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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy for leukemia and lymphoma-related fatigue?

Research shows that Cognitive Behavioral Therapy (CBT) can help reduce fatigue in cancer patients, including those with blood cancers like leukemia and lymphoma. Studies have found that CBT is effective in managing fatigue related to cancer treatments, and coping interventions, which are part of CBT, have shown moderate success in reducing fatigue in patients with blood cancers. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy safe for humans?

Cognitive Behavioral Therapy (CBT) has been studied for reducing fatigue in cancer patients, including those with leukemia and lymphoma, and is generally considered safe. Studies have shown it can improve fatigue, quality of life, and depressive symptoms without significant safety concerns. ^{1 2 4 5 6}

How is Cognitive Behavioral Therapy (CBT) different from other treatments for leukemia and lymphoma-related fatigue?

Cognitive Behavioral Therapy (CBT) is unique because it focuses on changing thought patterns and behaviors to reduce fatigue, rather than relying on medication. It has shown effectiveness in reducing cancer-related fatigue in various cancer survivors, including those with hematological malignancies, by addressing cognitive and behavioral factors that contribute to fatigue. ^{1 2 3 4 7}

Research Team

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of Cancer-related-Fatigue in Acute Hematological Malignancies: Results of a Feasibility Study of using Cognitive Behavioral Therapy. [2023]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Coping Skills Interventions for Fatigue in Adults with Hematologic Malignancies: A Systematic Review. [2023]

4. United States 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? [2019]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Web-Based Cognitive-Behavioral Therapy to Reduce Severe Cancer-Related Fatigue Among Survivors of Hodgkin Lymphoma: A Feasibility Study. [2023]

7. United States 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. [2021]