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Completed

NCT Number: NCT03542604

Cancer, Obesity/Overweight and Insomnia Study

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.

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Key information

Conditions

Breast Cancer Body Weight Breast Diseases Breast Neoplasms Dyssomnias Insomnia Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University, Bayview Medical Campus

Baltimore, Maryland, 21224, United States

About this study

Participants are women with a diagnosis of early stage breast cancer (ESBC), a BMI ≥25, and insomnia. A total of 30 participants will be randomized to either cognitive behavioral therapy for insomnia and behavioral weight loss (CBT-I+BWL) or a sleep education program and behavioral weight loss (EDU+BWL). Measures will be collected at baseline, 8 weeks (after the CBT-I or EDU program) and at 3 and 6 months after starting BWL. The primary outcome will be % total weight loss. Additionally, eating behaviors, physical activity, and sleep parameters will be carefully assessed.

The sleep intervention phase of the study includes 6 sessions over 8 weeks (2 in-person, followed by 4 phone or videoconferencing sessions), and the BWL intervention includes 15 sessions over 6 months (1 in-person, 14 by phone or videoconference). Participants will be given physical activity trackers and will use a dietary app to record their food intake. There are 4 in-person assessment visits (baseline/randomization, 8-week follow up, 3-month follow up, 6-month follow up). These assessment visits are coordinated with in-person sleep and weight loss intervention visits. Some of the measures that will be recorded throughout the study include: height, weight, anthropometric measures (waist/hip measurements), sleep diaries, and self-report measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

CBT-I involves identifying and replacing thoughts and behaviors that cause or worsen sleep problems with habits that promote sound sleep. There will be 6 intervention sessions over an 8-week period. The first two sessions are consecutive weekly in-person sessions followed by a rest week. The third session is conducted remotely by phone, followed by another rest week. The three remaining sessions are weekly and conducted remotely.

Sleep Education

Behavioral

EDU involves learning behavioral treatment information about sleep that is widely available to patients and practitioners. The program will parallel the CBT-I intervention in schedule, number, and length of sessions.

Primary outcomes

  1. Percent Weight loss

    Time frame: Change from Baseline, 8 weeks, 3 months and 6 months

    The primary outcome will be percent (%) weight loss. All subjects who are randomized will be included in the analysis of the primary outcome. Weight will be measured according to standardized BMI and anthropometric procedures (hip/waist ratio). For the primary aim, comparing the effects of CBT-I+BWL and EDU+BWL on % weight loss at 3 and 6 months, we will model outcomes (at 3 months & 6 mos.) as a function of baseline level, treatment assignment, time, and their interaction. The interaction term represents the between-group difference in change over time on the outcome.

Secondary outcomes

  1. Sleep continuity as measured by wake after sleep onset (WASO)

    Time frame: Change from Baseline, 8 weeks, 3 months and 6 months

    WASO will be measured in minutes. Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months. For this aim, evaluating the extent to which short-term sleep continuity improvements (8 wk and 3 mo) are associated with improvements in daily physical activity and dietary quality/quantity and determining their association with 3- and 6-month weight changes, we will model between-group differences in the short-term trajectory of change for the primary sleep continuity measures, actigraphy TST and WASO.

  2. Sleep continuity as measured by total sleep time (TST)

    Time frame: Change from Baseline, 8 weeks, 3 months and 6 months

    TST will be measured in minutes. Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months. For this aim, evaluating the extent to which short-term sleep continuity improvements (8 wk and 3 mo) are associated with improvements in daily physical activity and dietary quality/quantity and determining their association with 3- and 6-month weight changes, we will model between-group differences in the short-term trajectory of change for the primary sleep continuity measures, actigraphy TST and WASO.

  3. Sleep continuity as measured by sleep efficiency (SE)

    Time frame: Change from Baseline, 8 weeks, 3 months and 6 months

    Sleep efficiency is measured as the ratio of total sleep time (TST) compared to the total time spent in bed (TST / time in bed). This is measured in percent of total time spent in bed, asleep.

    Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months.

  4. Sleep continuity as measured by sleep latency (SL)

    Time frame: Change from Baseline, 8 weeks, 3 months and 6 months

    Sleep latency is the time it takes to transition from full wakefulness to sleep. This is measured in minutes. Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Under Armour, Inc.

Registry information

Official study title

The Effects of Treating Insomnia Prior to a Weight Loss Intervention in Women With Early Stage Breast Cancer

Acronym: COIN

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 31, 2018
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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