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

NCT ID: NCT05780814

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2028-12-31

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.

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.

Conditions

Breast Cancer; Insomnia; Weight Gain

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Intervention Type: BEHAVIORAL

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)

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.

Group Type: PLACEBO_COMPARATOR

Sleep Education Control (EDU)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Sleep Education Control (EDU)

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

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
• 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

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janelle Wilder Coughlin, PHD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Michael Smith, PHD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status: RECRUITING

Johns Hopkins Bayview

Baltimore, Maryland, United States

Site Status: RECRUITING

Johns Hopkins Kimmel Cancer Center at Greenspring Station

Lutherville, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Janelle Wilder Coughlin, PHD

Role: CONTACT

jwilder3@jhmi.edu

(410) 550-7000

Katie Smith, BA

Role: CONTACT

ksmit261@jhmi.edu

(410) 550-8099

Facility Contacts

Katie Smith, BA

Role: primary

ksmit261@jhmi.edu

410-550-8099

Katie Smith, BA

Role: primary

ksmit261@jhmi.edu

410-550-8099

Katie Smith, BA

Role: primary

ksmit261@jhmi.edu

410-550-8099

Katie Smith, BA

Role: primary

ksmit261@jhmi.edu

410-550-8099

Other Identifiers

R01CA281220

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00376235

Identifier Type: -

Identifier Source: org_study_id