Breast CancerB-SINCERENCT06305312
Community Services Navigation to Advance Health Equity in Breast Cancer Screening
A study testing Community Service Navigation in people with Breast Cancer, run by University of Utah at 1 site in United States.
Trial summary
The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Community Service Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,450 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to Sep 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English and Spanish speakers
- Received an abnormal result of a screening mammogram
- Self-reports at least one social need on the B-SINCERE Screener
Who cannot join
- Patients who are currently in treatment for breast cancer
- Patients with a normal screening result.
- Patients who do not exhibit at least 1 social need according to their SINCERE screening result.
- Patients who don't speak English or Spanish
- Cognitive limitations that impede informed consent
- Patients living outside of Utah
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
University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences
Salt Lake City, Utah, 84112
Elissa Ozanne, PhD, 801-213-4130, Elissa.Ozanne@hsc.utah.edu
Tracy Onega, PhD
About this study
The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.
Read the detailed description
Disparities in breast cancer outcomes are persistent. In the United States, breast cancer is the most common, and second most deadly, cancer in women, with an estimated 281,550 new invasive breast cancer diagnoses and 43,600 breast cancer deaths in 2021. Underserved women, those who do not have adequate access to medical care, are represented disproportionately in those deaths, having lower incidence rates but higher mortality rates. While U.S. breast cancer mortality rates have decreased approximately 2% per year since 1990, socially and economically disadvantaged women have experienced increasing breast cancer mortality over that time. Rural women are more likely to experience diagnostic delays and are up to 1.5 times more likely to be diagnosed with advanced stages of disease compared with urban women.
Leveraging existing social systems for community navigation to facilitate breast screening follow-up. Our research has demonstrated that linkages between social needs screening in clinical settings and United Way 211's community referral service is possible using existing, low cost software solutions that can be adapted to clinical workflows. Specifically, the SINCERE 10-item social needs screener was combined with community services navigation and tested in a randomized controlled trial. That trial showed efficacy of the efficacy of this low cost, widely available solution to address the needs of vulnerable and underserved patients; namely, 211 active outreach v. passive information to address reported social needs. However, that trial was conducted in an Emergency Department, and has not been tested in other clinical settings. Building off of (collective) decades of work in breast cancer screening, the multiple PIs have formed an interdisciplinary team that has piloted an adaptation of the SINCERE social services screener (dubbed "B-SINCERE") in mammography clinics. This study will test the real-world efficacy (NIH stage 3) of the B-SINCERE community navigation intervention on increasing breast cancer screening episode completion. If efficacious, this intervention will be scalable with statewide community service providers and existing health information technology. Thus, the promise to make a real impact on early detection and improve breast cancer outcomes for underserved women with abnormal mammograms is the overarching driver of this work
- Conditions
- Breast Cancer
- Being tested
- Community Service Navigation, Usual Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Service NavigationBehavioural
Patients randomized to the intervention will be directly referred to the United Way of Salt Lake's 211 community referral service for additional outreach.
Usual CareOther
Standard referral to community resources.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Standard referrals to community resources will be used for participants randomized to usual care. Receives: Other: Usual Care |
| Intervention | Experimental | Community Services Navigation with 211 Information Specialists (ISs) will conduct outreach to participants within 48 hours of referral through telephone, text, or email, depending on patient preference. Two weeks after initial contact ISs follow up with patients to provide additional support and document use of the referred services in ServicePoint. Receives: Behavioral: Community Service Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Needs
Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener. To Test whether the use of a community services navigation intervention in conjunction with social service referrals decreases social needs compared to the referrals alone (usual care). B-SINCERE, reported on a 0-10 point scale, with 0=No Social Needs present, and 1-10=Social Needs present, anything greater than 0 indicates social needs and eligibility for the study.
Measured: up to 18 months after baseline assessment
Episode Completion (EC).
EC is the name of a dichotomous scale, reported on a 2-point scale that is calculated from patient electronic health record (EHR), with 0=No Breast Cancer Screening completed, 1=Breast Cancer Screening completed.
Impact of the community services navigation intervention on breast cancer screening episode completion and preventive care utilization among women with self-reported social needs. Preventive Care Utilization is a descriptive measure that is not reporting a score on a scale.
Measured: up to 18 months after baseline assessment
Secondary outcomes (10)
Area deprivation index (ADI)
DI is a tool for assessing an area's socioeconomic conditions. Scores range from 1-100, with lower scores indicating minimal socioeconomic disadvantage and higher scores indicating more socioeconomic disadvantage. This outcome measure will report ADI at 6 and 18 months of rural vs urban participants (based on ZIP codes) after baseline.
Measured: up to 18 months after baseline assessment
Rural Urban Commuting Area (RUCA)
RUCA assesses urbanization, population density, and commuting. Scores range from 1 to 10, with lower scores indicating more urban areas and higher scores representing more rural areas. This outcome measure will report RUCA at 6 and 18 months of rural vs urban participants (based on ZIP codes) after baseline.
Measured: up to 18 months after baseline assessment
Social Service Utilization
Social Service Utilization will assess how many study participants utilize 211 social services. This outcome measure will report the proportion of participants utilizing the following 211 medical care services: Finding healthy food, Adult education/job training/employment, Clothing/supplies, Housing, Transportation, Paying for health care, Paying bills, Child care, Other, 211 didn't help me get any services. This outcome measure will report social service utilization at 1, 6, and 18 months after the baseline assessment.
Measured: up to 18 months after baseline assessment
Breast cancer risk (Tyrer-Cuzick)
The Tyrer-Cuzick breast cancer risk score estimates the likelihood of developing breast cancer. Scores range from 0 to 100 with lower scores indicating low breast cancer risk and high scores indicating high breast cancer risk. This outcome measure will report the mean breast cancer risk score at 6 and 18 months after the baseline assessment.
Measured: up to 18 months after baseline assessment
General Health Status
General Health Status is a scale assessing general health. Scores range from 0 to 5, with lower scores indicating better health and higher scores indicating worse health. This outcome measure will report General Health Status at 1, 6, and 18 months after the baseline assessment.
Measured: up to 18 months after baseline assessment
Self-Report Generated Charlson Comorbidity Index
Charlson Comorbidity Index is a score predicting mortality risk based on comorbidities. Scores range from 1 to 37, with lower scores indicating better mortality risk and higher scores representing worse mortality risk.
This outcome measure will report the mean Charlson Comorbidity Index at 6 and 18 months after the baseline assessment.
Measured: up to 18 months after baseline assessment
Preventive services visits
Preventive services visits will measure how many participants complete their preventive visits. This outcome measure will report the proportion of participants who completed preventive visits such as the next annual mammogram, cervical cancer screening, or colorectal cancer screening. This outcome measure will report the proportion completing preventive services visits at 1, 6, and 18 months after the baseline assessment.
Measured: from baseline assessment, up to 18 months
PROMIS Global Health
PROMIS Global Health is a questionnaire assessing participants' health. Scores range from 0 to 32, with lower scores indicating worse health and higher scores indicating better health. This outcome measure will report PROMIS Global Health at 1, 6, and 18 months after the baseline assessment.
Measured: up to 18 months after baseline assessment
PROMIS Depression
PROMIS Depression is a questionnaire assessing participants' mental health. Scores range from 0 to 32, with lower scores indicating better mental health and higher scores indicating worse mental health. This outcome measure will report PROMIS Depression at 1, 6, and 18 months after the baseline assessment.
Measured: up to 18 months after baseline assessment
Health Care Access
Healthcare access is a 4-item questionnaire assessing patients' access to healthcare. Scores range from 0-12, with lower scores indicating worse access to healthcare and higher scores indicating better access to healthcare. This outcome measure will report Health Care Access at 6 and 18 months after the baseline assessment.
Measured: up to 18 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start30 Apr 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (99)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elissa Ozanne, PhD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305312
- Sponsor's protocol ID
- HCI166685
- Other IDs
- 1R01CA282409-01
- Acronym
- B-SINCERE
- Status last verified
- Jul 2025
- First submitted
- 29 Feb 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cancer Stat Facts: Female Breast Cancer. 2022; https://seer.cancer.gov/statfacts/html/breast.html. Accessed Jul 11, 2022.
Underserved group. Toolkit for Patient-Focused Therapy Development https://toolkit.ncats.nih.gov/glossary/underserved-group/. Accessed September 30, 2022.
American Cancer Society. Cancer Facts & Figures for Hispanics/Latinos 2018-2020. Atlanta2018.
Centers for Disease Control and Prevention National Center for Health Statistics. Death Rates for Selected Cancers by Race and Ethnicity, US, 2010-2014. 2016; https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/death-rates-for-selected-cancers-by-race-and-ethnicity-us-2010-2014.pdf. Accessed Oct 11, 2021.
Zahnd WE, James AS, Jenkins WD, Izadi SR, Fogleman AJ, Steward DE, Colditz GA, Brard L. Rural-Urban Differences in Cancer Incidence and Trends in the United States. Cancer Epidemiol Biomarkers Prev. 2018 Nov;27(11):1265-1274. doi: 10.1158/1055-9965.EPI-17-0430. Epub 2017 Jul 27.
PubMed 28751476Death Rates for Selected Cancers by Race and Ethnicity, US, 2010-2014. 2016; https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/death-rates-for-selected-cancers-by-race-and-ethnicity-us-2010-2014.pdf. Accessed Oct 11, 2021.
Henry KA, Sherman R, Farber S, Cockburn M, Goldberg DW, Stroup AM. The joint effects of census tract poverty and geographic access on late-stage breast cancer diagnosis in 10 US States. Health Place. 2013 May;21:110-21. doi: 10.1016/j.healthplace.2013.01.007. Epub 2013 Mar 1.
PubMed 23454732DeSantis CE, Ma J, Goding Sauer A, Newman LA, Jemal A. Breast cancer statistics, 2017, racial disparity in mortality by state. CA Cancer J Clin. 2017 Nov;67(6):439-448. doi: 10.3322/caac.21412. Epub 2017 Oct 3.
PubMed 28972651Doescher MP, Jackson JE. Trends in cervical and breast cancer screening practices among women in rural and urban areas of the United States. J Public Health Manag Pract. 2009 May-Jun;15(3):200-9. doi: 10.1097/PHH.0b013e3181a117da.
PubMed 19363399Roche LM, Niu X, Stroup AM, Henry KA. Disparities in Female Breast Cancer Stage at Diagnosis in New Jersey: A Spatial-Temporal Analysis. J Public Health Manag Pract. 2017 Sep/Oct;23(5):477-486. doi: 10.1097/PHH.0000000000000524.
PubMed 28430705Williams F, Jeanetta S, O'Brien DJ, Fresen JL. Rural-urban difference in female breast cancer diagnosis in Missouri. Rural Remote Health. 2015 Jul-Sep;15(3):3063. Epub 2015 Jul 29.
PubMed 26223824Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoecon Outcomes Res. 2018 Mar 26;10:157-167. doi: 10.2147/CEOR.S150260. eCollection 2018.
PubMed 29618934Bleicher RJ. Timing and Delays in Breast Cancer Evaluation and Treatment. Ann Surg Oncol. 2018 Oct;25(10):2829-2838. doi: 10.1245/s10434-018-6615-2. Epub 2018 Jul 2.
PubMed 29968031Bleicher RJ, Ruth K, Sigurdson ER, Ross E, Wong YN, Patel SA, Boraas M, Topham NS, Egleston BL. Preoperative delays in the US Medicare population with breast cancer. J Clin Oncol. 2012 Dec 20;30(36):4485-92. doi: 10.1200/JCO.2012.41.7972. Epub 2012 Nov 19.
PubMed 23169513Bradley CJ, Given CW, Roberts C. Disparities in cancer diagnosis and survival. Cancer. 2001 Jan 1;91(1):178-88. doi: 10.1002/1097-0142(20010101)91:13.0.co;2-s.
PubMed 11148575
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Services Navigation to Advance Health Equity in Breast Cancer Screening
- ClinicalTrials.gov ID
- NCT06305312
- Acronym / sponsor ID
- B-SINCERE / HCI166685
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,450 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 12 Mar 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.
The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.
Detailed description
Disparities in breast cancer outcomes are persistent. In the United States, breast cancer is the most common, and second most deadly, cancer in women, with an estimated 281,550 new invasive breast cancer diagnoses and 43,600 breast cancer deaths in 2021. Underserved women, those who do not have adequate access to medical care, are represented disproportionately in those deaths, having lower incidence rates but higher mortality rates. While U.S. breast cancer mortality rates have decreased approximately 2% per year since 1990, socially and economically disadvantaged women have experienced increasing breast cancer mortality over that time. Rural women are more likely to experience diagnostic delays and are up to 1.5 times more likely to be diagnosed with advanced stages of disease compared with urban women.
Leveraging existing social systems for community navigation to facilitate breast screening follow-up. Our research has demonstrated that linkages between social needs screening in clinical settings and United Way 211's community referral service is possible using existing, low cost software solutions that can be adapted to clinical workflows. Specifically, the SINCERE 10-item social needs screener was combined with community services navigation and tested in a randomized controlled trial. That trial showed efficacy of the efficacy of this low cost, widely available solution to address the needs of vulnerable and underserved patients; namely, 211 active outreach v. passive information to address reported social needs. However, that trial was conducted in an Emergency Department, and has not been tested in other clinical settings. Building off of (collective) decades of work in breast cancer screening, the multiple PIs have formed an interdisciplinary team that has piloted an adaptation of the SINCERE social services screener (dubbed "B-SINCERE") in mammography clinics. This study will test the real-world efficacy (NIH stage 3) of the B-SINCERE community navigation intervention on increasing breast cancer screening episode completion. If efficacious, this intervention will be scalable with statewide community service providers and existing health information technology. Thus, the promise to make a real impact on early detection and improve breast cancer outcomes for underserved women with abnormal mammograms is the overarching driver of this work
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareStandard referrals to community resources will be used for participants randomized to usual care. |
| Intervention | Experimental | Behavioral: Community Service NavigationCommunity Services Navigation with 211 Information Specialists (ISs) will conduct outreach to participants within 48 hours of referral through telephone, text, or email, depending on patient preference. Two weeks after initial contact ISs follow up with patients to provide additional support and document use of the referred services in ServicePoint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English and Spanish speakers
- Received an abnormal result of a screening mammogram
- Self-reports at least one social need on the B-SINCERE Screener
Key exclusion criteria (6 listed)
- Patients who are currently in treatment for breast cancer
- Patients with a normal screening result.
- Patients who do not exhibit at least 1 social need according to their SINCERE screening result.
- Patients who don't speak English or Spanish
- Cognitive limitations that impede informed consent
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 |
|---|---|---|
| Community Service NavigationPatients randomized to the intervention will be directly referred to the United Way of Salt Lake's 211 community referral service for additional outreach. | Behavioural | Intervention |
| Usual CareStandard referral to community resources. | Other | Usual Care |
Primary outcome
Change in Social Needs
Time frame: up to 18 months after baseline assessment
Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener. To Test whether the use of a community services navigation intervention in conjunction with social service referrals decreases social needs compared to the referrals alone (usual care). B-SINCERE, reported on a 0-10 point scale, with 0=No Social Needs present, and 1-10=Social Needs present, anything greater than 0 indicates social needs and eligibility for the study.
Episode Completion (EC).
Time frame: up to 18 months after baseline assessment
EC is the name of a dichotomous scale, reported on a 2-point scale that is calculated from patient electronic health record (EHR), with 0=No Breast Cancer Screening completed, 1=Breast Cancer Screening completed. Impact of the community services navigation intervention on breast cancer screening episode completion and preventive care utilization among women with self-reported social needs. Preventive Care Utilization is a descriptive measure that is not reporting a score on a scale.
10 secondary outcomes
Area deprivation index (ADI)
Time frame: up to 18 months after baseline assessment
Rural Urban Commuting Area (RUCA)
Time frame: up to 18 months after baseline assessment
Social Service Utilization
Time frame: up to 18 months after baseline assessment
Breast cancer risk (Tyrer-Cuzick)
Time frame: up to 18 months after baseline assessment
General Health Status
Time frame: up to 18 months after baseline assessment
Self-Report Generated Charlson Comorbidity Index
Time frame: up to 18 months after baseline assessment
Preventive services visits
Time frame: from baseline assessment, up to 18 months
PROMIS Global Health
Time frame: up to 18 months after baseline assessment
PROMIS Depression
Time frame: up to 18 months after baseline assessment
Health Care Access
Time frame: up to 18 months after baseline assessment
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 1 Aug 2025.
- BackgroundCancer Stat Facts: Female Breast Cancer. 2022; https://seer.cancer.gov/statfacts/html/breast.html. Accessed Jul 11, 2022.
- BackgroundUnderserved group. Toolkit for Patient-Focused Therapy Development https://toolkit.ncats.nih.gov/glossary/underserved-group/. Accessed September 30, 2022.
- BackgroundAmerican Cancer Society. Cancer Facts & Figures for Hispanics/Latinos 2018-2020. Atlanta2018.
- BackgroundCenters for Disease Control and Prevention National Center for Health Statistics. Death Rates for Selected Cancers by Race and Ethnicity, US, 2010-2014. 2016; https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/death-rates-for-selected-cancers-by-race-and-ethnicity-us-2010-2014.pdf. Accessed Oct 11, 2021.
- Background: PubMed 28751476Zahnd WE, James AS, Jenkins WD, Izadi SR, Fogleman AJ, Steward DE, Colditz GA, Brard L. Rural-Urban Differences in Cancer Incidence and Trends in the United States. Cancer Epidemiol Biomarkers Prev. 2018 Nov;27(11):1265-1274. doi: 10.1158/1055-9965.EPI-17-0430. Epub 2017 Jul 27.
- BackgroundDeath Rates for Selected Cancers by Race and Ethnicity, US, 2010-2014. 2016; https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/death-rates-for-selected-cancers-by-race-and-ethnicity-us-2010-2014.pdf. Accessed Oct 11, 2021.
- Background: PubMed 23454732Henry KA, Sherman R, Farber S, Cockburn M, Goldberg DW, Stroup AM. The joint effects of census tract poverty and geographic access on late-stage breast cancer diagnosis in 10 US States. Health Place. 2013 May;21:110-21. doi: 10.1016/j.healthplace.2013.01.007. Epub 2013 Mar 1.
- Background: PubMed 28972651DeSantis CE, Ma J, Goding Sauer A, Newman LA, Jemal A. Breast cancer statistics, 2017, racial disparity in mortality by state. CA Cancer J Clin. 2017 Nov;67(6):439-448. doi: 10.3322/caac.21412. Epub 2017 Oct 3.
- Background: PubMed 19363399Doescher MP, Jackson JE. Trends in cervical and breast cancer screening practices among women in rural and urban areas of the United States. J Public Health Manag Pract. 2009 May-Jun;15(3):200-9. doi: 10.1097/PHH.0b013e3181a117da.
- Background: PubMed 28430705Roche LM, Niu X, Stroup AM, Henry KA. Disparities in Female Breast Cancer Stage at Diagnosis in New Jersey: A Spatial-Temporal Analysis. J Public Health Manag Pract. 2017 Sep/Oct;23(5):477-486. doi: 10.1097/PHH.0000000000000524.
- Background: PubMed 26223824Williams F, Jeanetta S, O'Brien DJ, Fresen JL. Rural-urban difference in female breast cancer diagnosis in Missouri. Rural Remote Health. 2015 Jul-Sep;15(3):3063. Epub 2015 Jul 29.
- Background: PubMed 29618934Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoecon Outcomes Res. 2018 Mar 26;10:157-167. doi: 10.2147/CEOR.S150260. eCollection 2018.
- 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.
Elissa Ozanne, PhD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Service Navigation in people with Breast Cancer, run by University of Utah 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 3 inclusion and 6 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 1 Aug 2025. 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 Elissa Ozanne, PhD (801-213-4130, Elissa.Ozanne@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social Needs (time frame: up to 18 months after baseline assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06305312, which also lists 99 linked publications.
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 1 Aug 2025.