What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia (AML) include chemotherapy, targeted therapy, and stem cell transplants. Chemotherapy can cause side effects such as fatigue, nausea, hair loss, and increased risk of infections. Targeted therapies may lead to side effects like diarrhea, liver problems, and fluid retention. Stem cell transplants can result in complications such as graft-versus-host disease and infections. Cognitive Behavioral Therapy (CBT), which is used to improve emotional and psychological well-being, generally has minimal physical side effects but may cause temporary emotional discomfort as patients confront challenging thoughts and feelings.

What prior FDA approvals exist?

The context does not provide specific details on FDA-approved drugs for the treatment of Acute Myeloid Leukemia (AML). However, it does highlight a trial investigating the use of Cognitive Behavioral Therapy (CBT) to help AML patients manage cancer-related fatigue. CBT focuses on altering thought patterns and behaviors to improve emotional and psychological well-being, which can be beneficial in managing the mental health aspects of living with AML.

What other types of research exist?

Promising novel alternatives to CBT for AML patients include: 1) Music Therapy, which has been shown to improve psychological and physical outcomes in cancer patients. 2) Guided Imagery and Progressive Muscle Relaxation, which have demonstrated effectiveness in reducing pain and improving quality of life. 3) Mind-Body Therapies such as mindfulness-based stress reduction and biofeedback, which can help manage pain and emotional distress. These therapies offer non-pharmacological options to support emotional and psychological well-being in AML patients.

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Cognitive Behavioral Therapy for Leukemia and Lymphoma-related Fatigue

Q: What is the mechanism of action of this treatment?

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.

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.

Must not have

Prior cancer diagnosis other than noted in the inclusion criterion #1.

Has received CBT (cognitive behavioral therapy) for any indication (e.g. depression, sleep disturbance) in the past 1 year.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 8 weeks or 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well cognitive behavioral therapy (CBT) works in helping patients with acute myeloid leukemia or lymphoma manage cancer-related fatigue. CBT involves talking with a therapist to change thinking and behavior patterns, which can help reduce fatigue and improve emotional well-being. CBT has been shown to be effective in reducing fatigue and improving emotional well-being in various conditions, including chronic fatigue syndrome and cancer-related fatigue.

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.

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.

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

Select...

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.

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a cancer diagnosis different from my current one.

Select...

I have undergone cognitive behavioral therapy in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 8 weeks or 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 8 weeks or 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8 weeks or 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Satisfaction with CBT assessed using a 5 point, fully word-anchored balanced bipolar scale (Satisfaction Assessment).

Secondary study objectives

Improvement of symptoms determined by M.D. Anderson Symptom Inventory - Acute Myeloid Leukemia / Myelodysplastic Syndromes (MDASI-AML/MDS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met

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.