Status:
RECRUITING
Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment
Lead Sponsor:
University of Rochester NCORP Research Base
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVE: I. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index (ISI) at post-intervention. SECONDARY OBJECTIVE: I. Determin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 16 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04829539
Start Date
June 24 2021
End Date
December 16 2026
Last Update
October 17 2025
Active Locations (153)
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1
Kingman Regional Medical Center
Kingman, Arizona, United States, 86401
2
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States, 72903
3
Kaiser Permanente-Franklin
Denver, Colorado, United States, 80205
4
Kaiser Permanente-Rock Creek
Lafayette, Colorado, United States, 80026