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RecruitingInterventional

Addressing Disparities in Breast Cancer Care: An Approach to Health Equity

NCT ID: NCT06350500Sponsor: Roswell Park Cancer InstituteLast updated: 2026-02-17

Summary

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

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.

Arms & interventions

  • BehavioralPatient Navigation

    Receive patient navigation

  • OtherQuestionnaire

    Ancillary studies

Outcome measures

Primary

  • Enrollment rate

    Enrollment rate Will be defined as the number of patients enrolled divided by the number of patients approached. The enrollment rate will be estimated with a 90% credible region obtained by Jeffrey's prior method.

    Time frame: Up to 2 years

  • Reasons for refusal

    Reported reasons of refusal will be summarized using frequencies and relative frequencies

    Time frame: Up to 2 years

  • Retention Rate

    The number of patients that complete patient navigation divided by the number of patients enrolled

    Time frame: Up to 2 years

  • Reasons for discontinuation

    Will be summarized using frequencies and relative frequencies

    Time frame: Up to 2 years

Secondary

  • European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)

    Time frame: Up to 2 years

  • Social Determinates of health

    Time frame: Up to 2 years

  • Barriers to care

    Time frame: Up to 2 years

  • Use of supportive services

    Time frame: Up to 2 years

  • Patient Satisfaction survey

    Time frame: up to 2 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

Recruiting
ASK RPCI · Contact
877-275-7724askrpci@roswellpark.org