Intervention for Caregivers of Patients Undergoing HSCT or CAR T-cell Therapy

Study Overview
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Brief Summary
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The purpose of this study is to determine which of two approaches is helpful to support caregivers of patients undergoing Hematopoietic Stem Cell Transplant (HSCT) or Chimeric Antigen Receptors (CAR) T-cell therapy at Seidman Cancer Center. This study will take start before you begin treatment until 2 months after your hospital discharge.

Detailed Description
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This is a two-group, randomized pilot study to test the feasibility, acceptability, usability, satisfaction and preliminary efficacy of a behavioral (psychoeducation) intervention, as compared to a usual care (information from healthcare providers) control group, on caregiver outcomes. The control and intervention groups will receive the standard University Hospitals Seidman Cancer Center (SCC) binder of relevant information regarding care of the patient undergoing HSCT or CAR T-cell therapy. This information will be given to the caregiver by the health care provider. In addition, the intervention group will receive 6 individual sessions with an interventionist during all phases of HSCT or CAR T-cell therapy. The independent variable is group assignment. The primary objective of this study is to explore the feasibility and acceptability of a psycho-educational intervention designed for caregivers of patients receiving HSCT (allogenic or autologous) or CAR T-cell therapy. The secondary objective of this study is to explore the usability, satisfaction and preliminary efficacy of a psycho-educational intervention designed for caregivers of patients receiving HSCT (allogenic or autologous) or CAR T-cell therapy.

Official Title
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A Pilot Study Evaluating Feasibility, Acceptability, Usability, Satisfaction and Preliminary Efficacy of an Intervention for Caregivers of Patients Undergoing HSCT or CAR T-cell Therapy

Conditions
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Blood Cancer

Intervention / Treatment
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* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: Has a diagnosis of blood cancer (leukemia, lymphoma, myeloma, MDS, MPN, CML, CMML) and is scheduled to undergo HCST or CAR T-cell therapy at SCC Will receive HSCT or CAR T-cell therapy and follow-up care from a medical oncologist at University Hospitals Seidman Cancer Center (SCC) Has English as their primary language Provides consent for his/her own treatment and procedures Has an identified caregiver (per SCC-HSCT and CAR T-cell therapy protocol) who will be involved in the patient's care post-HCST or CAR T-cell therapy Caregivers An adult family or friend (at least 18 years old) of a patient scheduled to receive HSCT or CAR T-cell therapy at SCC Identifies himself/herself as the caregiver who will be responsible for the patient's care post-HSCT or CAR T-cell therapy Has English as their primary language Is capable of providing informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychoeducation intervention<br>Psychoeducatoinal intervention | Behavioral: Psychoeducation<br>* 6 sessions (in-person, videoconference, or phone delivery per the caregiver's choice) between the interventionist and caregivers. Topics covered in sessions include: Session 1: Communication, Support, Self Care, Symptom Management Sessions 2-4: Communication, Symptom Management, Support Sessions 5-6: Self-Care, Symptom Management, Communication, Support, Future Planning<br>|
| No Intervention: Usual care<br>Information from healthcare providers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to identify and recruit dyads in months | Feasibility, as measured by time to identify and recruit dyads (benchmark 3 months) | 2 months post-hospital discharge, an average of 2 months | 
| Accrual rates | Feasibility, as measured by accrual rates of eligible participants | 2 months post-hospital discharge, an average of 2 months | 
| Retention rate | Feasibility, as measured by retention rate | 2 months post-hospital discharge, an average of 2 months | 
| Data collection completion rate | Feasibility as measured by completion of data collection across study timepoints | 2 months post-hospital discharge, an average of 2 months | 
| Average acceptability scale scores | Acceptability, as measured by average acceptability scale scores, with overall score ranging from 6-30. According to prior research, a score of 80% of higher (total score of 24 or higher) is considered acceptable for use. | 2 months post-hospital discharge, an average of 2 months | 
| Average System Usability Scale scores | Usability, as measured by average System Usability Scale scores. This is a 10 item scale scored on a 5 point Likert scale with total summed scores ranging from 0-50. Total scores are multiplied by 2 to produce an overall score ranging from 0-100 with scores > 68 considered to be above average usability. | 2 months post-hospital discharge, an average of 2 months | 
| Mean caregiver satisfaction | Caregiver satisfaction will be evaluated by having caregivers evaluate their satisfaction with each of the 6 modules at the end of each module. After completing each module, they will be sent via REDCap a single item evaluation scale (0 -10; 0=Not at all satisfied; 10=Highly satisfied). Scores >7 will be considered acceptable. Mean and standard deviation to describe subjects' overall satisfaction with the intervention reported. | 2 months post-hospital discharge, an average of 2 months | 
| End-of-study caregiver satisfaction scores | End-of-study caregiver satisfaction, as measured by end of study exit interview that assesses overall satisfaction with intervention (Likert Scale). Scores range from 0 to 10, with higher scores indicating more satisfaction. | 2 months post-hospital discharge, an average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores | Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores. Scores range from 1 to 5, with higher scores indicating worse anxiety. Evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender | Baseline, hospital discharge, 2 months post hospital discharge | 
| Caregiver Healthcare Related Quality Of Life (HRQOL) | Caregiver HRQOL, evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender. HRQOL scores range from 1 to 5, with higher scores indicating better outcomes. | Baseline, hospital discharge, 2 months post hospital discharge | 
| Distress as measured by the the NCCN distress thermometer | Distress as measured by the NCCN distress thermometer. Thermometer scores range from 0 to 10, with higher scores indicating worse distress. Prior to administration of the distress thermometer measure, each caregiver will be asked if they are experiencing distress related to Covid-19 (yes/no). The distress thermometer asking them to rate their distress in the past week including today. The Covid-19 variable will be included as a covariate in the analyses. Evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender | Baseline, hospital discharge, 2 months post hospital discharge |