Cancer, Obesity/Overweight and Insomnia Study

Completed · Not applicable

Conditions studied: Breast Cancer, Overweight and Obesity, Insomnia

In brief

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.

Key facts

Study ID

NCT03542604

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

30

Starts

2018-06-12

Expected to finish

2020-11-30

Last updated by the study team

2020-12-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University, Bayview Medical Campus — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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