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

Primary Purpose

Weight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet and exercise
Sponsored by
Baptist Health South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight focused on measuring BMI, Lipid profile

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • South Miami Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diet and Exercise

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Lipid Profiles, hemoglobin A1C
To assess the impact of such intervention on lipid profiles and hemoglobin A1C. The study group will be compared with a historical control group of patients with early stage breast cancer who are obese or overweight who were not given the intervention and to examine whether an active intervention program will lead into longstanding lifestyle modification in breast cancer patients with a BMI greater or equal to 25.

Full Information

First Posted
July 16, 2013
Last Updated
July 20, 2016
Sponsor
Baptist Health South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02037542
Brief Title
A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
Official Title
A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baptist Health South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Primary endpoint: 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. Secondary endpoint: To assess the impact of such intervention on lipid profiles and hemoglobin A1C. The study group will be compared with a historical control group of patients with early stage breast cancer who are obese or overweight who were not given the intervention Secondary endpoint: To examine whether an active intervention program will lead into longstanding lifestyle modification in breast cancer patients with a BMI greater or equal to 25.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight
Keywords
BMI, Lipid profile

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet and Exercise
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Diet and exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lifestyle intervention
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Lipid Profiles, hemoglobin A1C
Description
To assess the impact of such intervention on lipid profiles and hemoglobin A1C. The study group will be compared with a historical control group of patients with early stage breast cancer who are obese or overweight who were not given the intervention and to examine whether an active intervention program will lead into longstanding lifestyle modification in breast cancer patients with a BMI greater or equal to 25.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Amelia Rodrigues, MD
Organizational Affiliation
BHSF
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
14519753
Citation
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.
Results Reference
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PubMed Identifier
22117660
Citation
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.
Results Reference
background
PubMed Identifier
22614994
Citation
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.
Results Reference
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A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer

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