Clinical trial for Breast Cancer
Official title The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
ClinicalTrials.gov ID: NCT05780814
What this study is testing
- What it's testing
- The study wants to see whether treating insomnia first improves weight‑loss results in women who had early‑stage breast cancer and are overweight or obese.
- Who it's for
- Women who have survived early‑stage breast cancer, are overweight or obese, and have trouble sleeping.
- What's involved
- Participants will first receive either a brief cognitive‑behavioral sleep program or a sleep‑education talk, then both groups will take part in a weight‑loss program. They will have visits and tests at several time points.
- Time commitment
- The study lasts about a year, with visits at baseline, 8 weeks, and at 3, 6, and 12 months.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- Serious/uncontrolled medical or psychiatric condition likely to hinder participation in BWL or CBT-l (bipolar disorder, psychotic disorder, seizure...
- 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)...
- 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...
- Participants also agree not to enroll in such a program for the duration of study participation (regardless of randomization).
- History of unstable psychiatric disorder
See the full eligibility 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Washington D.C., District of Columbia, United States
- Baltimore, Maryland, United States
- Lutherville, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States; Lutherville, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.