Behavioral Weight Loss and Exercise After Treatment (BEAT)

NCT02052115 | Unknown

• 2 other identifiers: VCC 13111P20GM103644-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Overweight and physically inactive breast cancer survivors are at increased risk of breast cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight loss and exercise success include the long term effects such as fatigue, psychological distress and impaired executive (cognitive) function. This study will explore the variability in how breast cancer survivors respond to a behavioral weight loss intervention. The primary objectives include determining the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function as measured with task performance at 6 and 12 months and associated brain function imaging (fMRI), collected at baseline only.Additionally, the study is designed to determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months following entry into a behavioral weight loss and exercise intervention.

Conditions

Breast Cancer

Keywords

breast cancer; exercise; weight loss; executive function; breast cancer survivor

Outcome Measures

Primary Outcomes (1)

• Correlation of executive function and weight loss success

  Determine the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function, measured with task performance and associated brain function imaging (fMRI), at 6 and 12 months.

  12 months

Secondary Outcomes (2)

• Correlation of cancer related symptoms and weight loss

  12 months

• Efficacy of a weight loss intervention

  12 months

Study Arms (1)

Exercise and weight loss

OTHER

12 month exercise and weight loss intervention

Behavioral: 12 month exercise and weight loss intervention

Interventions

12 month exercise and weight loss intervention BEHAVIORAL

Exercise and weight loss

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer diagnosis
• Received surgery +/- chemotherapy +/- radiation for treatment of a Stage I, II or III breast cancer. Ongoing treatment with monoclonal antibodies and/or anti-estrogen therapy is acceptable
• Completion of initial therapy 6 weeks prior to study initiation
• BMI of 27-45 kg/m\^2

You may not qualify if:

• Medical conditions that limit food choices such as celiac sprue or inflammatory bowel disease
• Inability to walk on flat ground (or a treadmill) at 2.5 mph for 5 minutes
• Age \<21 and \>70
• Presence of body metal
• Psychotic or central nervous system impairment that would limit compliance with study requirements, including dementia
• Evidence of metastatic disease
• Symptomatic heart disease (chest pain or equivalent with activity)
• Exercise limiting pulmonary disease or need for oxygen to exercise
• Individuals taking mood stabilizing medications including: Lithium, valproic acid, also called divalproex sodium (Depakote), carbamazepine (Tegretol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), ziprasidone (Geodon), clozapine (clorazil)
• Participants with an active neurologic disorder that affects the central nervous system, including seizures, and Parkinson's disease
• Weight loss of \>10 lbs in the previous 6 months
• Participation in \> 150 minutes of moderate intensity activity by self report, unless activity level by accelerometer is less than 150 minutes of moderate intensity activity

Sponsors & Collaborators

• University of Vermont: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Vermont Cancer Center

Burlington, Vermont, 05405, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Weight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kim Dittus, MD, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Dittus, MD, PhD

CONTACT

802-656-5470; kim.dittus@vtmednet.org

Karen Wilson, CCRP

CONTACT

802-656-4101; karen.m.wilson@uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: January 31, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

US (1)