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

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

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

Study Overview

• Status: Completed
• Conditions: Stem Cell Transplant Complications
• Intervention / Treatment: Behavioral: Qualitative Interviews

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 Type: Observational
• Enrollment (Actual): 6

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
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Caregivers will be recruited during the patient transplant consent visit, which typically occurs 2-4 weeks prior to admission for HCT. Caregivers are required to attend the HCT consent visit with the patient.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Psychological Intervention refinement; Eight weekly sessions in-person or via telephone; Qualitative interviews; Feedback from 5-10 caregivers to refine the intervention.	Behavioral: Qualitative Interviews; phase 1 of the study entail refining the psychological intervention based on caregivers' feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pilot Qualitative Refinement of the Caregiver Intervention	qualitative data to develop and refine the caregiver intervention	1 year

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: January 28, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Supportive Care
• Other Study ID Numbers: 16-522

Plan for Individual participant data (IPD)

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