A Patient Navigation Program for Addressing Disparities in Breast Cancer Care

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Carcinoma; Breast Ductal Carcinoma in Situ
• Intervention / Treatment: Other: Questionnaire; Behavioral: Patient Navigation

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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathryn Glaser; Phone Number: 716-845-7637; Email: kathryn.glaser@roswellpark.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years of age
• Have a confirmed diagnosis of breast cancer or DCIS
• Have not had a previous diagnosis of cancer
• Currently identify their gender as woman or female
• Was assigned female sex at birth (AFAB)
• Participant must understand the investigational nature of this study and verbally consent to participate prior to receiving any study related intervention

Exclusion Criteria:

• Participants under the age of 18
• Participants who are not suspected of or diagnosed with breast cancer or DCIS
• Participants who have had a previous diagnosis of any cancer
• Participants who identify their gender as other than woman or female
• Participants who were assigned male sex or intersex at birth
• Unwilling or unable to follow protocol requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Questionnaire; Ancillary studies; Behavioral: Patient Navigation; Receive patient navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Determinates of health	An 11 question survey . A score of 11 or more when the numerical values for answers to questions 7-10 are added shows that the person might not be safe.	Up to 2 years
Barriers to care	Patient navigators will meet with participants to discuss barriers to care. Results will be summarized	Up to 2 years
Use of supportive services	Will be summarized using frequencies and relative frequencies	Up to 2 years
Patient Satisfaction survey	Will be summarized (by time as appropriate) using frequencies and relative frequencies	up to 2 years
European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)	the quality of life in breast cancer patients. Score averaged, transformed to 0-100 scale, higher score indicates better quality of life	Up to 2 years

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Kathryn Glaser, Roswell Park Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ; Breast Neoplasms; Carcinoma; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast
• Other Study ID Numbers: I-3858823

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No