled

  The proportion of eligible and approached patients who consent to participate.

  14 days

• Retention rate

  The percentage of patients who complete pre and post-treatment questionnaires.

  Up to 3 months

• Adherence rate

  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.

  Up to 3 months

• Number of participants deemed ineligible or refusing to participate

  Number of participants who are determined to be ineligible before 1st virtual visit or refusal to participate before 1st visit and during treatment.

  Up to 3 months

• Frequency of Participant Ineligibility Reason

  For potential study candidates who are ineligible, we will log reasons for ineligibility

  Up to 14 days

• Frequency of Participant Refusal Reason

  For potential study candidates who decide not to participate, we will log reasons for refusal.

  Up to 14 days

• Mean post-treatment participant satisfaction ratings

  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

  1 day

Secondary Outcomes (10)

• Change in distress score on the Edmonton Symptom Assessment System (ESAS)

  Up to 3 months

• Change in scores on the Patient Health Questionnaire-8 (PHQ-8)

  Up to 3 months

• Change in score on the Generalized Anxiety Disorder Assessment (GAD-7)

  Up to 3 months

• Change in score on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Pain Interference- Short Form 4a

  Up to 3 months

• Change in score on the PROMIS Sleep Disturbance- Short Form 6a

  Up to 3 months

Study Arms (2)

Phase 1: Supportive care (GMV)

EXPERIMENTAL

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

Phase 2: Refined GMV

EXPERIMENTAL

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

Interventions

Support Group Therapy BEHAVIORAL

Virtual group meetings

Also known as: Virtual Visit, Telehealth

Phase 1: Supportive care (GMV); Phase 2: Refined GMV

Symptom Management Service (SMS) Consultation BEHAVIORAL

Virtual individual meetings with symptom management service (SMS) over 5 minutes

Also known as: SMS, Virtual Visit

Phase 1: Supportive care (GMV); Phase 2: Refined GMV

Quality of Life (QOL) Questionnaires OTHER

Administered at each study visit

Phase 1: Supportive care (GMV); Phase 2: Refined GMV

Interview OTHER

Virtual exit interview at end of study

Also known as: Virtual Visit

Phase 1: Supportive care (GMV); Phase 2: Refined GMV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Telemedicine; Spermine Synthase; Referral and Consultation; Quality of Life; Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes; Professional Practice; Organization and Administration; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Stephanie Cheng, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 6, 2021
• Study Start: January 26, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)