Clinical Trial

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

Study acronym: BBT-II
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-25
minor Completion moved earlier: 2027-09-14 -> 2027-04-12 2026-04-25
Trial Details
NCT Number NCT04829539
Lead Sponsor University of Rochester NCORP Research Base
Collaborators: National Cancer Institute (NCI)
Conditions Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Enrollment 400 participants
Start Date 2021-06-24
Primary Completion 2026-10-14 (estimated)
Study Completion 2027-04-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-24