Cancer, Obesity/Overweight and Insomnia Study

NCT03542604 | Completed

• 2 other identifiers: J17120IRB00132883
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Overweight and Obesity; Insomnia

Outcome Measures

Primary Outcomes (1)

• Percent Weight loss

  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.

  Change from Baseline, 8 weeks, 3 months and 6 months

Secondary Outcomes (4)

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

  Change from Baseline, 8 weeks, 3 months and 6 months

• Sleep continuity as measured by total sleep time (TST)

  Change from Baseline, 8 weeks, 3 months and 6 months

• Sleep continuity as measured by sleep efficiency (SE)

  Change from Baseline, 8 weeks, 3 months and 6 months

• Sleep continuity as measured by sleep latency (SL)

  Change from Baseline, 8 weeks, 3 months and 6 months

Study Arms (2)

CBT-I + BWL

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy for Insomnia

EDU + BWL

PLACEBO COMPARATOR

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.

Behavioral: Sleep Education

Interventions

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.

CBT-I + BWL

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.

EDU + BWL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Under Armour, Inc.: collaborator

Study Sites (1)

Johns Hopkins University, Bayview Medical Campus

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Overweight; Obesity; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Janelle Coughlin, Ph.D.

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will not be blinded to the intervention assignment. However, data collection of anthropometric measurements (including height, weight, hip and waist circumference) will be done by a study member blinded to the randomization. Since participants will be aware of their intervention assignment, there are no anticipated circumstances for breaking the blinding or planned procedures for breaking the blinding.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 30 participants will be randomized to either cognitive-behavioral treatment for insomnia with behavioral weight loss (CBT-I+BWL) or a sleep education control condition with behavioral weight loss (EDU+BWL). The EDU group will have study sessions spread out in a similar fashion to the CBT-I group, and clinical outcomes will be compared between groups 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.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: May 31, 2018
• Study Start: June 12, 2018
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

US (1)