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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05930483
• Other study ID #: RG1123416
• Secondary ID: NCI-2023-0374800
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: June 2023
• Source: Fred Hutchinson Cancer Center
• Contact: Heather Greenlee
• Phone: 206-667-4502
• Email: hgreenlee[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 620
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Neoplasms
• Weight Loss

Intervention

Behavioral:
• Behavioral Dietary Intervention
Receive delivered groceries
• Behavioral Intervention
Participate in ¡Vida! program

Procedure:
• Biospecimen Collection
Undergo blood sample collection

Other:
• Dietary Intervention
Receive dietary modifications
• Educational Intervention
Attend online health education sessions
• Exercise Intervention
Perform home-based exercise sessions
• Health Promotion and Education
Receive written instructions and website link to instructional video
• Internet-Based Intervention
Use Fitbit app
• Interview
Ancillary studies

Behavioral:
• Lifestyle Counseling
Attend remote lifestyle health education sessions

Other:
• Medical Device Usage and Evaluation
Use measuring tape, Aria Wifi-enable scale, and Actigraph accelerometer
• Medical Device Usage and Evaluation
Use Fitbit scale and Fitbit Luxe (or latest model)
• Nutritional Intervention
Use Cook for Your Life website
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Participate in individualized health coaching sessions

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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