A Patient Navigation Program for Addressing Disparities in Breast Cancer Care

NCT ID: NCT06350500

Last Updated: 2025-10-31

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

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2026-11-01

Brief Summary

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This clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. The navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. Offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients.

Detailed Description

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PRIMARY OBJECTIVE:

I. Implement a patient navigation program in the Roswell Park Breast Clinic focused on underserved women with a first cancer diagnosis of breast cancer or ductal carcinoma in situ (DCIS) (n=126).

SECONDARY OBJECTIVE:

I. Systematically address barriers to care by connecting women with multiple barriers of care with a first diagnosis of breast cancer or DCIS to supportive services and culturally appropriate resources.

Conditions

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Breast Carcinoma Breast Ductal Carcinoma in Situ

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Health Services Research (Patient Navigation)

Patients receive patient navigation services from a patient navigator as needed to improve knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance skills related to management of cancer treatment

Group Type EXPERIMENTAL

Patient Navigation

Intervention Type BEHAVIORAL

Receive patient navigation

Questionnaire

Intervention Type OTHER

Ancillary studies

Interventions

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Patient Navigation

Receive patient navigation

Intervention Type BEHAVIORAL

Questionnaire

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years of age
* Have a confirmed diagnosis of breast cancer or Ductal Carcinoma In Situ (DCIS)
* Currently identify their gender as woman or female
* Was assigned female sex at birth (AFAB)

\- Participant is experiencing ≥1 barrier to care as determined by the social needs screening tool
* Participant must understand the investigational nature of this study and verbally consent to participate prior to receiving any study related intervention

Exclusion Criteria

* Participants who are not suspected of or diagnosed with breast cancer or Ductal Carcinoma in Situ (DCIS)
* Participants who have had a previous diagnosis of any cancer
* Participants who were assigned male sex or intersex at birth
* Unwilling or unable to follow protocol requirements
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Glaser

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Comprehensive Cancer Center

Locations

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Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathryn Glaser

Role: CONTACT

716-845-7637

Facility Contacts

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ASK RPCI

Role: primary

877-275-7724

Other Identifiers

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I-3858823

Identifier Type: -

Identifier Source: org_study_id

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