Clinical trial · Interventional
Cancer, Obesity/Overweight and Insomnia Study
The Effects of Treating Insomnia Prior to a Weight Loss Intervention in Women With Early Stage Breast Cancer
NCT03542604CI-TRIAL-00048864COINcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized pilot study to better understand the relationships among insomnia, weight loss, and breast cancer. This study will assess the effectiveness of a sleep intervention prior to a web- and phone-based weight loss program.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Insomnia | — | UNRESOLVED | — |
| Overweight and Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | — | UNRESOLVED |
| Sleep Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CBT-I + BWL
- description
- Cognitive behavioral therapy intervention for insomnia: 6 sessions over 8-week period combining education and behavioral techniques to reduce insomnia. Sleep intervention followed by behavioral weight loss intervention.
- interventionNames
- Behavioral: Cognitive Behavioral Therapy for Insomnia
- type
- PLACEBO_COMPARATOR
- label
- EDU + BWL
- description
- Program will parallel the CBT-I intervention in number and length of sessions. Intended to disseminate basic information about sleep, including behavioral treatment information that is widely available to patients and practitioners.Will be followed by behavioral weight loss intervention.
- interventionNames
- Behavioral: Sleep Education
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs * Willing to lose 10% of body weight * Diagnosed with current breast cancer \>3 and \<60 months from planned baseline visit date * Completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy within \>3 prior to enrollment * Diagnosed with insomnia or reports sleep problems * Has daily access to the internet and/or smartphone Exclusion Criteria: * Serious/uncontrolled condition likely to hinder accurate measurement of weight or sleep, such as bipolar I, seizure disorders, autoimmune disease, etc., or a medical condition that makes physical activity unsafe * Current use of weight loss medications or sleeping aids * Current enrollment in a sleep or weight loss program * Sleep disorder other than insomnia * Plan to become pregnant within next 12 months, or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.