DAMES: Daughters And MothErS Against Breast Cancer
2 other identifiers
interventional
482
1 country
2
Brief Summary
Primary Aim:
- To explore potential effects (and variation) noted among each of the three intervention arms from baseline to 6 and 12- month follow-up on the following endpoints: BMI, energy intake and nutrient density of the diet, exercise \[min/week and metabolic equivalents (METs)\], self-efficacy to adhere to an energy restricted, plant-based, low saturated fat diet and increased exercise, blood pressure, health-related quality of life (HRQOL), social support (in general and as specifically related to healthful dietary and exercise behavior), and characteristics of the mother-daughter bond (e.g., strength). Secondary Aim:
- To explore potential mediators and moderators of healthful dietary and exercise behaviors, such as the strength of the mother-daughter bond, geographic proximity of mothers and daughters, self-efficacy for lifestyle change, etc.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Feb 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 28, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFebruary 2, 2017
July 1, 2012
2.1 years
February 28, 2008
February 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Accrual
12-Months
Study Arms (3)
Standardized Materials Group
EXPERIMENTALIndependent Tailored Intervention
EXPERIMENTALPartner-Assisted Tailored Intervention
EXPERIMENTALInterventions
7 sets of print materials will be mailed every 6-7 weeks. A short survey about the information received and how useful it was will be completed.
Personalized notebooks and newsletters of diet and exercise information will be mailed. A short survey about the information received and how useful it was will be completed.
Daughters and Mothers, as a team, will each receive personalized notebooks and newsletters of diet and exercise information. A short survey about the information received and how useful it was will be completed.
Eligibility Criteria
You may qualify if:
- 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)
- th 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Duke University Medical Center
Durham, North Carolina, 27708, United States
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Demark-Wahnefried W, Jones LW, Snyder DC, Sloane RJ, Kimmick GG, Hughes DC, Badr HJ, Miller PE, Burke LE, Lipkus IM. Daughters and Mothers Against Breast Cancer (DAMES): main outcomes of a randomized controlled trial of weight loss in overweight mothers with breast cancer and their overweight daughters. Cancer. 2014 Aug 15;120(16):2522-34. doi: 10.1002/cncr.28761. Epub 2014 May 7.
PMID: 24804802RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy Demark-Wahnefried, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2008
First Posted
March 7, 2008
Study Start
February 1, 2008
Primary Completion
March 1, 2010
Study Completion
July 1, 2010
Last Updated
February 2, 2017
Record last verified: 2012-07