ACTIVE_NOT_RECRUITING

Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity

Conditions

Breast Cancer Coronary Artery Disease Stroke Type2 Diabetes Exercise Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors.

Official Title

Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial

Quick Facts

Study Start:2021-08-12

Study Completion:2026-06-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04717050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Women newly diagnosed (Stage I-III) breast cancer. * Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease * The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately. * Are centrally obese with the following criteria\[84\] (determined by study team at eligibility screening): BMI \>30 kg/m2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat \>30% (estimated by bioelectrical impedance), and waist circumference \>35 in. * Have undergone a lumpectomy or mastectomy. * Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months. * Speak English or Spanish * Self-identify as Latina * Is in breast cancer remission with no detectable disease present * Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity) * Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease * Have not experienced a weight reduction ≥10% within the past 6 months * Currently participate in less than 60 minutes of structured exercise/week * No planned reconstructive surgery with flap repair during trial and follow-up period * May use adjuvant endocrine therapy if use will be continued for duration of study intervention * Does not smoke (no smoking during previous 12 months) * Willing to travel to Dana-Farber Cancer Institute for necessary data collection * Ability to understand and the willingness to sign a written informed consent document.	* Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease; women using Metformin to manage diabetes will be excluded from the trial * Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy * Patients with other active malignancies are ineligible for this study. * Patients with metastatic disease * Is not centrally obese as defined above * Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis * History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise * Participates in more than 60 minutes of structured exercise/week * Is planning reconstructive surgery with flap repair during trial and follow-up period * Currently smokes * Is unable to travel to Dana-Farber Cancer Institute and/or exercise facility for necessary data collection * Weight reduction ≥ 10% within past 6 months * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Inclusion Criteria

Exclusion Criteria

* Women newly diagnosed (Stage I-III) breast cancer.
* Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
* The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
* Are centrally obese with the following criteria\[84\] (determined by study team at eligibility screening): BMI \>30 kg/m2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat \>30% (estimated by bioelectrical impedance), and waist circumference \>35 in.
* Have undergone a lumpectomy or mastectomy.
* Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months.
* Speak English or Spanish
* Self-identify as Latina
* Is in breast cancer remission with no detectable disease present
* Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
* Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease
* Have not experienced a weight reduction ≥10% within the past 6 months
* Currently participate in less than 60 minutes of structured exercise/week
* No planned reconstructive surgery with flap repair during trial and follow-up period
* May use adjuvant endocrine therapy if use will be continued for duration of study intervention
* Does not smoke (no smoking during previous 12 months)
* Willing to travel to Dana-Farber Cancer Institute for necessary data collection
* Ability to understand and the willingness to sign a written informed consent document.

* Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease; women using Metformin to manage diabetes will be excluded from the trial
* Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
* Patients with other active malignancies are ineligible for this study.
* Patients with metastatic disease
* Is not centrally obese as defined above
* Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
* History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
* Participates in more than 60 minutes of structured exercise/week
* Is planning reconstructive surgery with flap repair during trial and follow-up period
* Currently smokes
* Is unable to travel to Dana-Farber Cancer Institute and/or exercise facility for necessary data collection
* Weight reduction ≥ 10% within past 6 months
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Contacts and Locations

Principal Investigator

Christina Dieli-Conwright, PhD, MPH

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Christina Dieli-Conwright, PhD, MPH, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-12

Study Completion Date2026-06-15

Study Record Updates

Study Start Date2021-08-12

Study Completion Date2026-06-15

Terms related to this study

Keywords Provided by Researchers

Breast Cancer
Coronary Artery Disease
Stroke
Type2 Diabetes
Exercise Therapy

Additional Relevant MeSH Terms

Breast Cancer
Coronary Artery Disease
Stroke
Type2 Diabetes