Clinical trial NCT04390542: Intervention for Caregivers of Patients Undergoing HSCT or CAR T-cell Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Blood Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to identify and recruit dyads in months
timeFrame: 2 months post-hospital discharge, an average of 2 months
measure: Accrual rates
timeFrame: 2 months post-hospital discharge, an average of 2 months
measure: Retention rate
timeFrame: 2 months post-hospital discharge, an average of 2 months
measure: Data collection completion rate
timeFrame: 2 months post-hospital discharge, an average of 2 months
measure: Average acceptability scale scores
timeFrame: 2 months post-hospital discharge, an average of 2 months
measure: Average System Usability Scale scores
timeFrame: 2 months post-hospital discharge, an average of 2 months
measure: Mean caregiver satisfaction
timeFrame: 2 months post-hospital discharge, an average of 2 months
measure: End-of-study caregiver satisfaction scores
timeFrame: 2 months post-hospital discharge, an average of 2 months
Secondary outcomes:
measure: Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores
timeFrame: Baseline, hospital discharge, 2 months post hospital discharge
measure: Caregiver Healthcare Related Quality Of Life (HRQOL)
timeFrame: Baseline, hospital discharge, 2 months post hospital discharge
measure: Distress as measured by the the NCCN distress thermometer
timeFrame: Baseline, hospital discharge, 2 months post hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: Case Western Reserve University
name: Sara Douglas, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: