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

NCT04321135 | Completed DMC

• 1 other identifier: PRO00030295
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Gynecologic Cancer

Outcome Measures

Primary Outcomes (18)

• Change in body composition

  Ratio of percent lean mass to percent adiposity as measured by Bio-electrical Impedance Analysis Scale. More lean mass and less adiposity is favorable

  Baseline to 4 month

• Change in intake of fruits and vegetables

  ASA24 dietary analysis of self reported food consumption

  Baseline to 4 month

• Change of intake of red meat/processed meat

  ASA24 dietary analysis of self reported food consumption

  Baseline to 4 month

• Change in levels of physical activity- minutes per week

  Change of ActiGraph monitored activity

  Baseline to 4 month

• Change in levels of physical activity- #times per week

  Change of ActiGraph monitored activity

  Baseline to 4 month

• Change in resistance training- Handgrip strength

  Jamar Plus Digital Hand Dynamometer

  Baseline to 4 month

• Change in resistance training- Strength and endurance

  30-Second Chair Stand (Sit to Stand)

  Baseline to 4 month

• Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System)

  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.

  Baseline to 4 month

• Changes in Systolic and Diastolic Blood Pressure

  Participants systolic and diastolic blood pressure will be measured using a digital, automated unit

  Baseline to 4 month

• Change in Biomarkers- Lipids

  Lipid blood tests measured by Wisconsin Diagnostic Laboratory

  Baseline to 4 month

• Change in Biomarkers- Glycohem

  Glycohem blood tests measured by Wisconsin Diagnostic Laboratory

  Baseline to 4 month

• Change in Biomarkers- Glucose

  Glucose blood tests measured by Wisconsin Diagnostic Laboratory

  Baseline to 4 month

• Change in Biomarkers- C-Peptide

  C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory

  Baseline to 4 month

• Change in Biomarkers- Insulin

  Insulin blood tests measured by Wisconsin Diagnostic Laboratory

  Baseline to 4 month

• Change in Biomarkers- hs CRP

  hs CRP blood tests measured by Wisconsin Diagnostic Laboratory

  Baseline to 4 month

• Change in Biomarkers-Adipokines- Adiponectin

  Adiponectin blood tests

  Baseline to 4 month

• Change in Biomarkers-Adipokines- Leptin

  Adiponectin blood tests

  Baseline to 4 month

• Change in waist circumference

  Change in waist circumference measurement

  Baseline to 4 month

Study Arms (2)

Guided Lifestyle Program

EXPERIMENTAL

The Intervention will be conducted in a cohort of 20 (anticipated) and is designed to increase self-efficacy, social support and perceived access to healthy eating and exercise resources and promote weight loss. Participants assigned to the Guided Lifestyle Program will participate in twice weekly sessions - the first weekly session will be 120 minutes in length with the first hour addressing lifestyle change education and strategies. The second hour will be supervised exercise including aerobics and resistance training. The second weekly session will be a one-hour supervised exercise session. Participants will also receive 2-3 text messages weekly.They will also receive a participant informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.The Guided Lifestyle program is four months long (16 weeks). Please note, the Guided Lifestyle program participants will be offered a booster session off-study.

Behavioral: Guided Lifestyle Program Intervention

Self-Guided Lifestyle Program

ACTIVE COMPARATOR

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. The study team will call these participants once a month to check in.

Behavioral: Self-Guided Lifestyle Program (Control Arm)

Interventions

Guided Lifestyle Program Intervention BEHAVIORAL

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.

Guided Lifestyle Program

Self-Guided Lifestyle Program (Control Arm) BEHAVIORAL

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

Self-Guided Lifestyle Program

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female Breast and Gynecological study participants
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Loyola University Chicago: collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director for Cancer Prevention and Control

Model Details: Participants will be randomized to either a guided or self-guided lifestyle intervention

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 25, 2020
• Study Start: November 1, 2019
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

US (1)