Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Feasibility of the intervention
Study Overview
Brief Summary
The aim of this study is to evaluate the feasibility of a digital health coaching program for, and to describe quality of life of, individuals in the 6 months following chimeric antigen receptor (CAR) T cell therapy. Up to 50 English-speaking individuals aged 18 and older who are to receive treatment with a CAR T cell therapy will be enrolled, all at The University of Texas MD Anderson Cancer Center. Participants must have internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments and will be excluded if they are unable to provide informed consent or have a prognosis of 6 months or less.
Consented participants will be enrolled in a 6-month digital health coaching program delivered via weekly calls from a Health Advisor coupled with the digital delivery of content. The program focuses on identification and escalation of treatment-related toxicity, communication with providers, and physical and psychosocial health following treatment. Health related quality of life (HRQoL) will be assessed with the Functional Assessment of Cancer Therapy-Lymphoma (FACT-L), health self-efficacy will be assessed by the Cancer Behavior Inventory-Brief (CBI-B), physical and mental health outcomes will be measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10. Patient experience in managing CAR T specific care will be assessed with a 5-item questionnaire developed specifically for use in this study, focused on participants' confidence in understanding, identifying and managing symptoms, and communicating with providers. Study outcomes will contribute to knowledge about if and how a digital health intervention may be used to support individuals post-CAR T cell therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 and older
- •Able to read, speak and consent in English
- •Confirmed treatment with any commercially available or investigational CAR T cell therapy.
- •Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.
- •Ability to engage in physical activity as evidenced by an Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2
Exclusion Criteria
- •Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
- •Individuals for whom there is documentation of inability to provide consent in the medical record.
- •Non-English speaking/reading individuals.
Outcomes
Primary Outcomes
Feasibility of the intervention
Time Frame: Through study completion, at month 6
Feasibility is defined as a retention rate in the digital health coaching program greater than or equal to 60% at month 6
Acceptability
Time Frame: Through study completion, at month 6
Acceptability will be assessed with a 3-item evaluation to address engagement, usefulness and relevance
Secondary Outcomes
- Cancer Behavior Inventory (CBI-B)(Enrollment, Months 1, 3, 6)
- National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10(Enrollment, Month 6)
- Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)(Enrollment, Months 1, 3, 6)
- Subjective Assessment of CAR T Management(Enrollment, Months 1, 3, 6)