Breast Cancer Clinical Trial

Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors

Summary

This study examine the feasibility and efficacy of Avanzando Juntas, a four-month community-based lifestyle intervention rooted in the evidence-based Moving Forward lifestyle intervention developed with and for AA breast cancer survivors. This intervention was adapted in collaboration with Hispanic/Latina BC & GC survivors. It will offer twice-weekly sessions aimed at supporting adherence to ACS nutrition and physical activity guidelines to promote weight loss and improved quality of life.

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Full Description

Aim 1. To adapt the Moving Forward weight loss intervention for overweight/obese Hispanic BCS using an iterative process engaging Hispanic BCS and a community advisory committee.

Aim 2. To conduct a randomized pilot with 40 overweight/obese Hispanic BCS to establish the feasibility of the adapted Moving Forward program based on recruitment, adherence, retention and efficacy.

Aim 3. To explore the effects of the adapted Moving Forward program (Avanzando Juntas) on anthropometric (weight, % body fat, lean mass), behavioral (dietary intake, physical activity) psychosocial (quality of life) and biological (cholesterol, hemoglobin A1c, adiponectin, leptin, inflammation, insulin resistance) outcomes.

Hypothesis: Women in the weight loss program will exhibit improvements in outcomes compared to women in the wait list control group.

Avanzando Juntas supports BC & GC survivors in adopting physical activity and eating patterns to promote weight loss, bolster QOL and reduce the risk for comorbidities and, potentially, BC & GC recurrence. A strong, multidisciplinary study team provides expertise in culturally competent programs for Hispanic BCS, cognitive behavioral lifestyle interventions, body composition, breast cancer and program adaptation.

This study is novel in its focus on weight loss among Hispanic BCS and the incorporation of anthropometric, behavioral, biological and psychosocial outcomes. An additional strength is the foundation of community partnerships that will support the current study's efforts, as well as those for a larger trial, and, if successful, the dissemination of the program.

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Eligibility Criteria

Inclusion Criteria:

Self-identify as Hispanic or Latina
Female
Stage 0 -III Breast and Gynecological cancer survivors
Treatment (surgery, chemotherapy and/or radiation) completed at least three months before recruitment (ongoing hormonal therapy is acceptable)
Age >18 at time of diagnosis
BMI at least 25 kg/m2 BMI between 25 and 55 - chosen because this will include only those participants who are overweight and would not be harmed by a 5% weight loss

Exclusion Criteria:

Plans to move from the community during the study
A medical condition limiting adherence to diet or physical activity components
History of significant mental illness
Currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study
Taking any medications prescribed by a doctor to lose weight participate in any organized weight loss programs or has undergone weight loss surgery or planning to undergo weight loss surgery in the next year

Study is for people with:

Breast Cancer

Estimated Enrollment:

40

Study ID:

NCT04321135

Recruitment Status:

Active, not recruiting

Sponsor:

Medical College of Wisconsin

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There is 1 Location for this study

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Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

40

Study ID:

NCT04321135

Recruitment Status:

Active, not recruiting

Sponsor:


Medical College of Wisconsin

How clear is this clinincal trial information?

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