Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors

Study Overview
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Brief Summary
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This clinical trial evaluates a remotely delivered, culturally tailored weight loss interventions in Latina breast cancer (BC) survivors. Cancer is the leading cause of death among Latinos, and among Latinas, BC is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight/obesity, which is associated with poorer BC outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina BC survivors. The development of an adaptive program that provides survivors the support they need, as opposed to what is typically available, is essential to reducing persistent inequities in cancer survivorship.

Detailed Description
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OUTLINE: This study includes a baseline run-in and randomized stage I and stage II studies. BASELINE: Participants receive written instructions and website link to an instructional video along with supportive materials including measuring tape, Aria wireless fidelity (WiFi)-enabled scale, and Actigraph accelerometer to be worn for 7 days at baseline. Patients also undergo blood sample collection at baseline. STAGE I: Eligible participants from the baseline run-in are randomized to arm I or II. ARM I: Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Patients also undergo blood sample collection on study. ARM II: Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions on study. Patients also undergo blood sample collection on study. STAGE II: Participants who achieve >= 2% weight loss (responders) at week 4 will continue their assigned interventions in stage I. Participants who achieve < 2% weight loss (non-responders) at week 4 will be re-randomized to 1 of 4 arms. Participants who were assigned to arm I in stage I are randomized to arm III or IV. Participants who were assigned to arm II in stage I are randomized to arms V or VI. ARM III: Participants receive interventions as in arm II. ARM IV: Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 14 30-minute individualized telephone health coaching sessions. Patients also undergo blood sample collection on study. ARM V: Participants receive interventions as in arm IV. ARM VI: Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 14 30-minute individualized telephone health coaching sessions and receive a bag of groceries each month on study. Patients also undergo blood sample collection on study.

Official Title
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Using a SMART Design to Evaluate Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors

Conditions
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Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8

Intervention / Treatment
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* Behavioral: Behavioral Dietary Intervention
* Behavioral: Behavioral Intervention
* Procedure: Biospecimen Collection
* Other: Dietary Intervention
* Other: Educational Intervention
* Other: Exercise Intervention
* Other: Health Promotion and Education
* Other: Internet-Based Intervention
* Other: Interview
* Behavioral: Lifestyle Counseling
* Other: Medical Device Usage and Evaluation
* Other: Medical Device Usage and Evaluation
* Other: Nutritional Intervention
* Other: Questionnaire Administration
* Behavioral: Telephone-Based Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biologically female Age >= 18 years Self-identifies Hispanic/Latina Fluent in Spanish and/or English Previously diagnosis of stage I-III BC within the past 5 years No evidence of recurrent or metastatic disease > 60 days post treatment (current endocrine therapy allowed) Body mass index (BMI) >= 30 kg/m^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and WiFi-enabled scale Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Physician written clearance for participation in a 12 month weight loss program Willingness to participate in all study activities Access to phone for study contacts Access to internet and smartphone, tablet, or computer to participate in the online program and to be able to sync study WiFi devices Lives within grocery delivery range for online delivery service Successful completion of at-home baseline assessments prior to randomization Exclusion Criteria: Body mass index (BMI) < 30 kg/m^2 Active smoker Diabetic with use of insulin or other hypoglycemic medication Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA Pregnant, breastfeeding, or planning to become pregnant during the study period Use of exogenous hormones for gender affirmation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baseline (instructions, video, tape, scale, accelerometer)<br>Participants receive written instructions and website link to an instructional video along with supportive materials including measuring tape, Aria WiFi-enabled scale, and Actigraph accelerometer to be worn for 7 days at baseline. Patients also undergo blood sample collection at baseline. | Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Specimen Collection;Other: Health Promotion and Education<br>* Receive written instructions and website link to instructional video<br>Other: Medical Device Usage and Evaluation<br>* Use measuring tape, Aria Wifi-enable scale, and Actigraph accelerometer<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Stage I, Arm I (¡Vida!)<br>Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Patients also undergo blood sample collection on study. | Behavioral: Behavioral Intervention<br>* Participate in ¡Vida! program<br>* Other names: Behavioral Treatments;Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Specimen Collection;Other: Dietary Intervention<br>* Receive dietary modifications<br>* Other names: Nutritional Interventions;Other: Educational Intervention<br>* Attend online health education sessions<br>* Other names: Intervention, Educational;Other: Exercise Intervention<br>* Perform home-based exercise sessions<br>Other: Internet-Based Intervention<br>* Use Fitbit app<br>Other: Interview<br>* Ancillary studies<br>Other: Medical Device Usage and Evaluation<br>* Use Fitbit scale and Fitbit Luxe (or latest model)<br>Other: Nutritional Intervention<br>* Use Cook for Your Life website<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Stage I, Arm II (¡Vida!, lifestyle sessions)<br>Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions on study. Patients also undergo blood sample collection on study. | Behavioral: Behavioral Intervention<br>* Participate in ¡Vida! program<br>* Other names: Behavioral Treatments;Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Specimen Collection;Other: Dietary Intervention<br>* Receive dietary modifications<br>* Other names: Nutritional Interventions;Other: Educational Intervention<br>* Attend online health education sessions<br>* Other names: Intervention, Educational;Other: Exercise Intervention<br>* Perform home-based exercise sessions<br>Other: Internet-Based Intervention<br>* Use Fitbit app<br>Other: Interview<br>* Ancillary studies<br>Behavioral: Lifestyle Counseling<br>* Attend remote lifestyle health education sessions<br>Other: Medical Device Usage and Evaluation<br>* Use Fitbit scale and Fitbit Luxe (or latest model)<br>Other: Nutritional Intervention<br>* Use Cook for Your Life website<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Stage II, Arm III (¡Vida!, lifestyle sessions)<br>Participants receive interventions as in arm II. | Behavioral: Behavioral Intervention<br>* Participate in ¡Vida! program<br>* Other names: Behavioral Treatments;Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Specimen Collection;Other: Dietary Intervention<br>* Receive dietary modifications<br>* Other names: Nutritional Interventions;Other: Educational Intervention<br>* Attend online health education sessions<br>* Other names: Intervention, Educational;Other: Exercise Intervention<br>* Perform home-based exercise sessions<br>Other: Internet-Based Intervention<br>* Use Fitbit app<br>Other: Interview<br>* Ancillary studies<br>Behavioral: Lifestyle Counseling<br>* Attend remote lifestyle health education sessions<br>Other: Medical Device Usage and Evaluation<br>* Use Fitbit scale and Fitbit Luxe (or latest model)<br>Other: Nutritional Intervention<br>* Use Cook for Your Life website<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)<br>Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 14 30-minute individualized telephone health coaching sessions. Patients also undergo blood sample collection on study. | Behavioral: Behavioral Intervention<br>* Participate in ¡Vida! program<br>* Other names: Behavioral Treatments;Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Specimen Collection;Other: Dietary Intervention<br>* Receive dietary modifications<br>* Other names: Nutritional Interventions;Other: Educational Intervention<br>* Attend online health education sessions<br>* Other names: Intervention, Educational;Other: Exercise Intervention<br>* Perform home-based exercise sessions<br>Other: Internet-Based Intervention<br>* Use Fitbit app<br>Other: Interview<br>* Ancillary studies<br>Behavioral: Lifestyle Counseling<br>* Attend remote lifestyle health education sessions<br>Other: Medical Device Usage and Evaluation<br>* Use Fitbit scale and Fitbit Luxe (or latest model)<br>Other: Nutritional Intervention<br>* Use Cook for Your Life website<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Participate in individualized health coaching sessions<br>|
| Experimental: Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)<br>Participants receive interventions as in arm IV. | Behavioral: Behavioral Intervention<br>* Participate in ¡Vida! program<br>* Other names: Behavioral Treatments;Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Specimen Collection;Other: Dietary Intervention<br>* Receive dietary modifications<br>* Other names: Nutritional Interventions;Other: Educational Intervention<br>* Attend online health education sessions<br>* Other names: Intervention, Educational;Other: Exercise Intervention<br>* Perform home-based exercise sessions<br>Other: Internet-Based Intervention<br>* Use Fitbit app<br>Other: Interview<br>* Ancillary studies<br>Behavioral: Lifestyle Counseling<br>* Attend remote lifestyle health education sessions<br>Other: Medical Device Usage and Evaluation<br>* Use Fitbit scale and Fitbit Luxe (or latest model)<br>Other: Nutritional Intervention<br>* Use Cook for Your Life website<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Participate in individualized health coaching sessions<br>|
| Experimental: Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))<br>Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 14 30-minute individualized telephone health coaching sessions and receive a bag of groceries each month on study. Patients also undergo blood sample collection on study. | Behavioral: Behavioral Dietary Intervention<br>* Receive delivered groceries<br>Behavioral: Behavioral Intervention<br>* Participate in ¡Vida! program<br>* Other names: Behavioral Treatments;Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Specimen Collection;Other: Dietary Intervention<br>* Receive dietary modifications<br>* Other names: Nutritional Interventions;Other: Educational Intervention<br>* Attend online health education sessions<br>* Other names: Intervention, Educational;Other: Exercise Intervention<br>* Perform home-based exercise sessions<br>Other: Internet-Based Intervention<br>* Use Fitbit app<br>Other: Interview<br>* Ancillary studies<br>Behavioral: Lifestyle Counseling<br>* Attend remote lifestyle health education sessions<br>Other: Medical Device Usage and Evaluation<br>* Use Fitbit scale and Fitbit Luxe (or latest model)<br>Other: Nutritional Intervention<br>* Use Cook for Your Life website<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Participate in individualized health coaching sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight (kg) percent change | Will be assessed by the percent of weight loss at month 12 and compared across the four embedded adaptive intervention (EAI) groups using the doubly robust estimator model. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight (kg) percent change as moderated by baseline characteristics | Will be determined by whether EAI effectiveness is moderated by baseline patient characteristics. | Up to 12 months |