Recruiting

Patient Navigation

Sponsor:

Roswell Park Cancer Institute

Code:

NCT06350500

Conditions

Breast Carcinoma

Breast Ductal Carcinoma in Situ

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient Navigation

Questionnaire

Study Details

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.

Conditions

Breast Carcinoma

Breast Ductal Carcinoma in Situ

Study ID

NCT06350500

Start date

Dec 15, 2024

Status verified date

Feb, 2026

Completion date

Mar 15, 2028

Anticipated

Primary completion date

Mar 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

126 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Health Services Research (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

Interventions

Patient Navigation

Receive patient navigation

Questionnaire

Ancillary studies

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kathryn Glaser

716-845-7637Kathryn.Glaser@roswellpark.org

Locations

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

Contacts

ASK RPCI

877-275-7724askrpci@roswellpark.org

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-02-17.