Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy

Sponsor

Pack Health (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05064787

Collaborator

M.D. Anderson Cancer Center (Other), Bristol-Myers Squibb (Industry)

Enrollment

Location

Arm

11.7

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Lymphoma, B-Cell Leukemia Multiple Myeloma Mantle Cell Lymphoma Follicular Lymphoma Leukemia, Acute Lymphoblastic	Behavioral: Digital Health Coaching	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A single cohort of 50 individuals receiving chimeric antigen receptor T cell therapy will be enrolled in the study, all of which will be enrolled in a 6-month digital health coaching program. Individuals will be enrolled from a single site, The University of Texas MD Anderson Cancer Center.A single cohort of 50 individuals receiving chimeric antigen receptor T cell therapy will be enrolled in the study, all of which will be enrolled in a 6-month digital health coaching program. Individuals will be enrolled from a single site, The University of Texas MD Anderson Cancer Center.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy

Actual Study Start Date :

Mar 11, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Single Arm Cohort Receiving Digital Health Coaching All study participants will be enrolled in a 6-month digital health coaching program.	Behavioral: Digital Health Coaching The digital health coaching program consists of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application. The program is 6-months in duration and designed for engagement following CAR T cell infusion.

Arm

Intervention/Treatment

Other: Single Arm Cohort Receiving Digital Health Coaching

All study participants will be enrolled in a 6-month digital health coaching program.

Behavioral: Digital Health Coaching

The digital health coaching program consists of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application. The program is 6-months in duration and designed for engagement following CAR T cell infusion.

Outcome Measures

Primary Outcome Measures

Feasibility of the intervention [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 [Through study completion, at month 6]
Acceptability will be assessed with a 3-item evaluation to address engagement, usefulness and relevance

Secondary Outcome Measures

Cancer Behavior Inventory (CBI-B) [Enrollment, Months 1, 3, 6]
This 12-item instrument measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident".
Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) [Enrollment, Months 1, 3, 6]
The FACT-lym is a 42-item assessment that measures self-reported quality of life across 4 domains: physical, functional, emotional and social and includes 15 additional items validated specifically for individuals with lymphoma. The instrument can be scored as a whole as well as within the individual domains.
National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10 [Enrollment, Month 6]
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale is a ten item likert-scale survey that evaluates physical, social, and psychological well-being. The instrument consists of two scales, one for global physical health and one for global mental health.
Subjective Assessment of CAR T Management [Enrollment, Months 1, 3, 6]
a 5-item assessment of patients' experience in monitoring, managing, and reporting treatment related toxicities will be created specifically for use in this study and will mirror the response scale in the CBI-B. This includes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident". The following items will be included: 1) Understand the treatment toxicities I may experience while receiving CAR T-cell therapy; 2) Identify the signs and symptoms of these toxicities; 3) Communicate symptoms to provider; 4) Manage symptoms according to provider's instructions; 5) Explain treatment to a healthcare provider.

Other Outcome Measures

Socio-demographic, clinical, and treatment characteristics [Through study completion, at month 6]
Age, Race, Ethnicity, Sex at Birth, Gender Identity, Diagnosis, Treatment History, Co-morbid conditions
Health Care Utilization [Through study completion, at month 6]
ER visits and unplanned hospitalizations
Digital Engagement [Through study completion, at month 6]
Frequency, types and duration of engagement with the digital health coaching platform

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.