Clinical trial NCT05064787: Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy
Official title: Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Lymphoma, B-Cell
Leukemia
Multiple Myeloma
Mantle Cell Lymphoma
Follicular Lymphoma
Leukemia, Acute Lymphoblastic
Keywords: Receptors, chimeric antigen
Adult
hematologic neoplasms
digital health coaching
Lead sponsor: Pack Health
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
name: Bristol-Myers Squibb
First posted: 2021-10-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: Through study completion, at month 6
measure: Acceptability
timeFrame: Through study completion, at month 6
Secondary outcomes:
measure: Cancer Behavior Inventory (CBI-B)
timeFrame: Enrollment, Months 1, 3, 6
measure: Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
timeFrame: Enrollment, Months 1, 3, 6
measure: National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10
timeFrame: Enrollment, Month 6
measure: Subjective Assessment of CAR T Management
timeFrame: Enrollment, Months 1, 3, 6
Other outcomes:
measure: Socio-demographic, clinical, and treatment characteristics
timeFrame: Through study completion, at month 6
measure: Health Care Utilization
timeFrame: Through study completion, at month 6
measure: Digital Engagement
timeFrame: Through study completion, at month 6
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Sherry Adkins, MSN
role: PRINCIPAL_INVESTIGATOR
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