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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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Myeloid Leukemia (AML) include chemotherapy, targeted therapy, and stem cell transplantation. Chemotherapy works by using potent drugs to kill rapidly dividing cancer cells, while targeted therapy focuses on specific genetic mutations within the cancer cells to inhibit their growth. Stem cell transplantation replaces diseased bone marrow with healthy stem cells to restore normal blood cell production. These treatments are crucial for AML patients as they directly target the cancerous cells, aiming to achieve remission. Additionally, cognitive behavioral therapy (CBT) can be beneficial for AML patients by helping them manage the emotional and psychological stress associated with their diagnosis and treatment. CBT works by altering negative thought patterns and behaviors, thereby improving overall emotional well-being and potentially enhancing the patient's ability to cope with the rigorous demands of AML treatment.
Hypnosis or cognitive behavioral training for the reduction of pain and nausea during cancer treatment: a controlled clinical trial.A Brief Mindfulness-Based Cognitive Therapy (MBCT) Intervention as a Population-Level Strategy for Anxiety and Depression.A Randomized Controlled Trial of Emotion Regulation Therapy for Psychologically Distressed Caregivers of Cancer Patients.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,266 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,798,187 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
~9 spots leftby Sep 2025