Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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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CARE intervention

* 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

Group Type EXPERIMENTAL

CARE

Intervention Type OTHER

Promote effective coping and reduce caregiving burden.

Standard transplant care

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

Group Type ACTIVE_COMPARATOR

CARE

Intervention Type OTHER

Promote effective coping and reduce caregiving burden.

Standard Transplant Care

Intervention Type OTHER

Standard cared administered by the hospital.

Interventions

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CARE

Promote effective coping and reduce caregiving burden.

Intervention Type OTHER

Standard Transplant Care

Standard cared administered by the hospital.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes