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Trial Title:
Intervention for Fatigue in HCT Recipients
NCT ID:
NCT05715047
Condition:
Hematologic Cancer
Hematologic Malignancy
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Conditions: Keywords:
Hematologic Cancer
Hematologic Malignancy
Hematopoietic Stem
HCT
Cognitive Behavioral Therapy
CBT
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
CBT for Fatigue
Description:
10, individualized counseling sessions with a behavioral health counselor via Zoom
platform.
Arm group label:
CBT for Fatigue Program
Intervention type:
Behavioral
Intervention name:
Usual Care
Description:
Standard transplant care.
Arm group label:
Usual Care
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 care.Study
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria
- adult patients (≥ 18 years)
- have the ability to speak and read English
- have undergone autologous or allogeneic transplant > 6 months prior to enrollment
- no evidence of disease relapse requiring therapy
- report moderate to severe fatigue in the past week (FSI average severity item rating
≥ 4 of 0-10)
- are currently receiving their care at the MGH Blood and Marrow Transplant Clinic
Exclusion Criteria
- Patients with active cognitive impairment or uncontrolled psychiatric illness such
as schizophrenia that the treating clinician believes prohibits informed consent or
participation in the intervention
- Patients already receiving CBT care
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Nelson, PhD
Phone:
617-643-8574
Email:
anelson11@partners.org
Start date:
November 29, 2023
Completion date:
September 1, 2026
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
National Heart, Lung, and Blood Institute (NHLBI)
Agency class:
NIH
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05715047
