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Comparing two approaches to improve sleep for cancer patients undergoing chemotherapy

Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)

Phase 3 Interventional University of Rochester · NCT04829539

This study is testing whether a new therapy for insomnia or healthy eating education can help cancer patients undergoing chemotherapy sleep better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Rochester Academic / other
Locations130 sites (Kingman, Arizona and 129 other locations)
Trial IDNCT04829539 on ClinicalTrials.gov

What this trial studies

This phase III trial evaluates the effectiveness of Brief Behavioral Therapy for Cancer Insomnia (BBT-CI) versus Healthy Eating Education Learning (HEAL) in reducing insomnia among cancer patients receiving treatment. Participants will be randomized into two groups, with one group receiving BBT-CI and the other receiving HEAL, both involving face-to-face or video sessions with trained staff. The primary outcome will be measured using the Insomnia Severity Index (ISI) at the end of the intervention, while secondary outcomes will assess sleep efficiency through actigraphy. Follow-up assessments will occur at six months to evaluate the long-term effects of the interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with stage I-IV cancer who are currently undergoing treatment and experiencing significant sleep disturbances.

Not a fit: Patients with obstructive sleep apnea or restless leg syndrome, or those currently engaged in cognitive behavioral therapy for insomnia, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective non-pharmacological interventions to alleviate insomnia in cancer patients, improving their quality of life.

How similar studies have performed: Previous studies have shown promise in using behavioral interventions for insomnia in cancer patients, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 psychotropics and sleep medication are allowed

Where this trial is running

Kingman, Arizona and 129 other locations

+80 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.