DAMES: Daughters And MothErS Against Breast Cancer

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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 that emphasizes the mother-daughter bond and one that is delivered to each independently) vs. standardized materials (attention control). This aim will be accomplished by assessing overall accrual, and by quantifying retention and adverse events in each study arm. The study will be deemed feasible if it achieves the following criteria: 1. Accrual of 67 mother-daughter dyads into the intervention is accomplished within a 1-year period; 2. An attrition rate of less than 20% is achieved; and 3. The frequency of total adverse events is not significantly higher in either of the intervention arms (as compared to the attention control arm), and there is no more than one reported serious adverse event that is directly attributable to either of the interventions. Detailed process data also will be collected on each intervention, i.e., use and perceived helpfulness of materials in promoting behavior change, frequency and quality of interaction between members of the mother-daughter dyad, feedback regarding intervention materials, etc. Secondary 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.

Key facts

Study ID

NCT00630591

Run by

Duke University

People needed

482

Starts

2008-02-01

Expected to finish

2010-07-01

Last updated by the study team

2017-02-02

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

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)
• 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)

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).

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• U.T. M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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