The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
BehavioralThe 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)
BehavioralSubjects will be instructed to read and review select publications from the American Academy of Sleep Medicine
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Cognitive-Behavioral Therapy for Insomnia (CBT-I)Experimental treatment 1 intervention
Group B: Sleep Education Control (EDU)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.Secondary outcomes
1
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.
Time frame
Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.2
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.
Time frame
Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.3
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
Time frame
Baseline and week 61Sponsors and contacts
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Johns Hopkins University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov