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

May 23, 2024 updated by: Pack Health

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, 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
Through study completion, at month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Behavior Inventory (CBI-B)
Time Frame: 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".
Enrollment, Months 1, 3, 6
Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Time Frame: 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.
Enrollment, Months 1, 3, 6
National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10
Time Frame: 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.
Enrollment, Month 6
Subjective Assessment of CAR T Management
Time Frame: 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.
Enrollment, Months 1, 3, 6

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pack Health

Collaborators

Bristol-Myers Squibb
M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Sherry Adkins, MSN, The University of Texas MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2022

Primary Completion (Actual)

February 6, 2024

Study Completion (Actual)

February 6, 2024

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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