Cognitive Behavioral Therapy for Insomnia for Cancer-Related Fatigue
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CBT-I sessions conducted weekly via Telehealth, with session numbers varying between four, eight, ten, or twelve based on randomization
Follow-up
Participants are monitored for safety and effectiveness after treatment, including completion of questionnaires on sleep and fatigue
Treatment Details
Interventions
- Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia is already approved in United States, European Union, United Kingdom for the following indications:
- Insomnia
- Depression
- Insomnia
- Depression
- Chronic Insomnia
- Insomnia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abramson Cancer Center at Penn Medicine
Lead Sponsor
University of Pennsylvania
Lead Sponsor
Abramson Cancer Center of the University of Pennsylvania
Lead Sponsor
National Cancer Institute (NCI)
Collaborator