Cognitive-behavioral therapy for fatigue in patients after stem cell transplant
Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation
This study is testing whether cognitive-behavioral therapy can help people who have had a stem cell transplant feel less tired and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05715047 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the acceptability, feasibility, and effectiveness of a cognitive-behavioral therapy (CBT) intervention designed to manage fatigue and enhance the quality of life in patients who have undergone hematopoietic stem cell transplant (HCT). Initially, an open pilot with six participants will be conducted to assess the intervention's practicality. Following this, a randomized controlled trial will compare the CBT intervention against usual care, involving Zoom sessions and questionnaires to gather data on patient outcomes. The study is expected to enroll approximately 66 participants over a duration of three years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone a hematopoietic stem cell transplant more than six months prior and report moderate to severe fatigue.
Not a fit: Patients with active cognitive impairment, uncontrolled psychiatric illness, or those already receiving cognitive-behavioral therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce fatigue and improve the quality of life for patients recovering from hematopoietic stem cell transplant.
How similar studies have performed: Other studies have shown promise in using cognitive-behavioral therapy for managing fatigue in cancer patients, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 * no new other malignancy requiring therapy after transplant * 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 * Patients living with untreated sleep apnea * Patients with hypoxemia requiring oxygen supplementation
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Ashley Nelson, PhD — Massachusetts General Hospital
- Study coordinator: Ashley Nelson, PhD
- Email: anelson11@mgh.harvard.edu
- Phone: 617-643-8574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.