Cancer, Obesity/Overweight and Insomnia Study

NCT ID: NCT03542604

Last Updated: 2020-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2020-11-30

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.

Conditions

Breast Cancer; Overweight and Obesity; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

CBT-I + BWL

Cognitive behavioral therapy intervention for insomnia: 6 sessions over 8-week period combining education and behavioral techniques to reduce insomnia. Sleep intervention followed by behavioral weight loss intervention.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

CBT-I involves identifying and replacing thoughts and behaviors that cause or worsen sleep problems with habits that promote sound sleep. There will be 6 intervention sessions over an 8-week period. The first two sessions are consecutive weekly in-person sessions followed by a rest week. The third session is conducted remotely by phone, followed by another rest week. The three remaining sessions are weekly and conducted remotely.

EDU + BWL

Program will parallel the CBT-I intervention in number and length of sessions. Intended to disseminate basic information about sleep, including behavioral treatment information that is widely available to patients and practitioners.Will be followed by behavioral weight loss intervention.

Group Type: PLACEBO_COMPARATOR

Sleep Education

Intervention Type: BEHAVIORAL

EDU involves learning behavioral treatment information about sleep that is widely available to patients and practitioners. The program will parallel the CBT-I intervention in schedule, number, and length of sessions.

Interventions

Cognitive Behavioral Therapy for Insomnia

CBT-I involves identifying and replacing thoughts and behaviors that cause or worsen sleep problems with habits that promote sound sleep. There will be 6 intervention sessions over an 8-week period. The first two sessions are consecutive weekly in-person sessions followed by a rest week. The third session is conducted remotely by phone, followed by another rest week. The three remaining sessions are weekly and conducted remotely.

Intervention Type: BEHAVIORAL

Sleep Education

EDU involves learning behavioral treatment information about sleep that is widely available to patients and practitioners. The program will parallel the CBT-I intervention in schedule, number, and length of sessions.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Under Armour, Inc.

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janelle Coughlin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Johns Hopkins University, Bayview Medical Campus

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00132883

Identifier Type: OTHER

Identifier Source: secondary_id

J17120

Identifier Type: -

Identifier Source: org_study_id