Clinical trial NCT06350500: A Patient Navigation Program for Addressing Disparities in Breast Cancer Care
Official title: Addressing Disparities in Breast Cancer Care: An Approach to Health Equity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Breast Ductal Carcinoma in Situ
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment rate
timeFrame: Up to 2 years
measure: Reasons for refusal
timeFrame: Up to 2 years
measure: Retention Rate
timeFrame: Up to 2 years
measure: Reasons for discontinuation
timeFrame: Up to 2 years
Secondary outcomes:
measure: European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)
timeFrame: Up to 2 years
measure: Social Determinates of health
timeFrame: Up to 2 years
measure: Barriers to care
timeFrame: Up to 2 years
measure: Use of supportive services
timeFrame: Up to 2 years
measure: Patient Satisfaction survey
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Roswell Park Comprehensive Cancer Center
name: Kathryn Glaser
role: PRINCIPAL_INVESTIGATOR
References: