NCT06350500 · Roswell Park Cancer Institute
A Patient Navigation Program for Addressing Disparities in Breast Cancer Care
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Patient Navigation
Receive patient navigation
OTHER
Questionnaire
Ancillary studies
Primary outcome measures
Enrollment rate
Time frame: 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
Time frame: Up to 2 years
Reported reasons of refusal will be summarized using frequencies and relative frequencies
Retention Rate
Time frame: Up to 2 years
The number of patients that complete patient navigation divided by the number of patients enrolled
Reasons for discontinuation
Time frame: Up to 2 years
Will be summarized using frequencies and relative frequencies
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Buffalo, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations