Intervention for Fatigue in HCT Recipients

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05715047
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Ashley Nelson, PhD
Phone	617-643-8574
Email	anelson11@mgh.harvard.edu
Status	Recruiting
Phase	N/A
Start date	November 28, 2023
Completion date	September 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Recruiting	`NCT04889937` - Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population
Not yet recruiting	`NCT05820126` - Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial	Phase 2
Active, not recruiting	`NCT04509765` - A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT	N/A
Not yet recruiting	`NCT06350994` - Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Not yet recruiting	`NCT05443854` - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)	Phase 3
Withdrawn	`NCT04282174` - CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies	Phase 2
Withdrawn	`NCT03986086` - MPH966 for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation	Phase 1/Phase 2
Completed	`NCT02512666` - Non Invasive Optical Imaging of WBC Count	N/A
Not yet recruiting	`NCT02193399` - Physiotherapy in Hematopoietic Stem Cell Transplantation	N/A
Withdrawn	`NCT02207764` - Reiki as a Complementary Therapy: A Pilot Study	N/A
Terminated	`NCT01846429` - Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain	Phase 1
Terminated	`NCT01215981` - Influenza Vaccine Post Allogeneic Transplant	N/A
Completed	`NCT00333190` - CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation	N/A
Withdrawn	`NCT04392128` - Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)	Phase 2
Recruiting	`NCT06102213` - Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation	Phase 2
Active, not recruiting	`NCT04552288` - Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies	Phase 2
Completed	`NCT03654404` - A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients	N/A
Recruiting	`NCT05384288` - Response to Influenza Vaccination in Pediatric Oncology Patients
Recruiting	`NCT05084027` - Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT	Phase 2