Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
About this trial
This is an interventional prevention trial for Anatomic Stage I Breast Cancer AJCC v8
Eligibility Criteria
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
Sites / Locations
- Fred Hutch/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Baseline (instructions, video, tape, scale, accelerometer)
Stage I, Arm I (¡Vida!)
Stage I, Arm II (¡Vida!, lifestyle sessions)
Stage II, Arm III (¡Vida!, lifestyle sessions)
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
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.
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.
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.
Participants receive interventions as in 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 and receive 14 30-minute individualized telephone health coaching sessions. Patients also undergo blood sample collection on study.
Participants receive interventions as in 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 and receive a bag of groceries each month on study. Patients also undergo blood sample collection on study.