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CBT for Insomnia in Breast Cancer Survivors (COIN Trial)

N/A

Recruiting

Led By Janelle Wilder Coughlin, PHD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Reports sleep problems present for ≥ 3 months

Diagnosed within 10 years with histologically-confirmed DCIS or stage I-III invasive carcinoma of the breast

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (randomization); 8 weeks post-sleep intervention (prior to bwl); and at 3, 6, and 12 months post-bwl.

Summary

This trial will compare two treatments for overweight/obese women with early stage breast cancer and insomnia: one with an insomnia intervention before weight loss, and one with sleep education before weight loss. Outcomes will be measured at various time points.

Who is the study for?

This trial is for overweight or obese female breast cancer survivors, aged 18+, who have insomnia. They must be willing to lose weight and have completed cancer treatments at least 3 months prior. Exclusions include other sleep disorders (except mild apnea), drug abuse, current smokers, or those with unstable psychiatric conditions.

What is being tested?

The study tests if Cognitive-Behavioral Therapy for Insomnia (CBT-I) enhances the effectiveness of a subsequent behavioral weight loss program compared to just receiving sleep education followed by the same weight loss program in women who've had early stage breast cancer.

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort from discussing personal issues during CBT-I sessions and typical challenges associated with lifestyle changes such as dieting and increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had trouble sleeping for 3 months or more.

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I was diagnosed with early-stage breast cancer or DCIS within the last 10 years.

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I have been diagnosed with insomnia according to DSM-5 standards.

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I am 18 years old or older.

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My BMI is 25 or higher and I weigh 400 lbs or less.

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I am female.

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My breast cancer is confirmed and not beyond stage III.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious health or mental conditions that could interfere with treatment.

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I am not taking sleep or weight affecting meds, excluding sedatives.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (randomization); 8 weeks post-sleep intervention (prior to bwl); and at 3, 6, and 12 months post-bwl.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (randomization); 8 weeks post-sleep intervention (prior to bwl); and at 3, 6, and 12 months post-bwl.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (randomization); 8 weeks post-sleep intervention (prior to bwl); and at 3, 6, and 12 months post-bwl. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Weight (pounds)

Secondary study objectives

Body composition measured through DEXA scan

Diet quality as assessed by Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool

Physical activity assessed by wearing and accelerometer to track movement.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cognitive-Behavioral Therapy for Insomnia (CBT-I)Experimental Treatment1 Intervention

The proposed intervention consists of 6 remotely-delivered sessions; Weeks 1, 2, 4, 6, 7, and 8, with weeks 3 and 5 being "rest weeks". Session 1 will be 60-90 mins, Session 2 will be \~60 mins, and remaining visits are \~45 mins. The investigators propose a methodological innovation for CBT-I, which involves conducting 15-minute sessions every other month during the BWL intervention. Prior to these maintenance sessions, participants in the CBT-I+BWL group will complete electronic sleep diaries for one week and interventionists will use this information in sessions to sustain and enhance long-term outcomes by using MI to reinforce application of CBT-I session content.

Group II: Sleep Education Control (EDU)Placebo Group1 Intervention

The EDU intervention will parallel the CBT-I intervention in number, format and length of all sessions, including maintenance sessions. It provides basic information about sleep and cancer, widely available to the public. EDU content does not include any individualized behavioral instructions, sleep diary monitoring during the intervention, or behavior change counseling. Content is presented didactically only.

0 / 10Eligibility criteria met