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The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer (COIN)

Primary Purpose

Breast Cancer, Insomnia, Weight Gain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Sleep Education Control (EDU)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring women, breast cancer, weight gain, weight loss, insomnia, sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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 prior to enrollment (concomitant endocrine therapy allowed) 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 Exclusion Criteria: 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 Structured Clinical Interview (SCID) 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

Sites / Locations

  • Sibley Memorial Hospital
  • Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
  • Johns Hopkins Bayview
  • Johns Hopkins Kimmel Cancer Center at Greenspring Station

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Sleep Education Control (EDU)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
March 9, 2023
Last Updated
October 19, 2023
Sponsor
Johns Hopkins University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05780814
Brief Title
The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
Acronym
COIN
Official Title
The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The entire study will span a 14-month period and involves one video screening visit (V1) and 4 in-person assessment visits (V2-V5) and 27 video sessions (6 for sleep intervention or sleep control and 19 for BWL). After passing an initial phone screen, participants will be scheduled for in-depth screening (V1). The investigators will complete urine samples for pregnancy and substances, administer study measures, obtain weight, height, anthropometrics and randomize at in-person visit (V2). The overall framework of the BWL intervention is social cognitive theory (increasing self-efficacy and social support) with motivational interviewing (MI) as an approach to helping participants engage in established behavior change strategies (e.g. self-monitoring, stimulus control, goal setting, feedback, etc.) aimed at reducing dietary intake and increasing physical activity (PA). Body composition will be assessed by Dual Energy X-Ray Absorptiometry (DEXA), which measures total and regional fat, lean tissue and bone mass. The investigators will conduct DEXA scans at two time points (V1 & V5).The investigators' primary endpoint is % total weight loss (TWL) at 12 months. The investigators will measure weight in light clothes without shoes, using a digital scale and height to the nearest 0.1 cm using a calibrated stadiometer, according to standardized procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Insomnia, Weight Gain
Keywords
women, breast cancer, weight gain, weight loss, insomnia, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Arm Type
Experimental
Arm Description
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.
Arm Title
Sleep Education Control (EDU)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Intervention Description
The CBT-I intervention is a 6-session intervention spread out over 8 weeks that combines education and behavioral techniques to reduce insomnia.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Education Control (EDU)
Intervention Description
Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine
Primary Outcome Measure Information:
Title
Change in Weight (pounds)
Description
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 Outcome Measure Information:
Title
Diet quality as assessed by Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool
Description
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.
Title
Physical activity assessed by wearing and accelerometer to track movement.
Description
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.
Title
Body composition measured through DEXA scan
Description
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 61

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Assigned female at birth
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 prior to enrollment (concomitant endocrine therapy allowed) 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 Exclusion Criteria: 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 Structured Clinical Interview (SCID) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janelle Wilder Coughlin, PHD
Phone
(410) 550-7000
Email
jwilder3@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Smith, BA
Phone
(410) 550-8099
Email
ksmit261@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janelle Wilder Coughlin, PHD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Smith, PHD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Smith, BA
Phone
410-550-8099
Email
ksmit261@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Janelle Wilder Coughlin, PHD
First Name & Middle Initial & Last Name & Degree
Michael Smith, PHD
Facility Name
Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Smith, BA
Phone
410-550-8099
Email
ksmit261@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Janelle Wilder Coughlin, PHD
First Name & Middle Initial & Last Name & Degree
Michael Smith, PHD
Facility Name
Johns Hopkins Bayview
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Smith, BA
Phone
410-550-8099
Email
ksmit261@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Janelle Wilder Coughlin, PHD
First Name & Middle Initial & Last Name & Degree
Michael Smith, PHD
Facility Name
Johns Hopkins Kimmel Cancer Center at Greenspring Station
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Smith, BA
Phone
410-550-8099
Email
ksmit261@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Janelle Wilder Coughlin, PHD
First Name & Middle Initial & Last Name & Degree
Michael Smith, PHD

12. IPD Sharing Statement

Learn more about this trial

The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

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