Breast Cancer - Navigate - Prospective Cohort

NCT ID: NCT06271356

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-10

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Quality of Life Chemotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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BC-Navi

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.

Group Type EXPERIMENTAL

BC-Navigate

Intervention Type BEHAVIORAL

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

Interventions

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BC-Navigate

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Chrysalis Initiative

UNKNOWN

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Betina Yanez

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Betina Yanez

Role: CONTACT

312-503-5341

Alma Diaz

Role: CONTACT

224-789-9601

Facility Contacts

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Diana Buitrago

Role: primary

312-503-2866

Other Identifiers

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STU00220278

Identifier Type: -

Identifier Source: org_study_id

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