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The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

NCT05780814

This study is recruiting at 4 US sites in 2 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Breast Cancer
  • Insomnia
  • Weight Gain

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
18 years and older
Sex
Female
Healthy volunteers
Not accepted
Sponsor
Johns Hopkins University
Last updated on ClinicalTrials.gov
February 23, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

District of Columbia · 1

  • Sibley Memorial Hospital · Washington D.C., DC

Maryland · 3

  • Johns Hopkins Bayview · Baltimore, MD
  • Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins · Baltimore, MD
  • Johns Hopkins Kimmel Cancer Center at Greenspring Station · Lutherville, MD

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.