The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

Breast Cancer Clinical Trial

— COIN  

Official title:

The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780814
• Other study ID #: IRB00376235
• Secondary ID: R01CA281220
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Janelle Wilder Coughlin, PHD
• Phone: (410) 550-7000
• Email: jwilder3[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior to a sleep education control (EDU) condition followed by behavioral weight loss (EDU+BWL). The investigators will measure outcomes at baseline, 8 weeks (after completing CBT-I or EDU and prior to BWL), and at 3, 6, and 12 months.

Description:

The entire study will span a 14-month period and involves one video screening visit (V1) and 4 in-person assessment visits (V2-V5) and 27 video sessions (6 for sleep intervention or sleep control and 19 for BWL). After passing an initial phone screen, participants will be scheduled for in-depth screening (V1). The investigators will complete urine samples for pregnancy and substances, administer study measures, obtain weight, height, anthropometrics and randomize at in-person visit (V2). The overall framework of the BWL intervention is social cognitive theory (increasing self-efficacy and social support) with motivational interviewing (MI) as an approach to helping participants engage in established behavior change strategies (e.g. self-monitoring, stimulus control, goal setting, feedback, etc.) aimed at reducing dietary intake and increasing physical activity (PA). Body composition will be assessed by Dual Energy X-Ray Absorptiometry (DEXA), which measures total and regional fat, lean tissue and bone mass. The investigators will conduct DEXA scans at two time points (V1 & V5).The investigators' primary endpoint is % total weight loss (TWL) at 12 months. The investigators will measure weight in light clothes without shoes, using a digital scale and height to the nearest 0.1 cm using a calibrated stadiometer, according to standardized procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Current BMI = 25 kg/m2 and weight = 400 lbs

• Willing to lose 10% of body weight

• Diagnosed within 10 years with histologically-confirmed DCIS or stage I-III invasive carcinoma of the breast

• Completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy/immunotherapy(/HER2) human epidermal growth factor receptor 2 therapy/targeted therapy at least 3months prior to enrollment (concomitant endocrine therapy allowed)

• Completed all planned/elective surgeries >4 weeks before enrollment

• Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia disorder

• Self-reported initial sleep onset time and/or wake after sleep onset (WASO) time > 30 minutes, > 3 nights/week

• Reports sleep problems present for = 3 months

• Insomnia Severity Index Score = 9

Exclusion Criteria:

• Serious/uncontrolled medical or psychiatric condition likely to hinder participation in BWL or CBT-l (bipolar disorder, psychotic disorder, seizure disorders, autoimmune disease, etc.)

• Current use of medications that cause sleep disturbances or weight gain/loss. (-) Current sedative hypnotic use

• Sleep disorder other than insomnia (mild sleep apnea or moderate to severe sleep apnea successfully treated via positive airway pressure (PAP) therapy is permitted

• Currently enrolled or planning to enroll in a sleep treatment or weight loss program (agree not to enroll for the duration of the study) (-) Home sleep test Apnea/hypopnea Index (AHI) > 15

• Participants also agree not to enroll in such a program for the duration of study participation (regardless of randomization).

• History of unstable psychiatric disorder

• Self-reported suicidal ideation or severe depressive symptoms as determined by clinical assessment, triggered by score of = 20 on the Center for Epidemiologic Studies Depression (CES-D)

• Lactating, pregnant or plan to become pregnant in next 14 months

• Positive urine toxicology for recreational drugs of abuse; alcohol or substance use disorder as determined by Alcohol Use Disorders Identification Test, Adapted for Use in the United States (USAUDIT294) and/or Structured Clinical Interview (SCID)

• Daily smoker/nicotine user

• Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the patient's full compliance with or completion of the study

Related Conditions & MeSH terms

• Body Weight
• Breast Cancer
• Breast Neoplasms
• Insomnia
• Sleep Initiation and Maintenance Disorders
• Weight Gain
• Weight Loss

Intervention

Behavioral:
• Cognitive-Behavioral Therapy for Insomnia (CBT-I)
The CBT-I intervention is a 6-session intervention spread out over 8 weeks that combines education and behavioral techniques to reduce insomnia.
• Sleep Education Control (EDU)
Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins	Baltimore	Maryland
United States	Johns Hopkins Kimmel Cancer Center at Greenspring Station	Lutherville	Maryland
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight (pounds)	Our primary endpoint is % total weight loss (TWL) at 12 months. We will measure weight in light clothes without shoes, using a digital scale (in pounds) and height to the nearest 0.1 cm using a calibrated stadiometer, according to standardized procedures.	Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.
Secondary	Diet quality as assessed by Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool	Will be measured using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, which follows an automated multiple-pass methodology.	Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.
Secondary	Physical activity assessed by wearing and accelerometer to track movement.	Accelerometers (ActiGraph, LLC, Fort Walton Beach, FL) will be used to assess both sedentary time and moderate to vigorous physical activity.	Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.
Secondary	Body composition measured through DEXA scan	Body composition will be assessed by dual energy x-ray absorptiometry (DEXA), which measures total and regional fat, lean tissue and bone mass	Baseline and week 61