Trial Title:
Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors
NCT ID:
NCT05930483
Condition:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Conditions: Official terms:
Breast Neoplasms
Weight Loss
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Behavioral Dietary Intervention
Description:
Receive delivered groceries
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Intervention type:
Behavioral
Intervention name:
Behavioral Intervention
Description:
Participate in ¡Vida! program
Arm group label:
Stage I, Arm I (¡Vida!)
Arm group label:
Stage I, Arm II (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm III (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Other name:
Behavior Conditioning Therapy
Other name:
Behavior Modification
Other name:
Behavior or Life Style Modifications
Other name:
Behavior Therapy
Other name:
Behavioral Interventions
Other name:
Behavioral Modification
Other name:
Behavioral Therapy
Other name:
Behavioral Treatment
Other name:
Behavioral Treatments
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Baseline (instructions, video, tape, scale, accelerometer)
Arm group label:
Stage I, Arm I (¡Vida!)
Arm group label:
Stage I, Arm II (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm III (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Receive dietary modifications
Arm group label:
Stage I, Arm I (¡Vida!)
Arm group label:
Stage I, Arm II (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm III (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Other
Intervention name:
Educational Intervention
Description:
Attend online health education sessions
Arm group label:
Stage I, Arm I (¡Vida!)
Arm group label:
Stage I, Arm II (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm III (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Other name:
Education for Intervention
Other name:
Intervention by Education
Other name:
Intervention through Education
Other name:
Intervention, Educational
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Perform home-based exercise sessions
Arm group label:
Stage I, Arm I (¡Vida!)
Arm group label:
Stage I, Arm II (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm III (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Intervention type:
Other
Intervention name:
Health Promotion and Education
Description:
Receive written instructions and website link to instructional video
Arm group label:
Baseline (instructions, video, tape, scale, accelerometer)
Intervention type:
Other
Intervention name:
Internet-Based Intervention
Description:
Use Fitbit app
Arm group label:
Stage I, Arm I (¡Vida!)
Arm group label:
Stage I, Arm II (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm III (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Stage I, Arm I (¡Vida!)
Arm group label:
Stage I, Arm II (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm III (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Intervention type:
Behavioral
Intervention name:
Lifestyle Counseling
Description:
Attend remote lifestyle health education sessions
Arm group label:
Stage I, Arm II (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm III (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Use measuring tape, Aria Wifi-enable scale, and Actigraph accelerometer
Arm group label:
Baseline (instructions, video, tape, scale, accelerometer)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Use Fitbit scale and Fitbit Luxe (or latest model)
Arm group label:
Stage I, Arm I (¡Vida!)
Arm group label:
Stage I, Arm II (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm III (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Intervention type:
Other
Intervention name:
Nutritional Intervention
Description:
Use Cook for Your Life website
Arm group label:
Stage I, Arm I (¡Vida!)
Arm group label:
Stage I, Arm II (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm III (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Baseline (instructions, video, tape, scale, accelerometer)
Arm group label:
Stage I, Arm I (¡Vida!)
Arm group label:
Stage I, Arm II (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm III (¡Vida!, lifestyle sessions)
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Intervention type:
Behavioral
Intervention name:
Telephone-Based Intervention
Description:
Participate in individualized health coaching sessions
Arm group label:
Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)
Arm group label:
Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))
Summary:
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:
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Contact:
Last name:
Heather Greenlee
Phone:
206-667-4502
Email:
hgreenlee@fredhutch.org
Investigator:
Last name:
Heather Greenlee
Email:
Principal Investigator
Start date:
December 1, 2024
Completion date:
March 1, 2028
Lead sponsor:
Agency:
Fred Hutchinson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Fred Hutchinson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05930483
