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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Biospecimen Collection; Other: Interview; Other: Health Promotion and Education; Other: Medical Device Usage and Evaluation; Other: Medical Device Usage and Evaluation; Behavioral: Behavioral Intervention; Other: Dietary Intervention; Other: Educational Intervention; Other: Exercise Intervention; Other: Internet-Based Intervention; Other: Nutritional Intervention; Behavioral: Lifestyle Counseling; Behavioral: Telephone-Based Intervention; Behavioral: Behavioral Dietary Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 620
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Greenlee; Phone Number: 206-667-4502; Email: hgreenlee@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Heather Greenlee; Phone Number: 206-667-4502; Email: hgreenlee@fredhutch.org
      • Principal Investigator: Heather Greenlee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baseline (instructions, video, tape, scale, accelerometer); 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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Health Promotion and Education; Receive written instructions and website link to instructional video; Other: Medical Device Usage and Evaluation; Use measuring tape, Aria Wifi-enable scale, and Actigraph accelerometer; Other: Medical Device Usage and Evaluation; Use Fitbit scale and Fitbit Luxe (or latest model)
Experimental: Stage I, Arm I (¡Vida!); 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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Interview; Ancillary studies; Other: Medical Device Usage and Evaluation; Use measuring tape, Aria Wifi-enable scale, and Actigraph accelerometer; Other: Medical Device Usage and Evaluation; Use Fitbit scale and Fitbit Luxe (or latest model); Behavioral: Behavioral Intervention; Participate in ¡Vida! program; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Other: Dietary Intervention; Receive dietary modifications; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Educational Intervention; Attend online health education sessions; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Exercise Intervention; Perform home-based exercise sessions; Other: Internet-Based Intervention; Use Fitbit app; Other: Nutritional Intervention; Use Cook for Your Life website
Experimental: Stage I, Arm II (¡Vida!, lifestyle sessions); 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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Interview; Ancillary studies; Other: Medical Device Usage and Evaluation; Use measuring tape, Aria Wifi-enable scale, and Actigraph accelerometer; Other: Medical Device Usage and Evaluation; Use Fitbit scale and Fitbit Luxe (or latest model); Behavioral: Behavioral Intervention; Participate in ¡Vida! program; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Other: Dietary Intervention; Receive dietary modifications; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Educational Intervention; Attend online health education sessions; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Exercise Intervention; Perform home-based exercise sessions; Other: Internet-Based Intervention; Use Fitbit app; Other: Nutritional Intervention; Use Cook for Your Life website; Behavioral: Lifestyle Counseling; Attend remote lifestyle health education sessions
Experimental: Stage II, Arm III (¡Vida!, lifestyle sessions); Participants receive interventions as in arm II.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Interview; Ancillary studies; Other: Medical Device Usage and Evaluation; Use measuring tape, Aria Wifi-enable scale, and Actigraph accelerometer; Other: Medical Device Usage and Evaluation; Use Fitbit scale and Fitbit Luxe (or latest model); Behavioral: Behavioral Intervention; Participate in ¡Vida! program; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Other: Dietary Intervention; Receive dietary modifications; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Educational Intervention; Attend online health education sessions; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Exercise Intervention; Perform home-based exercise sessions; Other: Internet-Based Intervention; Use Fitbit app; Other: Nutritional Intervention; Use Cook for Your Life website; Behavioral: Lifestyle Counseling; Attend remote lifestyle health education sessions
Experimental: Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching); 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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Interview; Ancillary studies; Other: Medical Device Usage and Evaluation; Use measuring tape, Aria Wifi-enable scale, and Actigraph accelerometer; Other: Medical Device Usage and Evaluation; Use Fitbit scale and Fitbit Luxe (or latest model); Behavioral: Behavioral Intervention; Participate in ¡Vida! program; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Other: Dietary Intervention; Receive dietary modifications; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Educational Intervention; Attend online health education sessions; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Exercise Intervention; Perform home-based exercise sessions; Other: Internet-Based Intervention; Use Fitbit app; Other: Nutritional Intervention; Use Cook for Your Life website; Behavioral: Lifestyle Counseling; Attend remote lifestyle health education sessions; Behavioral: Telephone-Based Intervention; Participate in individualized health coaching sessions
Experimental: Stage II, Arm V (¡Vida!, lifestyle sessions, coaching); Participants receive interventions as in arm IV.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Interview; Ancillary studies; Other: Medical Device Usage and Evaluation; Use measuring tape, Aria Wifi-enable scale, and Actigraph accelerometer; Other: Medical Device Usage and Evaluation; Use Fitbit scale and Fitbit Luxe (or latest model); Behavioral: Behavioral Intervention; Participate in ¡Vida! program; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Other: Dietary Intervention; Receive dietary modifications; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Educational Intervention; Attend online health education sessions; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Exercise Intervention; Perform home-based exercise sessions; Other: Internet-Based Intervention; Use Fitbit app; Other: Nutritional Intervention; Use Cook for Your Life website; Behavioral: Lifestyle Counseling; Attend remote lifestyle health education sessions; Behavioral: Telephone-Based Intervention; Participate in individualized health coaching sessions
Experimental: Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food)); 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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Interview; Ancillary studies; Other: Medical Device Usage and Evaluation; Use measuring tape, Aria Wifi-enable scale, and Actigraph accelerometer; Other: Medical Device Usage and Evaluation; Use Fitbit scale and Fitbit Luxe (or latest model); Behavioral: Behavioral Intervention; Participate in ¡Vida! program; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Other: Dietary Intervention; Receive dietary modifications; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Educational Intervention; Attend online health education sessions; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Exercise Intervention; Perform home-based exercise sessions; Other: Internet-Based Intervention; Use Fitbit app; Other: Nutritional Intervention; Use Cook for Your Life website; Behavioral: Lifestyle Counseling; Attend remote lifestyle health education sessions; Behavioral: Telephone-Based Intervention; Participate in individualized health coaching sessions; Behavioral: Behavioral Dietary Intervention; Receive delivered groceries

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Heather Greenlee, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Body Weight; Body Weight Changes; Breast Neoplasms; Weight Loss
• Other Study ID Numbers: RG1123416 (Fred Hutch/University of Washington Cancer Consortium); NCI-2023-03748 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA270441 (U.S. NIH Grant/Contract); 0020054 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No