Breast CancerNCT07781800
Navigation Interventions for Patients With Breast Cancer and High-risk Social Determinants of Health
A study testing Patient navigator in people with Breast Cancer and Cancer of Breast, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study aims to assess how individual patient social stressors are associated with barriers to care by analyzing a patient navigator system. Patient navigators will connect patients with unmet social needs with community resources. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer of Breast
- What is being tested?
- Patient navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2026to 31 Oct 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
Eligibility Criteria:
- Diagnosed with breast cancer (any stage).
- Currently being treated for breast cancer by a breast medical oncologist at Siteman Cancer Center North County. This includes any treatment, PO or IV, including hormonal therapy. It does not include patients enrolled in clinical trials.
- At least 18 years of age.
- English-speaker.
- Verbally consented to navigation services.
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
Washington University School of Medicine
St Louis, Missouri, 63310
Emily L Podany, MD, MPHS, 314-273-4474, elpodany@wustl.edu
Katherine N Weilbaecher, MD, 314-362-5654, kweilbae@wustl.edu
About this study
Official title: From Screening to Action: Implementing Navigation Interventions for Patients With Breast Cancer and High-risk Social Determinants of Health
This study aims to assess how individual patient social stressors are associated with barriers to care by analyzing a patient navigator system. Patient navigators will connect patients with unmet social needs with community resources.
- Conditions
- Breast Cancer, Cancer of Breast
- Being tested
- Patient navigator
- Keywords
- Patient navigation, Breast cancer, Social determinants of health, Navigator
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient navigatorBehavioural
Patient navigator will contact the patient every 3 weeks to check in, assess if patient requires additional resources, connect patient to existing nonprofit and local resources, remind patient of appointments, and ask about barriers to clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Patient navigation intervention | Experimental | Patients will be connected with a patient navigator following consent. The navigator will ask the patient questions regarding social determinants of health risks including transportation difficulties, financial stability, and housing stability. Patient will receive full social determinants of health (SDOH) screening via iPad at initial consult visit. Based on SDOH screening, if the patient is high risk the patient will be referred to appropriate resources. Receives: Behavioral: Patient navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with chemotherapy deferrals
Measured: 6 months
Secondary outcomes (2)
Rate of visit no-shows
Measured: 6 months
Rate of visit cancellations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start14 Oct 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Emily L Podany, MD, MPHS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781800
- Sponsor's protocol ID
- 202608090
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Screening to Action: Implementing Navigation Interventions for Patients With Breast Cancer and High-risk Social Determinants of Health
- ClinicalTrials.gov ID
- NCT07781800
- Acronym / sponsor ID
- 202608090
- Conditions
- Breast Cancer, Cancer of Breast
- Keywords
- Patient navigation, Breast cancer, Social determinants of health, Navigator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 14 Oct 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 24 Aug 2026 (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 study aims to assess how individual patient social stressors are associated with barriers to care by analyzing a patient navigator system. Patient navigators will connect patients with unmet social needs with community 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 |
|---|---|---|
| Patient navigation intervention | Experimental | Behavioral: Patient navigatorPatients will be connected with a patient navigator following consent. The navigator will ask the patient questions regarding social determinants of health risks including transportation difficulties, financial stability, and housing stability. Patient will receive full social determinants of health (SDOH) screening via iPad at initial consult visit. Based on SDOH screening, if the patient is high risk the patient will be referred to appropriate resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 navigatorPatient navigator will contact the patient every 3 weeks to check in, assess if patient requires additional resources, connect patient to existing nonprofit and local resources, remind patient of appointments, and ask about barriers to clinic visits. | Behavioural | Patient navigation intervention |
Primary outcome
Percentage of patients with chemotherapy deferrals
Time frame: 6 months
2 secondary outcomes
Rate of visit no-shows
Time frame: 6 months
Rate of visit cancellations
Time frame: 6 months
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 21 Oct 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Emily L Podany, MD, MPHS principal investigator
Washington University School of Medicine
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 navigator in people with Breast Cancer and Cancer of Breast, run by Washington University School of Medicine 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?
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 21 Oct 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 Emily L Podany, MD, MPHS (314-273-4474, elpodany@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with chemotherapy deferrals (time frame: 6 months). 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 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.