Cancer, Obesity/Overweight and Insomnia Study

Participants are women with a diagnosis of early stage breast cancer (ESBC), a BMI ≥25, and
insomnia. A total of 30 participants will be randomized to either cognitive behavioral
therapy for insomnia and behavioral weight loss (CBT-I+BWL) or a sleep education program and
behavioral weight loss (EDU+BWL). Measures will be collected at baseline, 8 weeks (after the
CBT-I or EDU program) and at 3 and 6 months after starting BWL. The primary outcome will be %
total weight loss. Additionally, eating behaviors, physical activity, and sleep parameters
will be carefully assessed.

The sleep intervention phase of the study includes 6 sessions over 8 weeks (2 in-person,
followed by 4 phone or videoconferencing sessions), and the BWL intervention includes 15
sessions over 6 months (1 in-person, 14 by phone or videoconference). Participants will be
given physical activity trackers and will use a dietary app to record their food intake.
There are 4 in-person assessment visits (baseline/randomization, 8-week follow up, 3-month
follow up, 6-month follow up). These assessment visits are coordinated with in-person sleep
and weight loss intervention visits. Some of the measures that will be recorded throughout
the study include: height, weight, anthropometric measures (waist/hip measurements), sleep
diaries, and self-report measures.

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

- Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs

- Willing to lose 10% of body weight

- Diagnosed with current breast cancer >3 and <60 months from planned baseline visit
date

- Completed local therapy (i.e. surgery and radiation therapy) and any planned
preoperative or adjuvant chemotherapy within >3 prior to enrollment

- Diagnosed with insomnia or reports sleep problems

- Has daily access to the internet and/or smartphone

Exclusion Criteria:

- Serious/uncontrolled condition likely to hinder accurate measurement of weight or
sleep, such as bipolar I, seizure disorders, autoimmune disease, etc., or a medical
condition that makes physical activity unsafe

- Current use of weight loss medications or sleeping aids

- Current enrollment in a sleep or weight loss program

- Sleep disorder other than insomnia

- Plan to become pregnant within next 12 months, or lactating