A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer

NCT02037542 | Completed

• 1 other identifier: 072013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the hypothesis that an intervention of lifestyle modification will positively impact women with breast cancer who are overweight and/or obese. To that end, our primary endpoint is to examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.

Conditions

Weight

Keywords

BMI, Lipid profile

Outcome Measures

Primary Outcomes (1)

• Lifestyle intervention

  To examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.

  One year

Secondary Outcomes (1)

• Lipid Profiles, hemoglobin A1C

  1 year

Study Arms (1)

Diet and Exercise

EXPERIMENTAL

Prospective, observational, cohort study, with a proposed start date of May 2013 and proposed end date of June 2018. Our goal is to gather data on a total of 200 patients: 100 patients (study group) will be prospectively enrolled, while data on another 100 patients (control) will be accessed through retrospective data collection. Number of patients to be analyzed will depend on enrollment and patient compliance. We would like to enroll the proposed 100 patients in the first 1-3 years of the study (approximately 30 per year).

Behavioral: Diet and exercise

Interventions

Diet and exercise BEHAVIORAL

Upon enrollment, the patient will be asked to meet with a dietitian to assess the individual patient's current diet and exercise routines. In the first session, the dietitian will provide individual counseling and together with the patient devise weight loss / exercise strategies that fit the patients' lifestyle. Following the initial assessment, patients will embark on a weekly program, with weekly meetings lasting 30min - 1h. Patients will be asked to record meal portions weekly in a Food Log (Appendix B), according to the established goal. At each meeting, the dietitian will review the Food Log with the patient and evaluate progress.

Diet and Exercise

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DCIS
• Women with stage 0 - III breast cancer (histologic type ductal or lobular)
• BMI \>=25
• Patients must have completed all chemotherapy
• Patients may be on hormonal therapy or radiation therapy
• Age \>= 18 years old to 89 Years old
• Patient must be medically stable and without significant impairments that would preclude following the proposed intervention regimen.
• Time of diagnosis: patients enrolled are within 1 month to 18 months post-diagnosis.

You may not qualify if:

• Metastatic breast cancer patients and patients with inoperable or active loco-regional disease.
• Patients following alternative/complementary diets or taking high dose antioxidant supplements.
• Patients with a physical/psychiatric impairment that would seriously impair their physical mobility.
• Patients who are currently suffering from severe nausea, anorexia or other diseases affecting health (e.g. arthritis and multiple sclerosis).
• Patients younger than 18 and older than 89 years.

Sponsors & Collaborators

• Baptist Health South Florida: lead

Study Sites (1)

South Miami Hospital

Miami, Florida, 33143, United States

Location

Related Publications (3)

• Dignam JJ, Wieand K, Johnson KA, Fisher B, Xu L, Mamounas EP. Obesity, tamoxifen use, and outcomes in women with estrogen receptor-positive early-stage breast cancer. J Natl Cancer Inst. 2003 Oct 1;95(19):1467-76. doi: 10.1093/jnci/djg060.

  PMID: 14519753 BACKGROUND

• Christy SM, Mosher CE, Sloane R, Snyder DC, Lobach DF, Demark-Wahnefried W. Long-term dietary outcomes of the FRESH START intervention for breast and prostate cancer survivors. J Am Diet Assoc. 2011 Dec;111(12):1844-51. doi: 10.1016/j.jada.2011.09.013.

  PMID: 22117660 BACKGROUND

• Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Miller PE, Hartman TJ, Cohen HJ. Reach out to enhance wellness home-based diet-exercise intervention promotes reproducible and sustainable long-term improvements in health behaviors, body weight, and physical functioning in older, overweight/obese cancer survivors. J Clin Oncol. 2012 Jul 1;30(19):2354-61. doi: 10.1200/JCO.2011.40.0895. Epub 2012 May 21.

  PMID: 22614994 BACKGROUND

MeSH Terms

Conditions

Body Weight

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maria Amelia Rodrigues, MD

  BHSF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Administrator

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: January 16, 2014
• Study Start: September 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 21, 2016

Record last verified: 2016-07

Locations

US (1)