Psychological Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)

Completed

• Conditions: Stem Cell Transplant Complications
• Interventions: Behavioral: Qualitative Interviews

• Registration Number: NCT03042715
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This research study is evaluating a psychological intervention for caregivers of patients undergoing stem cell transplantation.

Phase 1 will include a qualitative phase to refine the intervention to specifically target the needs of caregivers

Phase 2 of the trial will transition to an interventional randomization clinical trial

Detailed Description

The purpose of this study is to find out whether a psychological intervention can help caregivers learn effective coping methods during their loved one's transplant process and make the experience of being a caregiver more manageable.

Phase 1 of the project entails using qualitative interviews with caregivers to further refine the intervention. The psychological intervention will take place over the course of a patient transplant in a series of eight sessions. A trained behavioral psychologist will meet with the participant or talk with them over the telephone for 30-45 minutes at a time to discuss the caregiver experience and to help develop effective skills to support the patient as well as the participant over the course of the transplant.

Upon the completion of the sessions, the investigators will have a short, audio-recorded exit interview to obtain the participant's feedback on the intervention. At the participant's convenience, this interview will be conducted in-person or over the phone. The investigators will use the feedback to improve the intervention before further testing its efficacy in phase 2, a randomized clinical trial.

Study Timeline

• Study First Submitted: 2017-01-28
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Study Start: 2017-03-06
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Results First Submitted: 2018-08-29
• Results First Submitted QC: 2019-12-01
• Results First Posted: 2019-12-18
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Adult caregivers (≥18 years) of patients undergoing HCT at MGH.
• 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 disorder (psychotic disorder, bipolar disorder, major depression)
• Other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psychological Intervention refinement	Qualitative Interviews	* Eight weekly sessions in-person or via telephone * Qualitative interviews * Feedback from 5-10 caregivers to refine the intervention.

Primary Outcome Measures

Name	Time	Method
Pilot Qualitative Refinement of the Caregiver Intervention	1 year	qualitative data to develop and refine the caregiver intervention

Trial Locations

Locations (1)

Massachusetts general Hospital; 🇺🇸 Boston, Massachusetts, United States