Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment
NCT04829539 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- BEHAVIORAL Behavioral Intervention
- OTHER Electronic Health Record Review
Study Locations (20)
Hawaii
- Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu
- Queen's Cancer Cenrer - POB I — Honolulu
- Queen's Medical Center — Honolulu
- Straub Clinic and Hospital — Honolulu
- University of Hawaii Cancer Center — Honolulu
- Queen's Cancer Center - Kuakini — Honolulu
- The Cancer Center of Hawaii-Liliha — Honolulu
- Kapiolani Medical Center for Women and Children — Honolulu
- Tripler Army Medical Center — Honolulu
- Hawaii Cancer Care - Westridge — ‘Aiea
Delaware
- Beebe South Coastal Health Campus — Millville
- Helen F Graham Cancer Center — Newark
- Medical Oncology Hematology Consultants PA — Newark
- Beebe Health Campus — Rehoboth Beach
Colorado
- Kaiser Permanente-Franklin — Denver
- Kaiser Permanente-Rock Creek — Lafayette
- Kaiser Permanente-Lone Tree — Lone Tree
Arizona
- Kingman Regional Medical Center — Kingman
Arkansas
- Mercy Hospital Fort Smith — Fort Smith
Georgia
- Memorial Health University Medical Center — Savannah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2026-12-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04829539
The ClinicalTrials.gov registry entry for NCT04829539 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester NCORP Research Base, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions — of which Quality-of-Life Assessment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04829539 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Hawaii, Delaware, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04829539 about?
NCT04829539 is a clinical study titled "Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment". 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...
What is the current status of trial NCT04829539?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2021-06-24. Estimated completion is 2026-12-16.
What conditions does trial NCT04829539 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04829539?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Behavioral Intervention (BEHAVIORAL), Electronic Health Record Review (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04829539?
This trial is sponsored by University of Rochester NCORP Research Base, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04829539 being conducted?
This trial has 20 study locations across Arizona, Arkansas, Colorado, Delaware, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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