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Completed

NCT Number: NCT05064787

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

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.

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Key information

Conditions

Lymphoma Blood Protein Disorders Cardiovascular Diseases Follicular Lymphoma Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Acute Lymphoblastic Leukemia, Lymphoid Lymphatic Diseases Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Precursor Cell Lymphoblastic Leukemia-Lymphoma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital Health Coaching

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  1. 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".

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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

  2. Health Care Utilization

    Time frame: Through study completion, at month 6

    ER visits and unplanned hospitalizations

  3. Digital Engagement

    Time frame: Through study completion, at month 6

    Frequency, types and duration of engagement with the digital health coaching platform

Sponsors and collaborators

Lead sponsor

Pack Health

Industry

Collaborators

  • Bristol-Myers Squibb
  • M.D. Anderson Cancer Center

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2021
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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