A Patient Navigation Program for Addressing Disparities in Breast Cancer Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient Navigation, Questionnaire.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma, Breast Ductal Carcinoma in Situ. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Addressing Disparities in Breast Cancer Care: An Approach to Health Equity
Overview
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.
Interventions
- Behavioral Patient Navigation
Receive patient navigation - Other Questionnaire
Ancillary studies
Primary outcome measures
- Enrollment rate [Time frame: Up to 2 years]
- Reasons for refusal [Time frame: Up to 2 years]
- Retention Rate [Time frame: Up to 2 years]
- Reasons for discontinuation [Time frame: Up to 2 years]
Secondary outcome measures (5)
- European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30) [Time frame: Up to 2 years]
- Social Determinates of health [Time frame: Up to 2 years]
- Barriers to care [Time frame: Up to 2 years]
- Use of supportive services [Time frame: Up to 2 years]
- Patient Satisfaction survey [Time frame: up to 2 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years of age
- Have a confirmed diagnosis of breast cancer or Ductal Carcinoma In Situ (DCIS)
- Currently identify their gender as woman or female
- Was assigned female sex at birth (AFAB)
\- Participant is experiencing ≥1 barrier to care as determined by the social needs screening tool
- Participant must understand the investigational nature of this study and verbally consent to participate prior to receiving any study related intervention
Exclusion criteria
- Participants who are not suspected of or diagnosed with breast cancer or Ductal Carcinoma in Situ (DCIS)
- Participants who have had a previous diagnosis of any cancer
- Participants who were assigned male sex or intersex at birth
- Unwilling or unable to follow protocol requirements
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Roswell Park Comprehensive Cancer Center — Buffalo
Identifiers
NCT: NCT06350500 · I-3858823