Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heather Greenlee, Columbia University
ClinicalTrials.gov Identifier:
NCT00811824
First received: December 18, 2008
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

This study is testing the effects of exercise and dietary change on weight reduction and biological markers associated with breast cancer risk in breast cancer survivors of Hispanic or African descent (n=45). This is a randomized, crossover pilot and feasibility study to test the effects of a 30-minute circuit-based exercise program that combines resistance training with aerobic exercise in conjunction with a low-fat calorie reduced diet. Participants will be randomized to either an immediate 6-months of exercise and dietary change, or a delayed group who will begin their exercise and dietary change program 6-months after the study begins. Participants in the immediate group will be followed for an additional 6-months in order to evaluate adherence to the exercise and dietary change recommendations. Participants in both groups will exercise at a neighborhood Curves® facility at least 5 times per week for six months and will participate in a series of nutrition education classes.


Condition Intervention Phase
Breast Cancer
Behavioral: Physical activity and dietary change
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in weight [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Intervention adherence [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Barriers to participation [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Predictors of adherence [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Changes in anthropometric measures [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Changes in fitness [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Changes in hormonal biomarkers [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Changes in metabolic markers [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Changes in psychological and quality of life measures [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: July 2007
Study Completion Date: November 2012
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Immediate physical activity and dietary change intervention
Behavioral: Physical activity and dietary change
6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class
2
Delayed physical activity and dietary change intervention
Behavioral: Physical activity and dietary change
6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 21-70 yrs
  • Stage 0-IIIa breast cancer
  • No evidence of recurrent/metastatic disease
  • Hispanic or African descent (African-American or Caribbean)
  • BMI > 25kg/m2
  • Sedentary
  • Completed surgery, chemotherapy, and radiation therapy ≥ 6 months
  • Blood pressure < 140/90
  • HgbA1C < 8
  • LDL cholesterol < 150
  • No uncontrolled comorbidities
  • VO2 max normal EKG changes
  • Non-smoker

Exclusion Criteria:

  • Evidence of recurrent or metastatic breast cancer
  • Uncontrolled co-morbid illness including, but not limited to, type I diabetes mellitus, type II diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary disease; hypercholesterolemia, neurological condition, ischemic heart disease, cardiac disease, kidney disease, respiration problems, asthma, shortness of breath, physical limitations, abnormal thyroid function, active malignancy, except for squamous or basal cell carcinoma of the skin; receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements
  • Currently taking Herceptin therapy, or abnormal echo or MUGA post-Herceptin therapy
  • Active tobacco use
  • Currently active in an exercise and/or dietary change weight loss program
  • If a participant develops a breast cancer recurrence or metastasis during the 12-month study period, her participation in the study will be terminated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811824

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Heather Greenlee, ND, PhD Columbia University
  More Information

No publications provided

Responsible Party: Heather Greenlee, Assistant Professor, Department of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT00811824     History of Changes
Other Study ID Numbers: AAAB8839
Study First Received: December 18, 2008
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Weight loss
Physical activity
Dietary change

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 29, 2014