Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant

NCT03328663 | Completed Results

• 2 other identifiers: 17-476CA087723
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Cancer Care

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Intervention (Feasibility Description Below)

  Feasibility defined if eligible caregivers randomized to intervention attend at least 50% of the intervention visits

  15 months

Secondary Outcomes (5)

• Compare Caregiver Quality of Life (QOL) as Measured by the Caregiver Oncology QOL (CarGOQOL) Questionnaire Between the Study Arms

  day 60

• Compare Caregiving Burden (CRA) Between the Study Arms

  day 60

• Compare Caregiver Anxiety Using Hospital Anxiety and Depression Scale (HADS) Between the Study Arms

  day 60

• Compare Caregiver Self-efficacy Using the Cancer Self-Efficacy Scale-Transplant (CASE-t) Between the Study Arms

  day 60

• Compare Perceived Coping Skills (MOCS) Between the Study Arms

  day 60

Study Arms (2)

CARE intervention

EXPERIMENTAL

* 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

Other: CARE

Standard transplant care

ACTIVE COMPARATOR

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

Other: CARE; Other: Standard Transplant Care

Interventions

CARE OTHER

Promote effective coping and reduce caregiving burden.

CARE intervention; Standard transplant care

Standard Transplant Care OTHER

Standard cared administered by the hospital.

Standard transplant care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Areej El-Jawahri
• Organization: Massachusetts General Hospital

ael-jawahri@mgb.org

617-724-4000

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 1, 2017
• Study Start: January 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: December 30, 2024
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)