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Trial Title:
Breast Cancer - Navigate - Prospective Cohort
NCT ID:
NCT06271356
Condition:
Breast Cancer
Quality of Life
Chemotherapy
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
eHealth
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
BC-Navigate
Description:
BC-Navigate is a website/application to help guide women through care delivery during
breast cancer treatment.
Arm group label:
BC-Navi
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Diana Buitrago
Phone:
312-503-2866
Email:
diana.buitrago@northwestern.edu
Start date:
July 10, 2024
Completion date:
May 2025
Lead sponsor:
Agency:
Northwestern University
Agency class:
Other
Collaborator:
Agency:
The Chrysalis Initiative
Agency class:
Other
Source:
Northwestern University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06271356
