A Patient Navigation Program for Addressing Disparities in Breast Cancer Care

NCT06350500 | Recruiting

• 1 other identifier: I-3858823
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Carcinoma; Breast Ductal Carcinoma in Situ

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to 2 years

• Reasons for refusal

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

  Up to 2 years

• Retention Rate

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

  Up to 2 years

• Reasons for discontinuation

  Will be summarized using frequencies and relative frequencies

  Up to 2 years

Secondary Outcomes (5)

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

  Up to 2 years

• Social Determinates of health

  Up to 2 years

• Barriers to care

  Up to 2 years

• Use of supportive services

  Up to 2 years

• Patient Satisfaction survey

  up to 2 years

Study Arms (1)

Health Services Research (Patient Navigation)

EXPERIMENTAL

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

Behavioral: Patient Navigation; Other: Questionnaire

Interventions

Patient Navigation BEHAVIORAL

Receive patient navigation

Health Services Research (Patient Navigation)

Questionnaire OTHER

Ancillary studies

Health Services Research (Patient Navigation)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Interventions

Patient Navigation; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kathryn Glaser

  Roswell Park Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Glaser

CONTACT

716-845-7637; Kathryn.Glaser@roswellpark.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)