Breast CarcinomaNCT06350500
A Patient Navigation Program for Addressing Disparities in Breast Cancer Care
A study testing Patient Navigation and Questionnaire in people with Breast Carcinoma and Breast Ductal Carcinoma in Situ, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Breast Ductal Carcinoma in Situ
- What is being tested?
- Patient Navigation and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2024to 15 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
ASK RPCI, 877-275-7724, askrpci@roswellpark.org
About this study
Official title: Addressing Disparities in Breast Cancer Care: An Approach to Health Equity
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Breast Carcinoma, Breast Ductal Carcinoma in Situ
- Being tested
- Patient Navigation, Questionnaire
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
Receive patient navigation
QuestionnaireOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Health Services Research (Patient Navigation) | Experimental | 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 Receives: Behavioral: Patient Navigation; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
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.
Measured: Up to 2 years
Reasons for refusal
Reported reasons of refusal will be summarized using frequencies and relative frequencies
Measured: Up to 2 years
Retention Rate
The number of patients that complete patient navigation divided by the number of patients enrolled
Measured: Up to 2 years
Reasons for discontinuation
Will be summarized using frequencies and relative frequencies
Measured: Up to 2 years
Secondary outcomes (5)
European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)
the quality of life in breast cancer patients. Score averaged, transformed to 0-100 scale, higher score indicates better quality of life
Measured: Up to 2 years
Social Determinates of health
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.
Measured: Up to 2 years
Barriers to care
Patient navigators will meet with participants to discuss barriers to care. Results will be summarized
Measured: Up to 2 years
Use of supportive services
Will be summarized using frequencies and relative frequencies
Measured: Up to 2 years
Patient Satisfaction survey
Will be summarized (by time as appropriate) using frequencies and relative frequencies
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start15 Dec 2024
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn Glaser, Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350500
- Sponsor's protocol ID
- I-3858823
- Status last verified
- Feb 2026
- First submitted
- 1 Apr 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Disparities in Breast Cancer Care: An Approach to Health Equity
- ClinicalTrials.gov ID
- NCT06350500
- Acronym / sponsor ID
- I-3858823
- Conditions
- Breast Carcinoma, Breast Ductal Carcinoma in Situ
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Services Research (Patient Navigation) | Experimental | Behavioral: Patient Navigation, Other: QuestionnairePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 must understand the investigational nature of this study and verbally consent to participate prior to receiving any study related intervention
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigationReceive patient navigation | Behavioural | Health Services Research (Patient Navigation) |
| QuestionnaireAncillary studies | Other | Health Services Research (Patient Navigation) |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathryn Glaser principal investigator
Roswell Park Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation and Questionnaire in people with Breast Carcinoma and Breast Ductal Carcinoma in Situ, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Glaser (716-845-7637, Kathryn.Glaser@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: Up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.