CBT for Fatigue in Blood Cancer Patients

Overseen By Ashley Nelson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cognitive impairment, Schizophrenia, Sleep apnea, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a cognitive-behavioral therapy (CBT) program can help manage fatigue and improve quality of life for individuals who have undergone a blood stem cell transplant. Participants will either join the CBT program or continue with their usual care. It suits those who had a blood stem cell transplant more than six months ago and have experienced moderate to severe fatigue in the past week. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance post-transplant care and improve patient outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that CBT for Fatigue is safe for blood cancer patients?

Research has shown that cognitive-behavioral therapy (CBT) can help reduce tiredness in cancer patients, including those with blood cancers. Previous studies combined data from several trials and found CBT effective and safe for managing cancer-related tiredness. Participants in these studies generally handled the therapy well, with few reports of negative side effects. This suggests that CBT is a safe option for managing tiredness in people recovering from blood cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CBT for Fatigue Program because it introduces a psychological approach to managing fatigue in blood cancer patients, which is quite different from the usual care methods focused on physical recovery and medication. Unlike standard treatments that often involve medication or physical therapy, this program uses Cognitive Behavioral Therapy (CBT) to directly address the mental and emotional aspects of fatigue. This approach is particularly promising because it empowers patients with skills and strategies to manage their fatigue symptoms more effectively over time, potentially leading to improved quality of life. By targeting the psychological factors contributing to fatigue, this treatment offers a holistic alternative that could complement traditional medical treatments.

What evidence suggests that CBT for Fatigue might be an effective treatment for fatigue in blood cancer patients?

Research has shown that cognitive-behavioral therapy (CBT) can effectively reduce tiredness in cancer patients, including those with blood cancers. In this trial, some participants will receive the CBT for Fatigue Program, which studies like the TIRED trial have shown to significantly lower tiredness levels among very tired cancer patients. Specifically, improvements in daily activities, sleep, and coping methods, such as reducing negative thoughts, have been linked to feeling less tired after CBT. This therapy has also effectively managed tiredness in various long-term conditions. Overall, evidence supports CBT as a helpful option for managing tiredness in people who have undergone treatments like hematopoietic stem cell transplant. ^{1 2 3 6 7}

Who Is on the Research Team?

Ashley Nelson, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adult patients who have had a stem cell transplant at least 6 months ago, are treated at the MGH Blood and Marrow Transplant Clinic, can speak and read English, and are experiencing moderate to severe fatigue. They must not be in cancer relapse needing treatment or have cognitive impairments that prevent informed consent.

Inclusion Criteria

I have felt very tired or fatigued in the last week.

Currently receiving their care at the MGH Blood and Marrow Transplant Clinic

Ability to speak and read English

Exclusion Criteria

Patients with active cognitive impairment or uncontrolled psychiatric illness such as schizophrenia that the treating clinician believes prohibits informed consent or participation in the intervention

I am currently undergoing cognitive behavioral therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Open Pilot

An open pilot of 6 participants to assess feasibility and acceptability of the intervention

3 months

Multiple Zoom sessions

Randomized Controlled Trial

Participants are randomized into CBT for fatigue intervention or usual care

5 months

10 intervention sessions (virtual) for CBT group

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 months

Questionnaires and surveys at 3 and 5 months post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• CBT for Fatigue
• Usual Care

Trial Overview The study is testing if cognitive-behavioral therapy (CBT) specifically designed for fatigue can help manage tiredness and improve life quality after hematopoietic stem cell transplant compared to usual care without this special CBT.

How Is the Trial Designed?

Group I: CBT for Fatigue Program Experimental Treatment 1 Intervention

Screening for eligibility will use the Fatigue Symptoms Inventory (FSI) average severity item over the prior week. Scores of ≥4 of 0-10 will be invited to participate. 30 participants will be enrolled and will complete study procedures as outlined: * Baseline questionnaires. * 10 intervention sessions. * Questionnaires and surveys 3 and 5 months after enrollment.

Group II: Usual Care Active Control 1 Intervention

Screening for eligibility will use the Fatigue Symptoms Inventory (FSI) average severity item over the prior week. Scores of ≥4 of 0-10 will be invited to participate. 30 participants will be enrolled and will complete study procedures as outlined: * Baseline questionnaires. * Receive adapted material from the MGH Bone Marrow Transplant Survivorship program outlining common contributors to fatigue after transplant and recommendations for management. * Questionnaires and surveys 3 and 5 months after enrollment.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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 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]

Cancer-related fatigue (CRF) is a common and distressing symptom experienced by cancer patients throughout their journey, yet it is often underdiagnosed and poorly managed.

Evidence from controlled trials indicates that interventions like exercise, psycho-educational programs, and cognitive-behavioral therapy for insomnia are effective in treating CRF, highlighting the need for more rigorous studies to identify the best treatments for specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer-related fatigue: state of the science. Mitchell, SA.[2010]

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]

The study involved 50 breast cancer patients undergoing chemotherapy and tested a 7-week nurse-led multi-modal intervention, which was found to be highly acceptable with a 96% adherence rate and no reported adverse events.

The intervention significantly reduced the cancer-related fatigue-sleep disturbance-depressed mood (F-S-D) symptom cluster and improved quality of life, with notable effects observed at both the end of the intervention and three months later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-modal intervention for managing the fatigue-sleep disturbance-depressed mood symptom cluster in breast cancer patients undergoing chemotherapy: A pilot study. Wong, WM., Chan, DNS., Choi, KC., et al.[2023]

In a pragmatic crossover trial involving 89 severely fatigued cancer survivors, graded activity was found to significantly reduce fatigue more than other components of cognitive behavioral therapy (CBT).

The reduction in fatigue from graded activity was mediated by an increase in perceived activity, highlighting its importance in the overall effectiveness of CBT for post-cancer fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graded activity is an important component in cognitive behavioral therapy to reduce severe fatigue: results of a pragmatic crossover trial in cancer survivors. Abrahams, HJG., Gielissen, MFM., Braamse, AMJ., et al.[2020]

Cognitive behavioral therapy (CBT) was found to be feasible and acceptable for patients with chronic myeloid leukemia (CML) experiencing severe fatigue due to tyrosine kinase inhibitors (TKIs), based on a study involving four participants.

While the study showed a trend towards reduced fatigue severity for all participants, the results did not reach statistical significance, indicating the need for further research to confirm the efficacy of CBT in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Treatment-Related Fatigue in Chronic Myeloid Leukemia Patients on Tyrosine Kinase Inhibitors: A Mixed-Method Study. Poort, H., Onghena, P., Abrahams, HJG., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12449572/

Cognitive Behavioral Therapy for Cancer‐Related Fatigue Improvements in self‐reported activity, catastrophizing, self‐efficacy and sleep significantly mediated the effect of CBT on fatigue severity.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06511518

Cognitive Behavioral Therapy for Cancer-related Fatigue in ... From the KWF-sponsored TIRED trial, we concluded that cognitive behavioral therapy (CBT) is effective in reducing fatigue in cancer patients with severe fatigue ...

3. withpower.com withpower.com/trial/phase-neoplasms-6-2023-a62db

CBT for Fatigue in Blood Cancer Patients Research shows that cognitive-behavioral therapy (CBT) can help reduce fatigue in cancer patients, including those with blood cancers.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0005796722002145

The relation between cognitive-behavioural responses to ... Cognitive behavioural therapy (CBT) is effective in reducing fatigue across long-term conditions (LTCs). This study evaluated whether cognitive and behavioural ...

5. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-022-01062-8

Stepped-care cognitive behaviour therapy program for treating ... The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02592447

Cognitive Behavioral Intervention for Targeted Therapy ... The purpose of this study is to evaluate Cognitive Behavioral Intervention for Targeted Therapy Fatigue (CBT-TTF) with fatigued chronic myelogenous leukemia ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6851212/

Cognitive Behavioral Therapy for Treatment-Related ... Two clinical psychologists trained and experienced in CBT for cancer-related fatigue delivered the intervention. CBT for targeted therapy-related fatigue ...