Clinical trial NCT03542604: Cancer, Obesity/Overweight and Insomnia Study
Official title: The Effects of Treating Insomnia Prior to a Weight Loss Intervention in Women With Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Overweight and Obesity
Insomnia
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Under Armour, Inc.
First posted: 2018-05-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 30 participants will be randomized to either cognitive-behavioral treatment for insomnia with behavioral weight loss (CBT-I+BWL) or a sleep education control condition with behavioral weight loss (EDU+BWL). The EDU group will have study sessions spread out in a similar fashion to the CBT-I group, and clinical outcomes will be compared between groups 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.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

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
* 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

Primary outcomes:
measure: Percent Weight loss
timeFrame: Change from Baseline, 8 weeks, 3 months and 6 months
Secondary outcomes:
measure: Sleep continuity as measured by wake after sleep onset (WASO)
timeFrame: Change from Baseline, 8 weeks, 3 months and 6 months
measure: Sleep continuity as measured by total sleep time (TST)
timeFrame: Change from Baseline, 8 weeks, 3 months and 6 months
measure: Sleep continuity as measured by sleep efficiency (SE)
timeFrame: Change from Baseline, 8 weeks, 3 months and 6 months
measure: Sleep continuity as measured by sleep latency (SL)
timeFrame: Change from Baseline, 8 weeks, 3 months and 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University, Bayview Medical Campus
state: Maryland
Study officials:
affiliation: Associate Professor
name: Janelle Coughlin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: