N/A
N=6
Psychological Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)
Stem Cell Transplant Complications
Bottom Line
View on ClinicalTrials.gov: NCT03042715 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Pilot Qualitative Refinement of the Caregiver Intervention — 5; 5; 3; 5 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Qualitative Interviews (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pilot Qualitative Refinement of the Caregiver Intervention |
5; 5; 3; 5 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT03042715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.