Breast Cancer - Navigate - Prospective Cohort
- Conditions
- Quality of LifeChemotherapyBreast Cancer
- Interventions
- Behavioral: BC-Navigate
- Registration Number
- NCT06271356
- Lead Sponsor
- Northwestern University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BC-Navi BC-Navigate 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.
- Primary Outcome Measures
Name Time Method Demand of BC-Navi: Recruitment Rate 12 weeks 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.
Demand of BC-Navi: Retention Rate 12 weeks 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 .
Acceptability of BC-Navi 12 weeks 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.
Preliminary Efficacy: Chemotherapy Initiation 12 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Northwestern University
🇺🇸Chicago, Illinois, United States