Clinical trial NCT04321135: Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors
Official title: Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Gynecologic Cancer
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Loyola University Chicago
First posted: 2020-03-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either a guided or self-guided lifestyle intervention
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Self-identify as Hispanic or Latina
2. Female
3. Stage 0 -III Breast and Gynecological cancer survivors
4. Treatment (surgery, chemotherapy and/or radiation) completed at least three months before recruitment (ongoing hormonal therapy is acceptable)
5. Age \>18 at time of diagnosis
6. 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:

1. Plans to move from the community during the study
2. A medical condition limiting adherence to diet or physical activity components
3. History of significant mental illness
4. Currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study
5. 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

Primary outcomes:
measure: Change in body composition
timeFrame: Baseline to 4 month
measure: Change in intake of fruits and vegetables
timeFrame: Baseline to 4 month
measure: Change of intake of red meat/processed meat
timeFrame: Baseline to 4 month
measure: Change in levels of physical activity- minutes per week
timeFrame: Baseline to 4 month
measure: Change in levels of physical activity- #times per week
timeFrame: Baseline to 4 month
measure: Change in resistance training- Handgrip strength
timeFrame: Baseline to 4 month
measure: Change in resistance training- Strength and endurance
timeFrame: Baseline to 4 month
measure: Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System)
timeFrame: Baseline to 4 month
measure: Changes in Systolic and Diastolic Blood Pressure
timeFrame: Baseline to 4 month
measure: Change in Biomarkers- Lipids
timeFrame: Baseline to 4 month
measure: Change in Biomarkers- Glycohem
timeFrame: Baseline to 4 month
measure: Change in Biomarkers- Glucose
timeFrame: Baseline to 4 month
measure: Change in Biomarkers- C-Peptide
timeFrame: Baseline to 4 month
measure: Change in Biomarkers- Insulin
timeFrame: Baseline to 4 month
measure: Change in Biomarkers- hs CRP
timeFrame: Baseline to 4 month
measure: Change in Biomarkers-Adipokines- Adiponectin
timeFrame: Baseline to 4 month
measure: Change in Biomarkers-Adipokines- Leptin
timeFrame: Baseline to 4 month
measure: Change in waist circumference
timeFrame: Baseline to 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: