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

NCT03042715 | Completed Results DMC

• 1 other identifier: 16-522
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Stem Cell Transplant Complications

Keywords

Supportive Care

Outcome Measures

Primary Outcomes (1)

• Pilot Qualitative Refinement of the Caregiver Intervention

  qualitative data to develop and refine the caregiver intervention

  1 year

Study Arms (1)

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

Interventions

Qualitative Interviews BEHAVIORAL

phase 1 of the study entail refining the psychological intervention based on caregivers' feedback

Psychological Intervention refinement

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

Results Point of Contact

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

ael-jawahri@partners.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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Areej El-Jawahri, MD

Study Record Dates

• First Submitted: January 28, 2017
• First Posted: February 3, 2017
• Study Start: March 6, 2017
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 1, 2021
• Results First Posted: December 18, 2019

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)