Breast Cancer - Navigate - Prospective Cohort

Breast Cancer Clinical Trial

Official title:

Effect of a Navigation Intervention on Care Equity for Women of Color Diagnosed With Breast Cancer: A Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06271356
• Other study ID #: STU00220278
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: Betina Yanez
• Phone: 312-503-5341
• Email: betina.yanez[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment. TCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program. Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age and older
• Diagnosed with non-metastatic breast cancer (stages I-III)
• An order placed for a post-operative chemotherapy cycle by a NM clinician
• Not have initiated a recommended post-operative chemotherapy cycle at the time of study enrollment
• Completed surgery for breast cancer
• First-time diagnosis of breast cancer
• Established care at Northwestern Medicine
• English-speaking as the navigation website is not yet available in other languages
• Access to internet on a smart phone or computer/tablet
• Any ethnic background
• We will only consider patients that sign an informed consent form

Exclusion Criteria:

• Men will be excluded because the navigation website only contains content and resources for women. Men also make up less than 1% of all breast cancer diagnoses and the Breast Cancer-Navigate app/website content was developed for female breast cancer patients.
• Diagnosis of additional, life-threatening condition (e.g., end-stage renal disease, heart failure) which can interfere with timely planned adjuvant chemotherapy treatment for cancer.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy
• Quality of Life

Intervention

Behavioral:
• BC-Navigate
BC-Navigate is a website/application to help guide women through care delivery during breast cancer treatment.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	The Chrysalis Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demand of BC-Navi: Recruitment Rate	We assess the demand for the BC-Navi application through study recruitment. Based on previous psychosocial and behavioral studies in oncology, a 75% recruitment rate is considered adequate.	12 weeks
Primary	Demand of BC-Navi: Rentention Rate	Another way we assess demand of the BC-Navi application is through participant retention. Based on previous psychosocial and behavioral studies in oncology, a 75% retention rate is considered adequate .	12 weeks
Primary	Acceptability of BC-Navi	To assess acceptability, all participants are asked to complete an exit interview on BC-Navi. This interview assesses the usefulness, satisfaction, learnability, and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above-average scores on the questionnaire are considered acceptable.	12 weeks
Primary	Preliminary Efficacy: Chemotherapy Initiation	Preliminary efficacy will be measured by time to chemotherapy initiation, which will be operationalized as chemotherapy treatment initiation within 90 days of completion of surgery.	12 weeks