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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2021-09-30

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.

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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.

Conditions

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Blood Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Psychoeducation intervention

Psychoeducatoinal intervention

Group Type EXPERIMENTAL

Psychoeducation

Intervention Type BEHAVIORAL

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

Usual care

Information from healthcare providers

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychoeducation

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No