A Patient Navigation Program for Addressing Disparities in Breast Cancer Care

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06350500
• Other study ID #: I-3858823
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: Roswell Park Cancer Institute
• Contact: Kathryn Glaser
• Phone: 716-845-7637
• Email: Kathryn.Glaser[@]roswellpark.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Ductal Carcinoma in Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Behavioral:
• Patient Navigation
Receive patient navigation

Other:
• Questionnaire
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 2 years
Primary	Reasons for refusal	Reported reasons of refusal will be summarized using frequencies and relative frequencies	Up to 2 years
Primary	Retention Rate	The number of patients that complete patient navigation divided by the number of patients enrolled	Up to 2 years
Primary	Reasons for discontinuation	Will be summarized using frequencies and relative frequencies	Up to 2 years
Secondary	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
Secondary	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
Secondary	Barriers to care	Patient navigators will meet with participants to discuss barriers to care. Results will be summarized	Up to 2 years
Secondary	Use of supportive services	Will be summarized using frequencies and relative frequencies	Up to 2 years
Secondary	Patient Satisfaction survey	Will be summarized (by time as appropriate) using frequencies and relative frequencies	up to 2 years