Cognitive Behavioral Therapy for Insomnia for Cancer-Related Fatigue

Overseen By Mark Seewald

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Untreated OSA, Narcolepsy, Metastatic disease, Alcohol/drug dependence, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-12 weeks

64 Participants Needed

Trial Summary

What is the purpose of this trial?

Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to de-creases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to CBT-I in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.

Will I have to stop taking my current medications?

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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) for cancer-related fatigue?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective in improving sleep efficiency and reducing insomnia severity in cancer survivors. It also helps improve mood, fatigue, and overall quality of life, making it a strong recommendation for managing sleep issues in cancer patients. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for cancer survivors?

Cognitive Behavioral Therapy for Insomnia (CBT-I), including its digital versions, has been shown to be safe and well-tolerated in cancer survivors, with high satisfaction and retention rates in studies. ^{1 2 6 7 8}

How is Cognitive Behavioral Therapy for Insomnia (CBT-I) unique for treating cancer-related fatigue?

CBT-I is unique because it is a non-drug treatment that uses cognitive and behavior-change techniques to improve sleep and reduce fatigue in cancer patients. It can be delivered in various formats, including digital and self-administered, making it accessible to more patients who might not have access to traditional therapy. ^{3 4 5 7 9}

Eligibility Criteria

This trial is for breast cancer patients aged 25-85 who are experiencing both insomnia and cancer-related fatigue, without significant medical conditions like sleep apnea or psychiatric disorders. Participants must not have metastatic disease, untreated sleep apnea, a history of narcolepsy, substance dependence, or work night shifts.

Inclusion Criteria

I have significant issues with sleep and fatigue.

My breast cancer is limited to the breast.

I am currently undergoing or have completed radiation therapy.

Exclusion Criteria

History of narcolepsy

I have untreated sleep apnea or high scores on the STOP-BANG test.

I have not been diagnosed with breast cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CBT-I sessions conducted weekly via Telehealth, with session numbers varying between four, eight, ten, or twelve based on randomization

4-12 weeks

Weekly sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of questionnaires on sleep and fatigue

4 weeks

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Insomnia

Trial Overview The study tests whether different doses of Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep duration and reduce fatigue in breast cancer patients. It aims to understand if adjusting the amount of CBT-I can lead to better quality of life and survivorship outcomes.

Participant Groups

Group I: Twelve Sessions of CBT-I Experimental Treatment 1 Intervention

Group II: Ten Sessions of CBT-I Experimental Treatment 1 Intervention

Group III: Four Sessions of CBT-I Experimental Treatment 1 Intervention

Group IV: Eight Sessions of CBT-I Experimental Treatment 1 Intervention

Cognitive Behavioral Therapy for Insomnia is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as CBT-I for:

• Insomnia
• Depression

Approved in European Union as CBT-I for:

• Insomnia
• Depression

Approved in United States as Somryst for:

• Chronic Insomnia

Approved in United Kingdom as Sleepio for:

• Insomnia

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The study aims to evaluate the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) compared to sleep hygiene education (SHE) in 308 women with cancer experiencing insomnia, with assessments at 12 and 24 weeks.

The primary outcome will measure changes in sleep quality using the Sleep Condition Indicator (SCI) score, helping to determine if dCBT-I provides better management of insomnia than SHE in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Sleepio after cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial. Treacy, T., O'Meara, Y., Galligan, MC., et al.[2023]

Internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) significantly improved sleep outcomes in 255 breast cancer survivors with clinically significant sleep disturbances, showing a strong effect on insomnia severity (Cohen's d = 1.17).

The benefits of iCBT-I were not only immediate but also sustained at follow-up, indicating its potential as a low-cost and effective treatment option that could be integrated into cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. Zachariae, R., Amidi, A., Damholdt, MF., et al.[2023]

The AYA Can-Sleep programme aims to evaluate the feasibility and acceptability of a stepped-care cognitive behavioural therapy for insomnia (CBTi) approach for adolescents and young adults with cancer, targeting 80 participants aged 16-25.

This study will assess the effectiveness of initial self-management and coaching for sleep difficulties, with further individualized CBT offered if needed, contributing valuable insights into improving sleep health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AYA 'Can-Sleep' programme: protocol for a stepped-care, cognitive behavioural therapy-based approach to the management of sleep difficulties in adolescents and young adults with cancer. Vaughan, E., Ftanou, M., Lewin, J., et al.[2022]

Cognitive behavior therapy for insomnia (CBT-I) significantly improved sleep efficiency by 15.5% in cancer survivors, based on a review of 8 studies involving 752 participants, demonstrating its efficacy in treating insomnia in this population.

Patients receiving CBT-I experienced substantial reductions in sleep latency and wake after sleep onset, with durable effects lasting up to 6 months, supporting a strong recommendation for its use among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. Johnson, JA., Rash, JA., Campbell, TS., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) has been shown to significantly improve sleep quality and psychological outcomes in cancer patients and survivors, based on a review of 12 studies.

CBT-I not only enhances sleep but may also positively affect mood, fatigue, and overall quality of life, and it can be delivered through various methods to reach more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. Garland, SN., Johnson, JA., Savard, J., et al.[2022]

The Survivorship Sleep Program (SSP), a synchronous virtual cognitive behavioral therapy for insomnia (CBT-I) tailored for cancer survivors, demonstrated high feasibility and acceptability, with 90% retention and 100% attendance among participants.

The SSP led to significant reductions in insomnia severity compared to enhanced usual care, with a large effect size (Cohen d = 1.19) that was maintained at a 1-month follow-up, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. Hall, DL., Arditte Hall, KA., Gorman, MJ., et al.[2023]

A pilot study involving 30 Spanish-speaking breast cancer survivors showed that a 6-week eHealth Cognitive-Behavioral Therapy for Insomnia (CBT-I) intervention was highly acceptable and feasible, with excellent recruitment (95%) and retention (97%).

Post-treatment results indicated that CBT-I significantly improved insomnia symptoms, sleep disturbance, and sleep efficiency, with medium to large effect sizes, demonstrating its preliminary efficacy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. Oswald, LB., Morales-Cruz, J., Eisel, SL., et al.[2023]

A pilot study involving 38 cancer survivors showed that a brief, group-based cognitive-behavioral therapy for insomnia (CBT-Insomnia) program significantly improved sleep efficiency, quality, and insomnia symptoms after just three sessions over one month.

Despite experiencing insomnia symptoms for an average of 2.4 years, many survivors had not discussed their sleep issues with healthcare providers, highlighting the need for increased awareness and access to insomnia treatments in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Zhou, ES., Partridge, AH., Recklitis, CJ.[2022]

In a study involving 173 cancer outpatients, 57% reported significant insomnia symptoms, and 80% of those willing to participate found the video-based cognitive behavioral therapy for insomnia (VCBT-I) acceptable, indicating a strong demand for this intervention.

Participants experienced increased knowledge about sleep and improved sleep quality after using VCBT-I, although technical and contextual barriers were noted, suggesting that remote professional support could enhance the effectiveness and personalization of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a video-based cognitive behavioral therapy for insomnia in French adult cancer outpatients: results from the Sleep-4-All-1 study. Boinon, D., Charles, C., Fasse, L., et al.[2021]

References

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

The Sleepio after cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial. [2023]

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

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

AYA 'Can-Sleep' programme: protocol for a stepped-care, cognitive behavioural therapy-based approach to the management of sleep difficulties in adolescents and young adults with cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. [2022]

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

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. [2023]

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

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Feasibility of a video-based cognitive behavioral therapy for insomnia in French adult cancer outpatients: results from the Sleep-4-All-1 study. [2021]