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

Sponsor

Johns Hopkins University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05780814

Collaborator

National Institutes of Health (NIH) (NIH)

250

Enrollment

Locations

Arms

Anticipated Duration (Months)

62.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Insomnia Weight Gain	Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBT-I) Behavioral: Sleep Education Control (EDU)	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive-Behavioral Therapy for Insomnia (CBT-I) The proposed intervention consists of 6 remotely-delivered sessions; Weeks 1, 2, 4, 6, 7, and 8, with weeks 3 and 5 being "rest weeks". Session 1 will be 60-90 mins, Session 2 will be ~60 mins, and remaining visits are ~45 mins. The investigators propose a methodological innovation for CBT-I, which involves conducting 15-minute sessions every other month during the BWL intervention. Prior to these maintenance sessions, participants in the CBT-I+BWL group will complete electronic sleep diaries for one week and interventionists will use this information in sessions to sustain and enhance long-term outcomes by using MI to reinforce application of CBT-I session content.	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.
Placebo Comparator: Sleep Education Control (EDU) The EDU intervention will parallel the CBT-I intervention in number, format and length of all sessions, including maintenance sessions. It provides basic information about sleep and cancer, widely available to the public. EDU content does not include any individualized behavioral instructions, sleep diary monitoring during the intervention, or behavior change counseling. Content is presented didactically only.	Behavioral: Sleep Education Control (EDU) Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine

Arm

Intervention/Treatment

Experimental: Cognitive-Behavioral Therapy for Insomnia (CBT-I)

The proposed intervention consists of 6 remotely-delivered sessions; Weeks 1, 2, 4, 6, 7, and 8, with weeks 3 and 5 being "rest weeks". Session 1 will be 60-90 mins, Session 2 will be ~60 mins, and remaining visits are ~45 mins. The investigators propose a methodological innovation for CBT-I, which involves conducting 15-minute sessions every other month during the BWL intervention. Prior to these maintenance sessions, participants in the CBT-I+BWL group will complete electronic sleep diaries for one week and interventionists will use this information in sessions to sustain and enhance long-term outcomes by using MI to reinforce application of CBT-I session content.

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.

Placebo Comparator: Sleep Education Control (EDU)

The EDU intervention will parallel the CBT-I intervention in number, format and length of all sessions, including maintenance sessions. It provides basic information about sleep and cancer, widely available to the public. EDU content does not include any individualized behavioral instructions, sleep diary monitoring during the intervention, or behavior change counseling. Content is presented didactically only.

Behavioral: Sleep Education Control (EDU)

Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine

Outcome Measures

Primary Outcome Measures

Change in Weight (pounds) [Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.]
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.

Secondary Outcome Measures

Diet quality as assessed by Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool [Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.]
Will be measured using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, which follows an automated multiple-pass methodology.
Physical activity assessed by wearing and accelerometer to track movement. [Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.]
Accelerometers (ActiGraph, LLC, Fort Walton Beach, FL) will be used to assess both sedentary time and moderate to vigorous physical activity.
Body composition measured through DEXA scan [Baseline and week 61]
Body composition will be assessed by dual energy x-ray absorptiometry (DEXA), which measures total and regional fat, lean tissue and bone mass

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sibley Memorial Hospital	Washington	District of Columbia	United States	20016
2	Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins	Baltimore	Maryland	United States	21218
3	Johns Hopkins Bayview	Baltimore	Maryland	United States	21224
4	Johns Hopkins Kimmel Cancer Center at Greenspring Station	Lutherville	Maryland	United States	21093