Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant

Randomized Trial of a Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: CARE; Other: Standard Transplant Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CARE intervention; Six psychological intervention sessions in-person or via video conferencing conducted by a trained psychologist; The CARE intervention contain 3 componenta psychoeducational component to address preparednessmanage expectations, and develop caregiving skillsa psychosocial component focusing on coping strategies, mindfulness, and facilitating acceptance while living with uncertaintya self-care component to promote caregiver health and well-being	Other: CARE; Promote effective coping and reduce caregiving burden.
Active Comparator: Standard transplant care; Standard Transplant Care; Social work consults to help caregivers only upon request	Other: CARE; Promote effective coping and reduce caregiving burden.; Other: Standard Transplant Care; Standard cared administered by the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the intervention (feasibility description below)	Feasibility defined if at least 60% of eligible caregivers are enrolled in the study and attend at least 50% of the intervention visits	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Caregiver QOL (CarGOQOL) between the study arms	we will compare caregiver QOL as measured by CarGOQOL at day +30 and day +90 after the intervention (adjusting for baseline values)	up to day +90
Compare caregiving burden (CRA) between the study arms	we will compare caregiver caregiving burden as measured by Caregiver Reaction Assessment (CRA) at day +30 and day +90 after the intervention (adjusting for baseline values)	up to day +90
Compare caregiver mood (HADS) between the study arms	We will compare caregiver mood use the Hospital Anxiety and Depression Scale (HADS) at day +30 and day +90 (controlling for baseline values). The HADS includes two subscales: depression (range 0 (no distress) to 21 (maximum distress) and anxiety (range 0 (no distress) and 21 (maximum distress))	up to day +90
Compare caregiver self-efficacy (CASE-t) between the study arms	We will compare caregiver self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) at day +30 and day +90 (controlling for baseline values). The scale ranges from 0 to 170 with higher scores indicate higher self efficacy	up to day +90
Compare perceived coping skills (MOCS) between the study arms	Compare caregiver coping skills using the Measure of Current Status (MOCS) between the study arms. Score ranges from 0-52, with higher scores indicating higher coping skills	up to day +90

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 29, 2017
• First Submitted That Met QC Criteria: October 29, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cancer Care
• Other Study ID Numbers: 17-476; CA087723 (Other Grant/Funding Number: NCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No