Active, currently enrolling
Multicenter Randomized Controlled Trial comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)
NCT No.: NCT04829539
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: Colorado
Acronym:
Official Title
Multicenter Randomized Controlled Trial comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)
Purpose
This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-IV cancer who are receiving cancer treatment. Cancer treatment can cause side effects such as sleep problems. Sleep problems such as insomnia, are common for cancer patients. Insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than patient would like. Insomnia can increase fatigue and worsen quality of life. This trial may help researchers determine which treatment works better in reducing insomnia, BBT-CI or HEAL.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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Be at least 18 years of age
Be diagnosed with cancer (stage I, II, III, or IV) with a life expectancy of at least 12 months
Be currently receiving any cancer treatment (surgery alone is excluded)
Report sleep disturbance of 3 or greater on the sleep disturbance question: "Rate your sleep disturbance in the past 2 weeks on a scale from 0-10, 0 is no problems and 10 is having the most severe problems"
Have a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
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Exclusion Criteria
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Have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (even if controlled)
Be engaged in a formal Cognitive Behavioral Therapy for Insomnia program presently or in the past 30 days. Use of psychotropics and sleep medication are allowed
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Keywords and/or Specific Medical Conditions
Sponsors
- University of Rochester NCORP Research Base
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