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NCT04829539 · ClinicalTrials.gov registry record · Phase 3
Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment
A Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by University of Rochester NCORP Research Base.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT04829539: Recruiting Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by University of Rochester NCORP Research Base.
NCT04829539 is a Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is actively recruiting participants, run by University of Rochester NCORP Research Base. The registered enrollment target is 400 participants, below the 1,139-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04829539, a Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is actively recruiting participants, sponsored by University of Rochester NCORP Research Base.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Will evaluate the mean between arm difference in ISI score change from time point baseline to post-intervention. To assess this, will use analysis of covariance model with ISI at post-intervention as the outcome, study arm (group) as a fixed effect and baseline ISI as a covariate. Will test baseline group interaction.
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 |
What NCT04829539 shows while recruiting
NCT04829539 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,139-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (65% lower).
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.
NCT04829539 names 20 study sites across 6 states, led by Hawaii, Delaware, Colorado.
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.
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).
Who is sponsoring clinical trial NCT04829539?
This trial is sponsored by University of Rochester NCORP Research Base, which has 11 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04829539's enrollment target sits among peer trials
400 36th of 176 higher than 139 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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