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CBT for Fatigue in Blood Cancer Patients
N/A
Recruiting
Led By Ashley Nelson, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-randomization) up to 5 month follow-up
Awards & highlights
Study Summary
This trial assesses if a CBT can help fatigue & QoL in people who had a HCT, to see if it's acceptable, feasible & effective.
Who is the study for?
This trial is for adult patients who have had a stem cell transplant at least 6 months ago, are treated at the MGH Blood and Marrow Transplant Clinic, can speak and read English, and are experiencing moderate to severe fatigue. They must not be in cancer relapse needing treatment or have cognitive impairments that prevent informed consent.Check my eligibility
What is being tested?
The study is testing if cognitive-behavioral therapy (CBT) specifically designed for fatigue can help manage tiredness and improve life quality after hematopoietic stem cell transplant compared to usual care without this special CBT.See study design
What are the potential side effects?
Since the intervention involves therapy sessions rather than medication, typical side effects associated with drugs may not apply. However, participants might experience emotional discomfort discussing their experiences during CBT.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-randomization) up to 5 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-randomization) up to 5 month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Enrollment
Rate of Intervention Completion
Rate of Retention
+1 moreSecondary outcome measures
Improvement of Fatigue
Improvement of Mood
Improvement of Quality of Life
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CBT for Fatigue ProgramExperimental Treatment1 Intervention
Screening for eligibility will use the Fatigue Symptoms Inventory (FSI) average severity item over the prior week. Scores of ≥4 of 0-10 will be invited to participate. 30 participants will be enrolled and will complete study procedures as outlined:
Baseline questionnaires.
10 intervention sessions.
Questionnaires and surveys 3 and 5 months after enrollment.
Group II: Usual CareActive Control1 Intervention
Screening for eligibility will use the Fatigue Symptoms Inventory (FSI) average severity item over the prior week. Scores of ≥4 of 0-10 will be invited to participate. 30 participants will be enrolled and will complete study procedures as outlined:
Baseline questionnaires.
Receive material from the Blood and Marrow Transplant Information Network describing common medical causes of fatigue after HCT and recommendations for management.
Questionnaires and surveys 3 and 5 months after enrollment.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,575 Total Patients Enrolled
1 Trials studying Blood Cancers
90 Patients Enrolled for Blood Cancers
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,058 Total Patients Enrolled
Ashley Nelson, PhDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing cognitive behavioral therapy.My condition has not worsened to need treatment again.I had a stem cell transplant more than 6 months ago.I have felt very tired or fatigued in the last week.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: CBT for Fatigue Program
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available openings for participants in this research?
"Reports on clinicaltrials.gov reveal that this medical trial, which initially opened applications in the summer of 2023 with its last edit occuring in March, is not currently seeking participants. However, prospective patients can discover 2492 other studies actively recruiting at present."
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