CompletedNot Applicable

Intervention for Fatigue in HCT Recipients

United States66 participantsStarted 2023-11-29

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Satisfaction (Open Pilot only)

Timeframe: 3 month follow-up

Rate of Enrollment

Timeframe: At recruitment

Rate of Retention

Timeframe: Baseline (pre-randomization) up to 5 month follow-up

Rate of Intervention Completion

Timeframe: Baseline (pre-randomization) up to 3 month follow-up

Trial details

NCT IDNCT05715047

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-24

View on ClinicalTrials.gov More Hematologic Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.