Clinical trial NCT06271356: Breast Cancer - Navigate - Prospective Cohort
Official title: Effect of a Navigation Intervention on Care Equity for Women of Color Diagnosed With Breast Cancer: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Quality of Life
Chemotherapy
Keywords: eHealth
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: The Chrysalis Initiative
First posted: 2024-02-21
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Demand of BC-Navi: Recruitment Rate
timeFrame: 12 weeks
measure: Demand of BC-Navi: Retention Rate
timeFrame: 12 weeks
measure: Acceptability of BC-Navi
timeFrame: 12 weeks
measure: Preliminary Efficacy: Chemotherapy Initiation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: