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

Launched by JOHNS HOPKINS UNIVERSITY · Mar 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how treating insomnia can help women with a history of breast cancer lose weight. The researchers will compare two groups: one group will receive a short therapy program to help improve their sleep, while the other group will get general sleep education. After this initial phase, both groups will then participate in a weight loss program. The trial will track participants' progress over time, checking in at different points like 8 weeks, 3 months, 6 months, and 12 months to see the impact on their weight and overall health.

To be eligible for this trial, participants must be women aged 18 or older who have been diagnosed with early-stage breast cancer and are currently experiencing insomnia. They should have a body mass index (BMI) of 25 or higher and be willing to lose about 10% of their body weight. Participants will need to have completed their cancer treatments at least three months before joining the study. Throughout the trial, participants can expect support and guidance as they work on improving their sleep and achieving their weight loss goals. This study is currently recruiting participants, so anyone interested should reach out for more details.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female
• • 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
• • Willing to lose 10% of body weight
• • Diagnosed within 10 years with histologically-confirmed DCIS or stage I-III invasive carcinoma of the breast
• • Completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy/immunotherapy(/HER2) human epidermal growth factor receptor 2 therapy/targeted therapy at least 3months prior to enrollment (concomitant endocrine therapy allowed)
• • Completed all planned/elective surgeries \>4 weeks before enrollment
• • Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia disorder
• • Self-reported initial sleep onset time and/or wake after sleep onset (WASO) time \> 30 minutes, \> 3 nights/week
• • Reports sleep problems present for ≥ 3 months
• • Insomnia Severity Index Score ≥ 9
• Exclusion Criteria:
• • Serious/uncontrolled medical or psychiatric condition likely to hinder participation in BWL or CBT-l (bipolar disorder, psychotic disorder, seizure disorders, autoimmune disease, etc.)
• • Current use of medications that cause sleep disturbances or weight gain/loss. (-) Current sedative hypnotic use
• • Sleep disorder other than insomnia (mild sleep apnea or moderate to severe sleep apnea successfully treated via positive airway pressure (PAP) therapy is permitted
• • Currently enrolled or planning to enroll in a sleep treatment or weight loss program (agree not to enroll for the duration of the study) (-) Home sleep test Apnea/hypopnea Index (AHI) \> 15
• • Participants also agree not to enroll in such a program for the duration of study participation (regardless of randomization).
• • History of unstable psychiatric disorder
• • Self-reported suicidal ideation or severe depressive symptoms as determined by clinical assessment, triggered by score of ≥ 20 on the Center for Epidemiologic Studies Depression (CES-D)
• • Lactating, pregnant or plan to become pregnant in next 14 months
• • Positive urine toxicology for recreational drugs of abuse; alcohol or substance use disorder as determined by Alcohol Use Disorders Identification Test, Adapted for Use in the United States (USAUDIT294) and/or Structured Clinical Interview (SCID)
• • Daily smoker/nicotine user
• • Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the patient's full compliance with or completion of the study