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

Stem Cell Transplant Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042715
• Other study ID #: 16-522
• Status: Completed
• Start date: March 6, 2017
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stem Cell Transplant Complications

Intervention

Behavioral:
• Qualitative Interviews
phase 1 of the study entail refining the psychological intervention based on caregivers' feedback

Locations

Country	Name	City	State
United States	Massachusetts general Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pilot Qualitative Refinement of the Caregiver Intervention	qualitative data to develop and refine the caregiver intervention	1 year