A Patient Navigation Program for Addressing Disparities in Breast Cancer Care
- Conditions
- Breast CarcinomaBreast Ductal Carcinoma in Situ
- Interventions
- Behavioral: Patient NavigationOther: Questionnaire
- Registration Number
- NCT06350500
- Lead Sponsor
- Roswell Park Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 126
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Health Services Research (Patient Navigation) Questionnaire 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 Health Services Research (Patient Navigation) 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
- Primary Outcome Measures
Name Time Method Retention Rate Up to 2 years The number of patients that complete patient navigation divided by the number of patients enrolled
Enrollment rate Up to 2 years 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.
Reasons for refusal Up to 2 years Reported reasons of refusal will be summarized using frequencies and relative frequencies
Reasons for discontinuation Up to 2 years Will be summarized using frequencies and relative frequencies
- Secondary Outcome Measures
Name Time Method Use of supportive services Up to 2 years Will be summarized using frequencies and relative frequencies
Social Determinates of health Up to 2 years 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.
European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30) Up to 2 years the quality of life in breast cancer patients. Score averaged, transformed to 0-100 scale, higher score indicates better quality of life
Patient Satisfaction survey up to 2 years Will be summarized (by time as appropriate) using frequencies and relative frequencies
Barriers to care Up to 2 years Patient navigators will meet with participants to discuss barriers to care. Results will be summarized
Trial Locations
- Locations (1)
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States