Status:
COMPLETED
DAMES: Daughters And MothErS Against Breast Cancer
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
Primary Aim: -To explore the feasibility and acceptability of two distinctly different tailored, home-based diet and exercise interventions (one that relies on a partner-assisted, team-based approach...
Detailed Description
DAUGHTER AND MOTHER - FULL INTERVENTION STUDY: Women who are overweight have a greater chance of developing breast cancer as they get older, and also are at greater risk of developing more aggressive...
Eligibility Criteria
Inclusion
- DCIS or Stage I-IIIA Breast Cancer (MOTHERS)
- Have a biological daughter at least 21 years old (MOTHERS)
- Body Mass Index between 25 - 40 (MOTHERS) or 25 or above (DAUGHTERS)
- English Speaking \& Writing (MOTHERS \& DAUGHTERS)
- 5th grade or higher educational level (MOTHERS \& DAUGHTERS)
- Willingness to be randomized into the standardized or tailored intervention arms and to undergo baseline and follow-up assessments (MOTHERS \& DAUGHTERS)
- Must be at least 21 years of age (MOTHERS \& DAUGHTERS)
- Must reside within the United States, Puerto Rico or Guam and therefore able to participate in home visits made by Examination Management Services, Inc. (MOTHERS \& DAUGHTERS)
Exclusion
- Evidence of progressive breast cancer or 2nd primaries (MOTHERS)
- Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program or to a diet high in fruits and vegetables, such as the following: untreated stage 3 hypertension; severe orthopedic conditions; scheduled for a hip or knee replacement within 6 months; paralysis; end-stage renal disease; dementia; unstable angina; heart attack, congestive heart failure or pulmonary conditions that have required hospitalization or oxygen within 6 months (MOTHERS \& DAUGHTERS)
- Currently exercising 30+ minutes/day for 5+ days/week (\<150 minutes per week) (MOTHERS \& DAUGHTERS)
- Currently enrolled in a weight loss program (MOTHERS \& DAUGHTERS)
- Residing in institutionalized settings, e.g., living in assisted or skilled nursing facilities, and therefore not able to make independent choices about their lifestyle behaviors and participate fully in the intervention (MOTHERS AND DAUGHTERS).
- Currently pregnant (MOTHERS \& DAUGHTERS)
- A previous diagnosis of breast cancer (DAUGHTERS).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT00630591
Start Date
February 1 2008
End Date
July 1 2010
Last Update
February 2 2017
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27708
2
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030