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Completed

NCT Number: NCT06271356

Breast Cancer - Navigate - Prospective Cohort

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chemotherapy Neoplasms Neoplasms by Site Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BC-Navigate

Behavioral

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

Primary outcomes

  1. Demand of BC-Navi: Recruitment Rate

    Time frame: 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.

  2. Demand of BC-Navi: Retention Rate

    Time frame: 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 .

  3. Acceptability of BC-Navi

    Time frame: 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.

  4. Preliminary Efficacy: Chemotherapy Initiation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • The Chrysalis Initiative

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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