Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant

Mass General Brigham

Status

Completed

Conditions

Cancer

Treatments

Other: Standard Transplant Care

Other: CARE

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03328663

17-476

CA087723 (Other Grant/Funding Number)

Details and patient eligibility

About

This research study is evaluating the impact of a psychological intervention on the quality of life and mood of caregivers of patients undergoing stem cell transplant.

Full description

The purpose of this study is to find out whether a psychological intervention can make the experience of being a caregiver more manageable by improving the participant's quality of life, mood, and caregiving burden during the participant's loved one's transplant process.

The psychological intervention will entail six visits with a trained clinician and will take place during the first three months of the participant's loved ones' transplant process. A trained behavioral psychologist or social worker will meet with the participant or talk with the participant over the telephone or video conference for 45 minutes at a time to discuss the participant's caregiver experience and to help the participant develop effective skills to support the participant's loved one as well as participant over the course of the transplant.

The study will use a series of questionnaires to measure the participant's quality of life, mood, and overall caregiving burden. Study questionnaires will be completed in the hospital or clinic. The participant will also have the option of completing these questionnaires remotely through a secure web link, over the telephone, or in a mailed paper copy.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult caregivers (≥18 years) of patients undergoing autologous or allogeneic HCT at MGH, and they must attend the HCT consent visit with the patient.
A relative or a friend who either lives with the patient or has in-person contact with him or her at least twice per week and is identified as the primary caregiver for transplant.
Ability to speak English or able to complete questionnaires with minimum assistance of an interpreter.

Exclusion criteria

• Significant uncontrolled psychiatric or other co-morbid disease, which the primary oncologist believes prohibits the ability to participate in study procedures

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

CARE intervention

Experimental group

Description:

* Six psychological intervention sessions in-person or via video conferencing conducted by a trained psychologist * The CARE intervention contain 3 component * a psychoeducational component to address preparednessmanage expectations, and develop caregiving skills * a psychosocial component focusing on coping strategies, mindfulness, and facilitating acceptance while living with uncertainty * a self-care component to promote caregiver health and well-being

Treatment:

Other: CARE

Standard transplant care

Active Comparator group

Description:

* Standard Transplant Care * Social work consults to help caregivers only upon request

Treatment:

Other: CARE

Other: Standard Transplant Care