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Breast Cancer - Navigate - Prospective Cohort

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06271356
Enrollment
64
Registered
2024-02-21
Start date
2024-07-10
Completion date
2025-09-01
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Chemotherapy, Quality of Life

Keywords

eHealth

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.

Interventions

BEHAVIORALBC-Navigate

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

Sponsors

Northwestern University
Lead SponsorOTHER
The Chrysalis Initiative
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Demand of BC-Navi: Recruitment Rate12 weeksWe 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.
Demand of BC-Navi: Retention Rate12 weeksAnother 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 .
Acceptability of BC-Navi12 weeksTo 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.
Preliminary Efficacy: Chemotherapy Initiation12 weeksPreliminary efficacy will be measured by time to chemotherapy initiation, which will be operationalized as chemotherapy treatment initiation within 90 days of completion of surgery.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026