Breast Cancer, Gynecologic Cancer
Conditions
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.
Interventions
BEHAVIORALGuided Lifestyle Program Intervention
The Guided Lifestyle Program will receive sessions that meet twice weekly and 2-3 text messages weekly.They will also receive a participant informational binder (wellness guide) with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.
BEHAVIORALSelf-Guided Lifestyle Program (Control Arm)
In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging
Sponsors
Loyola University Chicago
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomized to either a guided or self-guided lifestyle intervention
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body composition | Baseline to 4 month | Ratio of percent lean mass to percent adiposity as measured by Bio-electrical Impedance Analysis Scale. More lean mass and less adiposity is favorable |
| Change in intake of fruits and vegetables | Baseline to 4 month | ASA24 dietary analysis of self reported food consumption |
| Change of intake of red meat/processed meat | Baseline to 4 month | ASA24 dietary analysis of self reported food consumption |
| Change in levels of physical activity- minutes per week | Baseline to 4 month | Change of ActiGraph monitored activity |
| Change in levels of physical activity- #times per week | Baseline to 4 month | Change of ActiGraph monitored activity |
| Change in resistance training- Handgrip strength | Baseline to 4 month | Jamar Plus Digital Hand Dynamometer |
| Change in resistance training- Strength and endurance | Baseline to 4 month | 30-Second Chair Stand (Sit to Stand) |
| Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System) | Baseline to 4 month | Patient Reported Outcomes Measurement Information System (PROMIS) T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average. |
| Changes in Systolic and Diastolic Blood Pressure | Baseline to 4 month | Participants systolic and diastolic blood pressure will be measured using a digital, automated unit |
| Change in Biomarkers- Lipids | Baseline to 4 month | Lipid blood tests measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers- Glycohem | Baseline to 4 month | Glycohem blood tests measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers- Glucose | Baseline to 4 month | Glucose blood tests measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers- C-Peptide | Baseline to 4 month | C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers- Insulin | Baseline to 4 month | Insulin blood tests measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers- hs CRP | Baseline to 4 month | hs CRP blood tests measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers-Adipokines- Adiponectin | Baseline to 4 month | Adiponectin blood tests |
| Change in Biomarkers-Adipokines- Leptin | Baseline to 4 month | Adiponectin blood tests |
| Change in waist circumference | Baseline to 4 month | Change in waist circumference measurement |
Countries
United States
Outcome results
None listed