Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment
Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)
University of Rochester NCORP Research Base
400 participants
Jun 24, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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
- Be able to speak, understand and read English to participate in the study assessments and interventions
Exclusion Criteria2
- 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 sleep medications are allowed
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Interventions
Receive BBT-CI
Receive HEAL
Ancillary studies
Ancillary studies
Ancillary studies
Locations(153)
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NCT04829539