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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 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.

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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.

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

FieldValue
Enrollment Target 250 participants
Start Date 2024-02-01
Est. Completion 2028-12-31
Phase NA

Sponsor

Johns Hopkins University

1,448 total trials

What the Registry Record Tells You About NCT05780814

The ClinicalTrials.gov registry entry for NCT05780814 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 2 distinct geographic areas - top geographies include 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.

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