Ignite Creation Date:
2024-05-06 @ 9:40 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03042715
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2017-01-28
Brief Title:
Psychological Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation HCT
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation HCT
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ones 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 participants feedback on the intervention At the participants 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
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 participants feedback on the intervention At the participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None