DAMES: Daughters And MothErS Against Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00630591
First received: February 28, 2008
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Standardized Materials Group
Behavioral: Independent Tailored Intervention
Behavioral: Partner-Assisted Tailored Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: DAMES: Daughters And MothErS Against Breast Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Accrual [ Time Frame: 12-Months ] [ Designated as safety issue: No ]

Enrollment: 482
Study Start Date: February 2008
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. DCIS or Stage I-IIIA Breast Cancer (MOTHERS)
  2. Have a biological daughter at least 21 years old (MOTHERS)
  3. Body Mass Index between 25 - 40 (MOTHERS) or 25 or above (DAUGHTERS)
  4. English Speaking & Writing (MOTHERS & DAUGHTERS)
  5. 5th grade or higher educational level (MOTHERS & DAUGHTERS)
  6. Willingness to be randomized into the standardized or tailored intervention arms and to undergo baseline and follow-up assessments (MOTHERS & DAUGHTERS)
  7. Must be at least 21 years of age (MOTHERS & DAUGHTERS)
  8. 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 Criteria:

  1. Evidence of progressive breast cancer or 2nd primaries (MOTHERS)
  2. 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)
  3. Currently exercising 30+ minutes/day for 5+ days/week (<150 minutes per week) (MOTHERS & DAUGHTERS)
  4. Currently enrolled in a weight loss program (MOTHERS & DAUGHTERS)
  5. 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).
  6. Currently pregnant (MOTHERS & DAUGHTERS)
  7. A previous diagnosis of breast cancer (DAUGHTERS).
  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: NCT00630591

Locations
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
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Wendy Demark-Wahnefried, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00630591     History of Changes
Other Study ID Numbers: 2007-0756
Study First Received: February 28, 2008
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Daughters And MothErS Against Breast Cancer
DAMES
Breast Cancer
Weight Loss
Home-based weight loss
Quality of Life
Diet
Exercise
Daughter
Mother
Cancer Prevention
Prevention

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

ClinicalTrials.gov processed this record on October 23, 2014