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NCT05780814 · ClinicalTrials.gov registry record · NA
The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
A NA study of Breast Cancer and Insomnia, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 4
- Study locations
NCT05780814: Recruiting NA study of Breast Cancer and Insomnia, sponsored by Johns Hopkins University.
NCT05780814 is a NA study of Breast Cancer and Insomnia that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 250 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05780814, a NA study of Breast Cancer and Insomnia, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 4
- Study locations
Study Summary
The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior to a sleep education control (EDU) condition followed by behavioral weight loss (EDU+BWL). The investigators will measure outcomes at baseline, 8 weeks (after completing CBT-I or EDU and prior to BWL), and at 3, 6, and 12 months.
Primary Outcome
Our primary endpoint is % total weight loss (TWL) at 12 months. We will measure weight in light clothes without shoes, using a digital scale (in pounds) and height to the nearest 0.1 cm using a calibrated stadiometer, according to standardized procedures.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive-Behavioral Therapy for Insomnia (CBT-I)
- BEHAVIORAL Sleep Education Control (EDU)
Study Locations (4)
Maryland
- Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins - Baltimore
- Johns Hopkins Bayview - Baltimore
- Johns Hopkins Kimmel Cancer Center at Greenspring Station - Lutherville
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-02-01 |
| Est. Completion | 2028-12-31 |
| Phase | NA |
What NCT05780814 shows while recruiting
NCT05780814 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the first listed.
NCT05780814 reports a single indexed study location in Maryland, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05780814 about?
NCT05780814 is a clinical study titled "The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer". The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior ...
What is the current status of trial NCT05780814?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2024-02-01. Estimated completion is 2028-12-31.
What conditions does trial NCT05780814 study?
This clinical trial studies the following conditions: Breast Cancer, Insomnia, Weight Gain.
What interventions are being tested in trial NCT05780814?
The interventions under investigation include: Cognitive-Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL), Sleep Education Control (EDU) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05780814?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05780814 being conducted?
This trial has 4 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT05780814's enrollment target sits among peer trials
250 323rd of 1224 higher than 895 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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