A Patient Navigation Program for Addressing Disparities in Breast Cancer Care

Roswell Park Comprehensive Cancer Center

Status: Enrolling

Conditions: Breast Carcinoma; Breast Ductal Carcinoma in Situ

Treatments: Other: Questionnaire; Behavioral: Patient Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06350500

I-3858823

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 1 patient group

Health Services Research (Patient Navigation)

Experimental group

Description:

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

Treatment:

Behavioral: Patient Navigation

Other: Questionnaire