Breast Cancer - Navigate - Prospective Cohort

NCT06271356 | Recruiting

• 1 other identifier: STU00220278
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Quality of Life; Chemotherapy

Keywords

eHealth

Outcome Measures

Primary Outcomes (4)

• 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

• Demand of BC-Navi: Retention 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

• 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

• 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

Study Arms (1)

BC-Navi

EXPERIMENTAL

Apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant chemotherapy treatment among diverse breast cancer patients.

Behavioral: BC-Navigate

Interventions

BC-Navigate BEHAVIORAL

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

BC-Navi

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• The Chrysalis Initiative: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Betina Yanez

CONTACT

312-503-5341; betina.yanez@northwestern.edu

Alma Diaz

CONTACT

224-789-9601; alma.diaz@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: July 10, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)