Active — Not RecruitingPhase 3

Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment

United States400 participantsStarted 2021-06-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Insomnia Severity Index (ISI)

Timeframe: post intervention

Trial details

NCT IDNCT04829539

SponsorUniversity of Rochester NCORP Research Base

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-14

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