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Cognitive Behavioral Therapy for Leukemia and Lymphoma-related Fatigue

Phase 2
Waitlist Available
Led By Sriram Yennu
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to communicate in English or Spanish.
Zubrod performance status =< 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks or 6 months
Awards & highlights

Study Summary

This trialstudies how CBT helps leukemia/lymphoma patients manage fatigue. CBT uses methods to change thinking/action to cope with cancer-related fatigue, anxiety & depression.

Who is the study for?
This trial is for patients with acute myeloid leukemia or lymphoma who are experiencing cancer-related fatigue. They must have a performance status indicating they can carry out light activity, have had persistent fatigue for at least two weeks, and not be severely anemic. Participants should speak English or Spanish and haven't received cognitive behavioral therapy in the past year.Check my eligibility
What is being tested?
The study is testing whether cognitive behavioral therapy (CBT) can help reduce fatigue in patients with certain types of blood cancers. CBT aims to change thinking and behavior patterns that contribute to patients' anxiety, depression, and overall fatigue levels.See study design
What are the potential side effects?
Cognitive Behavioral Therapy generally does not cause physical side effects but may sometimes lead to emotional discomfort as individuals confront difficult thoughts and feelings during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can communicate in English or Spanish.
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I can take care of myself but might not be able to do heavy physical work.
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I have AML or AML from MDS and feel tired most of the time.
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I have been feeling tired for at least two weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks or 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks or 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to cognitive behavioral therapy (CBT) defined as percentage of the total completed prescribed counseling sessions (7 sessions) the study patient is able to complete
Satisfaction with CBT assessed using a 5 point, fully word-anchored balanced bipolar scale (Satisfaction Assessment).
Secondary outcome measures
Improvement of symptoms determined by M.D. Anderson Symptom Inventory - Acute Myeloid Leukemia / Myelodysplastic Syndromes (MDASI-AML/MDS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive Care (CBT)Experimental Treatment3 Interventions
Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavior Therapy
2010
Completed Phase 3
~2630

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,105 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,733 Total Patients Enrolled
Sriram YennuPrincipal InvestigatorM.D. Anderson Cancer Center
12 Previous Clinical Trials
1,509 Total Patients Enrolled

Media Library

Cognitive Behavior Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03747757 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Supportive Care (CBT)
Acute Myeloid Leukemia Clinical Trial 2023: Cognitive Behavior Therapy Highlights & Side Effects. Trial Name: NCT03747757 — Phase 2
Cognitive Behavior Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03747757 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots available to participate in this clinical experiment?

"The relevant page of clinicaltrials.gov discloses that this particular research is no longer recruiting patients, having first been posted on the 29th November 2018 and last updated on the 5th December 2022. However, at present there are 3269 other studies actively searching for participants."

Answered by AI

Has the FDA accorded its blessing to the usage of Cognitive Behavioral Therapy (CBT) as a form of Supportive Care?

"Our company has evaluated the safety of Supportive Care (CBT) and assigned it a score of 2, since there are some studies supporting its security but none affirming its efficacy."

Answered by AI
~9 spots leftby Sep 2025