RECRUITING

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

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Conditions

Breast CancerInsomniaWeight Gainwomenweight losssleep

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-01
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05780814

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * 18 years of age or older
  3. * Histologically-confirmed Ductal Carcinoma In Situ (DCIS) or stage I-III invasive carcinoma of the breast
  4. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  5. * Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs
  6. * Willing to lose 10% of body weight
  7. * Diagnosed within 10 years with histologically-confirmed DCIS or stage I-III invasive carcinoma of the breast
  8. * 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)
  9. * Completed all planned/elective surgeries \>4 weeks before enrollment
  10. * Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia disorder
  11. * Self-reported initial sleep onset time and/or wake after sleep onset (WASO) time \> 30 minutes, \> 3 nights/week
  12. * Reports sleep problems present for ≥ 3 months
  13. * Insomnia Severity Index Score ≥ 9
  1. * Serious/uncontrolled medical or psychiatric condition likely to hinder participation in BWL or CBT-l (bipolar disorder, psychotic disorder, seizure disorders, autoimmune disease, etc.)
  2. * Current use of medications that cause sleep disturbances or weight gain/loss. (-) Current sedative hypnotic use
  3. * Sleep disorder other than insomnia (mild sleep apnea or moderate to severe sleep apnea successfully treated via positive airway pressure (PAP) therapy is permitted
  4. * 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
  5. * Participants also agree not to enroll in such a program for the duration of study participation (regardless of randomization).
  6. * History of unstable psychiatric disorder
  7. * 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)
  8. * Lactating, pregnant or plan to become pregnant in next 14 months
  9. * 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)
  10. * Daily smoker/nicotine user
  11. * 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

Study Contact

Janelle Wilder Coughlin, PHD
CONTACT
(410) 550-7000
jwilder3@jhmi.edu
Katie Smith, BA
CONTACT
(410) 550-8099
ksmit261@jhmi.edu

Principal Investigator

Janelle Wilder Coughlin, PHD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Michael Smith, PHD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Sibley Memorial Hospital
Washington, District of Columbia, 20016
United States
Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
Baltimore, Maryland, 21218
United States
Johns Hopkins Bayview
Baltimore, Maryland, 21224
United States
Johns Hopkins Kimmel Cancer Center at Greenspring Station
Lutherville, Maryland, 21093
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Janelle Wilder Coughlin, PHD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
  • Michael Smith, PHD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-01
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-02-01
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • women
  • breast cancer
  • weight gain
  • weight loss
  • insomnia
  • sleep

Additional Relevant MeSH Terms

  • Breast Cancer
  • Insomnia
  • Weight Gain