Baltimore, Maryland 21224

  • Insomnia

Purpose:

This is a randomized pilot study to better understand the relationships among insomnia, weight loss, and breast cancer. This study will assess the effectiveness of a sleep intervention prior to a web- and phone-based weight loss program.


Study summary:

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.


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 - 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


NCT ID:

NCT03542604


Primary Contact:

Principal Investigator
Janelle Coughlin, Ph.D.
Associate Professor


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21224
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 24, 2021

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