the effects of treating insomnia on behavioral weight loss outcomes in survivors of breast cancer

Conditions: Breast Cancer; Insomnia; Weight Gain

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.

the entire study will span a 14-month period and involves one video screening visit (v1) and 4 in-person assessment visits (v2-v5) and 27 video sessions (6 for sleep intervention or sleep control and 19 for bwl). after passing an initial phone screen, participants will be scheduled for in-depth screening (v1). the investigators will complete urine samples for pregnancy and substances, administer study measures, obtain weight, height, anthropometrics and randomize at in-person visit (v2). the overall framework of the bwl intervention is social cognitive theory (increasing self-efficacy and social support) with motivational interviewing (mi) as an approach to helping participants engage in established behavior change strategies (e.g. self-monitoring, stimulus control, goal setting, feedback, etc.) aimed at reducing dietary intake and increasing physical activity (pa). body composition will be assessed by dual energy x-ray absorptiometry (dexa), which measures total and regional fat, lean tissue and bone mass. the investigators will conduct dexa scans at two time points (v1 \& v5).the investigators' primary endpoint is % total weight loss (twl) at 12 months. the investigators will measure weight in light clothes without shoes, using a digital scale and height to the nearest 0.1 cm using a calibrated stadiometer, according to standardized procedures.

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

Keywords: women breast cancer weight gain weight loss insomnia sleep