Trial Title:
The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
NCT ID:
NCT05780814
Condition:
Breast Cancer
Insomnia
Weight Gain
Conditions: Official terms:
Breast Neoplasms
Sleep Initiation and Maintenance Disorders
Body Weight
Weight Loss
Weight Gain
Conditions: Keywords:
women
breast cancer
weight gain
weight loss
insomnia
sleep
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Care Provider, Investigator)
Intervention:
Intervention type:
Behavioral
Intervention name:
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Description:
The CBT-I intervention is a 6-session intervention spread out over 8 weeks that combines
education and behavioral techniques to reduce insomnia.
Arm group label:
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Intervention type:
Behavioral
Intervention name:
Sleep Education Control (EDU)
Description:
Subjects will be instructed to read and review select publications from the American
Academy of Sleep Medicine
Arm group label:
Sleep Education Control (EDU)
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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Gender description:
Assigned female at birth
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sibley Memorial Hospital
Address:
City:
Washington
Zip:
20016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katie Smith, BA
Phone:
410-550-8099
Email:
ksmit261@jhmi.edu
Investigator:
Last name:
Janelle Wilder Coughlin, PHD
Email:
Principal Investigator
Investigator:
Last name:
Michael Smith, PHD
Email:
Principal Investigator
Facility:
Name:
Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
Address:
City:
Baltimore
Zip:
21218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katie Smith, BA
Phone:
410-550-8099
Email:
ksmit261@jhmi.edu
Investigator:
Last name:
Janelle Wilder Coughlin, PHD
Email:
Principal Investigator
Investigator:
Last name:
Michael Smith, PHD
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins Bayview
Address:
City:
Baltimore
Zip:
21224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katie Smith, BA
Phone:
410-550-8099
Email:
ksmit261@jhmi.edu
Investigator:
Last name:
Janelle Wilder Coughlin, PHD
Email:
Principal Investigator
Investigator:
Last name:
Michael Smith, PHD
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins Kimmel Cancer Center at Greenspring Station
Address:
City:
Lutherville
Zip:
21093
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katie Smith, BA
Phone:
410-550-8099
Email:
ksmit261@jhmi.edu
Investigator:
Last name:
Janelle Wilder Coughlin, PHD
Email:
Principal Investigator
Investigator:
Last name:
Michael Smith, PHD
Email:
Principal Investigator
Start date:
February 1, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Johns Hopkins University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Johns Hopkins University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05780814
