Randomized Controlled Trial of a Supportive Care Digital Application (THRIVE-CAR-T) for Patients Receiving CAR-T Cell Therapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- CAR T-Cell Therapy
- Sponsor
- Patrick C. Johnson, MD
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Feasibility
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical trial is to learn if a digital mobile application called THRIVE-CAR-T is helpful for the care of patients undergoing CAR-T cell therapy. The main question[s] it aims to answer are whether the THRIVE-CAR-T app is feasible and acceptable to patients.
Detailed Description
This pilot randomized controlled trial aims to examine the feasibility, acceptability, and preliminary effects of a supportive care digital app (THRIVE-CAR-T) versus usual care in patients receiving chimeric antigen receptor T-cell therapy (CAR-T). The primary objective of the study is to determine if THRIVE-CAR-T is feasible and acceptable to patients. The exploratory objective is to assess the preliminary effects of THRIVE-CAR-T for improving patient-reported quality of life (QOL), psychological distress, and self efficacy.
Investigators
Patrick C. Johnson, MD
Assistant Professor of Medicine
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older
- •Ability to understand English
- •Diagnosis of a hematologic malignancy
- •Receiving autologous CAR-T at MGH with an FDA approved cellular therapy product
Exclusion Criteria
- •Impaired cognition or uncontrolled mental illness that prohibits the ability to provide informed consent based on the oncology clinician assessment
- •Already participating in another supportive care clinical trial
Outcomes
Primary Outcomes
Feasibility
Time Frame: Through study completion, an average of 2 years
Feasibility is defined based on the rate of patient enrollment. THRIVE-CAR-T will be deemed feasible if rates of enrollment are \>= 60%, and among those enrolled and randomized to THRIVE-CAR-T, 60% complete 3 out of 5 modules. For patients who either die prior to the end of the intervention or are admitted to the intensive care unit (ICU), the latter definition of feasibility will be completion of 60% of expected modules at the time of clinical deterioration.
Secondary Outcomes
- Acceptability(Through study completion, an average of 2 years)
- Quality of life(From enrollment until 90 days after CAR-T cell therapy)
- Anxiety symptoms(From enrollment until 90 days after CAR-T cell therapy)
- Depression symptoms(From enrollment until 90 days after CAR-T cell therapy)
- PTSD symptoms(From enrollment until 90 days after CAR-T cell therapy)