Cognitive Behavioral Therapy for Leukemia and Lymphoma-related Fatigue

Overseen By Sriram Yennu

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Prior CBT, Protocol non-compliance, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how cognitive behavioral therapy (CBT) can help individuals with acute myeloid leukemia or lymphoma manage cancer-related fatigue. CBT involves talking with a therapist to learn new ways to think and act, which can alleviate tiredness, anxiety, and depression. Patients with these cancers who have experienced fatigue for at least two weeks and are receiving care at the University of Texas MD Anderson Cancer Center may be suitable for this study. Participants will engage in seven phone counseling sessions, each lasting up to 45 minutes. As a Phase 2 trial, this research measures how well CBT works in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that cognitive behavioral therapy is safe for patients with leukemia and lymphoma-related fatigue?

Research shows that cognitive behavioral therapy (CBT) is safe for patients. Studies have found that it can reduce tiredness, improve quality of life, and boost mood without causing major side effects. This therapy teaches people to change their thoughts and actions, which can lower anxiety and depression. Many cancer patients report feeling better after CBT sessions. The therapy is easy to manage and has been used successfully in various settings, demonstrating positive effects on mental health and resilience. Overall, CBT is considered a safe way to support cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy (CBT) for leukemia and lymphoma-related fatigue because it offers a non-drug approach to managing symptoms. Unlike standard treatments, which often focus on medications to relieve fatigue, CBT provides mental and emotional support through structured counseling sessions. This method helps patients develop coping strategies and potentially improves their quality of life by addressing the psychological aspects of fatigue directly. The convenience of conducting sessions over the phone adds accessibility, making it easier for patients to integrate into their routine care without additional travel or time commitments.

What evidence suggests that cognitive behavioral therapy is effective for leukemia and lymphoma-related fatigue?

Research has shown that cognitive behavioral therapy (CBT), which participants in this trial will receive, can greatly reduce tiredness in cancer patients. Specifically, CBT has effectively lowered fatigue levels in people with chronic myeloid leukemia. One study found a significant drop in tiredness among cancer patients who received CBT, with a noticeable improvement in their fatigue scores. Additionally, the TIRED trial confirmed that CBT helps cancer patients experiencing severe fatigue. These findings suggest that CBT could be a promising way to reduce tiredness related to leukemia and lymphoma. ^{1 6 7 8 9}

Who Is on the Research Team?

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can communicate in English or Spanish.

Seen at leukemia and lymphoma clinics at University of Texas (UT) MD Anderson Cancer Center, Houston, Texas and its affiliates in University of Texas.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I have undergone cognitive behavioral therapy in the last year.

Inability to comply with study protocol procedures.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cognitive behavioral therapy consisting of 7 counseling sessions, up to 45 minutes each over the phone

8 weeks

7 sessions (phone)

Follow-up

Participants are monitored for improvement of symptoms and satisfaction with CBT

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavior Therapy

Trial Overview

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.

How Is the Trial Designed?

Group I: Supportive Care (CBT) Experimental Treatment 3 Interventions

Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.

Cognitive Behavior Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders

Approved in European Union as Cognitive Behavioural Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders
• Post-traumatic stress disorder

Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study of 81 cancer survivors who completed cognitive behavior therapy (CBT) for cancer-related fatigue (CRF) showed that while fatigue levels improved initially, they increased significantly over time, with a mean score rising from 23.7 to 34.4 after an average of 10 years.

Despite the increase in fatigue, 52% of participants who had recovered from severe fatigue after CBT maintained normal fatigue levels at long-term follow-up, suggesting that initial CBT can have lasting benefits, but further support may be needed to address relapses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are the effects of cognitive behavior therapy for severe fatigue in cancer survivors sustained up to 14 years after therapy? Van Gessel, LD., Abrahams, HJG., Prinsen, H., et al.[2019]

Cognitive behavioral therapy for targeted-therapy related fatigue (CBT-TTF) significantly improved fatigue levels in patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKIs), as shown in a pilot study with 36 participants over 18 weeks.

The improvements in fatigue were linked to changes in patients' activity levels and cognitive patterns, such as increased self-efficacy and reduced feelings of helplessness, indicating that CBT-TTF may effectively address both behavioral and psychological factors contributing to fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue Perpetuating Factors as Mediators of Change in a Cognitive Behavioral Intervention for Targeted Therapy-Related Fatigue in Chronic Myeloid Leukemia: A Pilot Study. Hyland, KA., Nelson, AM., Eisel, SL., et al.[2022]

Cognitive Behavioral Therapy (CBT) was found to be feasible and effective in improving cancer-related fatigue (CRF), sleep quality, and anxiety in patients with acute hematological malignancies, with 75% of the 36 enrolled patients completing the study.

After eight weeks of CBT, patients showed a significant improvement in fatigue scores (FACIT-F) and sleep quality (PSQI), indicating that CBT could be a valuable intervention for managing CRF in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Cancer-related-Fatigue in Acute Hematological Malignancies: Results of a Feasibility Study of using Cognitive Behavioral Therapy. Yennurajalingam, S., Konopleva, M., Carmack, CL., et al.[2023]

A study involving 34 childhood cancer survivors (CCS), 102 patients with chronic fatigue syndrome (CFS), and 95 adult cancer survivors (ACS) found that CCS attributed their fatigue more to psychosocial causes and reported fewer sleep/rest problems compared to CFS patients.

CCS reported higher levels of social support but also more depressive symptoms and sleep/rest issues compared to ACS, indicating that tailored cognitive-behavioral therapy (CBT) approaches may be necessary for effectively addressing fatigue in CCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue-Related Cognitive-Behavioral Factors in Survivors of Childhood Cancer: Comparison with Chronic Fatigue Syndrome and Survivors of Adult-Onset Cancer. van Deuren, S., van Dulmen-den Broeder, E., Boonstra, A., et al.[2021]

A pilot study involving 44 patients with chronic myeloid leukemia (CML) showed that cognitive behavioral therapy for targeted therapy-related fatigue (CBT-TTF) significantly improved fatigue levels and quality of life compared to a waitlist control group, with 79% of participants completing the intervention.

Patients receiving CBT-TTF experienced clinically significant improvements, with 85% reporting reduced fatigue and 88% reporting enhanced quality of life, indicating that this intervention could be a promising approach to manage fatigue in CML patients undergoing treatment with tyrosine kinase inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-assisted cognitive behavioral intervention for targeted therapy-related fatigue in chronic myeloid leukemia: Results from a pilot randomized trial. Jim, HSL., Hyland, KA., Nelson, AM., et al.[2023]

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