Clinical trial NCT03042715: Psychological Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)
Official title: Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stem Cell Transplant Complications
Keywords: Supportive Care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pilot Qualitative Refinement of the Caregiver Intervention
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts general Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: