Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05715047
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-01-27
Brief Title:
Intervention for Fatigue in HCT Recipients
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this study is to assess whether a cognitive-behavioral therapy CBT for fatigue intervention is acceptable feasible and effective at managing fatigue and improving quality of life for patients following hematopoietic stem cell transplant HCT
Detailed Description:
This research is being done to determine whether a cognitive-behavioral therapy CBT for fatigue intervention is feasible and effective at managing fatigue and improving quality of life in patients following hematopoietic stem cell transplant
An open pilot of 6 participants will precede the randomized controlled trial Study procedures for the open pilot include screening for eligibility intervention Zoom sessions questionnaires and exit interviews with study staff
Patients participating in the subsequent randomized controlled trial will be randomized into one of two study groups CBT for fatigue intervention versus usual careStudy procedures include screening for eligibility intervention Zoom sessions intervention arm or receipt of informational materials about fatigue usual care arm and completion of study questionnaires after consent but before randomization and at approximately 3 and 5 months post-randomization
This research study is expected to last about 3 years It is expected about 66 people will take part in this research study
The National Heart Lung and Blood Institute of the National Institute of Health is providing funding for this project
An open pilot of 6 participants will precede the randomized controlled trial Study procedures for the open pilot include screening for eligibility intervention Zoom sessions questionnaires and exit interviews with study staff
Patients participating in the subsequent randomized controlled trial will be randomized into one of two study groups CBT for fatigue intervention versus usual careStudy procedures include screening for eligibility intervention Zoom sessions intervention arm or receipt of informational materials about fatigue usual care arm and completion of study questionnaires after consent but before randomization and at approximately 3 and 5 months post-randomization
This research study is expected to last about 3 years It is expected about 66 people will take part in this research study
The National Heart Lung and Blood Institute of the National Institute of Health is providing funding for this project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None