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NCT Number: NCT06350500

A Patient Navigation Program for Addressing Disparities in Breast Cancer Care

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.

Recruiting

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Key information

Conditions

Breast Carcinoma Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Ductal Carcinoma in Situ Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location status: Recruiting

Location contact

ASK RPCI

CONTACT

[email protected]

877-275-7724

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Navigation

Behavioral

Receive patient navigation

Questionnaire

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. Reasons for refusal

    Time frame: Up to 2 years

    Reported reasons of refusal will be summarized using frequencies and relative frequencies

  3. Retention Rate

    Time frame: Up to 2 years

    The number of patients that complete patient navigation divided by the number of patients enrolled

  4. Reasons for discontinuation

    Time frame: Up to 2 years

    Will be summarized using frequencies and relative frequencies

Secondary outcomes

  1. European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)

    Time frame: 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

  2. Social Determinates of health

    Time frame: 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.

  3. Barriers to care

    Time frame: Up to 2 years

    Patient navigators will meet with participants to discuss barriers to care. Results will be summarized

  4. Use of supportive services

    Time frame: Up to 2 years

    Will be summarized using frequencies and relative frequencies

  5. Patient Satisfaction survey

    Time frame: up to 2 years

    Will be summarized (by time as appropriate) using frequencies and relative frequencies

Study contacts

Contact information is provided by the study sponsor or research team.

Kathryn Glaser

CONTACT

[email protected]

716-845-7637

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

Addressing Disparities in Breast Cancer Care: An Approach to Health Equity

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 5, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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