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 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.

Trial Details

NCT ID
NCT05780814
Phase
NA
Sponsor
Johns Hopkins University
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Cognitive-Behavioral Therapy for Insomnia (CBT-I)
  • Sleep Education Control (EDU)
Locations (sample)
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Lutherville, Maryland, United States|39.42122,-76.62608

Key Eligibility Criteria

  • 18 years of age or older
  • Histologically-confirmed Ductal Carcinoma In Situ (DCIS) or stage I-III invasive carcinoma of the breast
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs

For full eligibility, visit ClinicalTrials.gov.

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