64 Participants Needed

Cognitive Behavioral Therapy for Insomnia for Cancer-Related Fatigue

AM
MS
Overseen ByMark Seewald
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Abramson Cancer Center at Penn Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12678

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.34579

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.
See 2 more

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.
See 6 more

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 OverviewThe 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
4Treatment groups
Experimental Treatment
Group I: Twelve Sessions of CBT-IExperimental Treatment1 Intervention
Group II: Ten Sessions of CBT-IExperimental Treatment1 Intervention
Group III: Four Sessions of CBT-IExperimental Treatment1 Intervention
Group IV: Eight Sessions of CBT-IExperimental Treatment1 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

Find a Clinic Near You

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.
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.
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.
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]

References

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]
Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. [2023]
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]
A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. [2022]
Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. [2022]
The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. [2023]
Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. [2023]
A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. [2022]
Feasibility of a video-based cognitive behavioral therapy for insomnia in French adult cancer outpatients: results from the Sleep-4-All-1 study. [2021]