DAMES: Daughters And MothErS Against Breast Cancer
|ClinicalTrials.gov Identifier: NCT00630591|
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : February 2, 2017
-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:
- Accrual of 67 mother-daughter dyads into the intervention is accomplished within a 1-year period;
- An attrition rate of less than 20% is achieved; and
- 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.
-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).
-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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Standardized Materials Group Behavioral: Independent Tailored Intervention Behavioral: Partner-Assisted Tailored Intervention||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||482 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||DAMES: Daughters And MothErS Against Breast Cancer|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||July 2010|
|Experimental: Standardized Materials Group||
Behavioral: Standardized Materials Group
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.
|Experimental: Independent Tailored Intervention||
Behavioral: Independent Tailored Intervention
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.
|Experimental: Partner-Assisted Tailored Intervention||
Behavioral: Partner-Assisted Tailored Intervention
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.
- Overall Accrual [ Time Frame: 12-Months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630591
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27708|
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Wendy Demark-Wahnefried, PhD||M.D. Anderson Cancer Center|