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Trial Title:
A Patient Navigation Program for Addressing Disparities in Breast Cancer Care
NCT ID:
NCT06350500
Condition:
Breast Carcinoma
Breast Ductal Carcinoma in Situ
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Patient Navigation
Description:
Receive patient navigation
Arm group label:
Health Services Research (Patient Navigation)
Intervention type:
Other
Intervention name:
Questionnaire
Description:
Ancillary studies
Arm group label:
Health Services Research (Patient Navigation)
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
ASK RPCI
Phone:
877-275-7724
Email:
askrpci@roswellpark.org
Start date:
November 15, 2024
Completion date:
November 1, 2026
Lead sponsor:
Agency:
Roswell Park Cancer Institute
Agency class:
Other
Source:
Roswell Park Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06350500