Breast CarcinomaNCT06950008
A Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer
A study testing Educational Intervention, Patient Navigation and Survey Administration in people with Breast Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies whether a patient navigation (PN) intervention can be used to improve risk management among women at high risk of breast cancer. Women with a family history of breast cancer have a higher lifetime risk of developing it. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Educational Intervention, Patient Navigation and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 31 Jan 2027
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are non-Hispanic Black or non-Hispanic white
- Identify as women
- Are between 18 and 75 years old
- Have been identified as at potentially high risk by a population-based risk screening program
- Have never been diagnosed with breast or ovarian cancer
- Are early in their risk-management adoption process, defined as currently identifying with stage 0 (never heard of it) or 1 (haven't decided) of the risk-management adoption pathway (R-MAP) in relation to at least one of the four risk-management actions recommended for all high-risk women: attending genetic counseling appointment, having a personalized risk assessment, undergoing annual clinical breast exams, and considering chemoprevention
- Who do not believe cancer can be prevented and/or have not received risk-management guidance from a specialist
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Feasibility Testing of a Patient Navigation Intervention to Improve Risk Management Among Women at High Risk of Breast Cancer
This clinical trial studies whether a patient navigation (PN) intervention can be used to improve risk management among women at high risk of breast cancer. Women with a family history of breast cancer have a higher lifetime risk of developing it. Risk management can benefit women at high risk of breast cancer and can include surveillance routines, preventative surgeries, and medications that can dramatically lower the risk of breast cancer and allow early detection. Although risk management can benefit women at high risk of breast cancer, only a small amount actually use it. PN is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN intervention in this study is designed to help give women the information and support they need to make choices about their breast cancer risk that they feel good about, which may improve risk management.
Read the detailed description
PRIMARY OBJECTIVE:
- Test the feasibility of the PN intervention and of recruiting participants to a randomized controlled trial of the intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive links to informational websites on breast cancer risk and risk management options on study. Participants also receive phone calls from a single patient navigator and discuss breast cancer risk and risk-management options once a month for 8 months. Participants may choose to receive additional patient navigator phone calls as needed on study.
ARM II: Participants receive links to informational websites on breast cancer risk and risk management options on study.
After completion of study intervention, participants are followed for up to 1 month.
- Conditions
- Breast Carcinoma
- Being tested
- Educational Intervention, Patient Navigation, Survey Administration, Telephone-Based Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive links to informational websites
Patient NavigationBehavioural
Also called Patient Navigator Program
Receive patient navigator phone calls
Survey AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive patient navigator phone calls
| Study group | Role | What they receive |
|---|---|---|
| Arm I (informational websites, PN) | Experimental | Participants receive links to informational websites on breast cancer risk and risk management options on study. Participants also receive phone calls from a single patient navigator and discuss breast cancer risk and risk-management options once a month for 8 months. Participants may choose to receive additional patient navigator phone calls as needed on study. Receives: Other: Educational Intervention; Behavioral: Patient Navigation; Other: Survey Administration; Behavioral: Telephone-Based Intervention |
| Arm II (informational websites) | Active comparator | Participants receive links to informational websites on breast cancer risk and risk management options on study. Receives: Other: Educational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant satisfaction with patient navigation (PN) intervention (Feasibility)
Will be measured using previously validated survey questions related to patient navigation interactions. Will be defined as at least 50% of intervention arm participants are "satisfied" or "very satisfied" with the PN intervention. Will be formally assessed using a point estimate and 95% one-sided (score-based) confidence interval.
Measured: Up to 9 months
Demand measures (Feasibility)
Measures the use of the patient navigator (PN). Will check that at least 50% of the sample interacted with the patient navigator for a total of at least 15 minutes.
Measured: Up to 9 months
Implementation of PN intervention (Feasibility)
Number of calls and patient navigator (PN contacts.
Measured: Up to 9 months
Practicality of PN intervention (Feasibility)
Percentage of participants that assess the intervention as appropriate and are willing to recommend it for similar others.
Measured: Up to 9 months
Percentage of recruited individuals who eventually enroll (Feasibility)
Will be tracked to help determine the feasibility of attracting appropriate sample sizes to power a later effectiveness-oriented randomized controlled trial. Recruitment success will be indicated by enrollment of ≥ 20% recruited patients and a total of 75 in 6 months. Point estimates for other key measures will be used as supporting evidence of intervention feasibility.
Measured: Up to 6 months
Risk-management adoption pathway (R-MAP) progress
Will descriptively estimate progress in R-MAP stage for each recommended risk-management action, as well as estimate change in other R-MAP measures between baseline and final surveys. Differences in R-MAP progress and other measures described will be estimated between arms at the final time point. Will regard the intervention as worthy of further effectiveness testing if the difference in R-MAP stage between intervention and control arm participants is ≥ .5 points (on the 6-point measurement scale) and ≥ 15% for at least one risk-management action.
Measured: Baseline up to 9 months
Perceived Breast Cancer Risk
The percentage of participants with perceived breast cancer risk indicated by survey responses will be summarized.
Measured: Up to 9 months
Cancer Worry
The percentage of participants with cancer worry indicated by survey responses will be summarized.
Measured: Up to 9 months
Confidence in Coping with Breast Cancer Risk
The percentage of participants with confidence in coping with breast cancer risk indicated by survey responses will be summarized.
Measured: Up to 9 months
Belief that Breast Cancer Risk can be Reduced
The percentage of participants with belief that their breast cancer risk can be reduced indicated by survey responses will be summarized.
Measured: Up to 9 months
Mental Health
Will be assessed via a 5-item inventory at baseline and final surveys.
Measured: Up to 9 months
Information usage (Self-reported)
Self-reported usage of the provided informational websites by the control group will be measured. Number of visits to the informational websites will be summarized.
Measured: Up to 9 months
Information usage (Machine-recorded)
Machine-recorded usage of the provided informational websites by the control group will be measured. Usage will be recorded by tracking the use of the bitly links provided. The number of visits to each informational website will be summarized.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Sep 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (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.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Tasleem Juana Padamsee, Ohio State University Comprehensive Cancer Center
- Investigators
- Tasleem J Padamsee, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950008
- Sponsor's protocol ID
- OSU-24198
- Other IDs
- NCI-2025-01592, R21CA271070
- Status last verified
- May 2026
- First submitted
- 26 Mar 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of a Patient Navigation Intervention to Improve Risk Management Among Women at High Risk of Breast Cancer
- ClinicalTrials.gov ID
- NCT06950008
- Acronym / sponsor ID
- OSU-24198
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 Apr 2025 (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 studies whether a patient navigation (PN) intervention can be used to improve risk management among women at high risk of breast cancer. Women with a family history of breast cancer have a higher lifetime risk of developing it. Risk management can benefit women at high risk of breast cancer and can include surveillance routines, preventative surgeries, and medications that can dramatically lower the risk of breast cancer and allow early detection. Although risk management can benefit women at high risk of breast cancer, only a small amount actually use it. PN is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN intervention in this study is designed to help give women the information and support they need to make choices about their breast cancer risk that they feel good about, which may improve risk management.
Detailed description
PRIMARY OBJECTIVE:
- Test the feasibility of the PN intervention and of recruiting participants to a randomized controlled trial of the intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive links to informational websites on breast cancer risk and risk management options on study. Participants also receive phone calls from a single patient navigator and discuss breast cancer risk and risk-management options once a month for 8 months. Participants may choose to receive additional patient navigator phone calls as needed on study.
ARM II: Participants receive links to informational websites on breast cancer risk and risk management options on study.
After completion of study intervention, participants are followed for up to 1 month.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (informational websites, PN) | Experimental | Other: Educational Intervention, Behavioral: Patient Navigation, Other: Survey Administration, Behavioral: Telephone-Based InterventionParticipants receive links to informational websites on breast cancer risk and risk management options on study. Participants also receive phone calls from a single patient navigator and discuss breast cancer risk and risk-management options once a month for 8 months. Participants may choose to receive additional patient navigator phone calls as needed on study. |
| Arm II (informational websites) | Active comparator | Other: Educational Intervention, Other: Survey AdministrationParticipants receive links to informational websites on breast cancer risk and risk management options on study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are non-Hispanic Black or non-Hispanic white
- Identify as women
- Are between 18 and 75 years old
- Have been identified as at potentially high risk by a population-based risk screening program
- Have never been diagnosed with breast or ovarian cancer
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive links to informational websites | Other | Arm I (informational websites, PN), Arm II (informational websites) |
| Patient NavigationAlso: Patient Navigator ProgramReceive patient navigator phone calls | Behavioural | Arm I (informational websites, PN) |
| Survey AdministrationAncillary studies | Other | Arm I (informational websites, PN), Arm II (informational websites) |
| Telephone-Based InterventionReceive patient navigator phone calls | Behavioural | Arm I (informational websites, PN) |
Primary outcome
Participant satisfaction with patient navigation (PN) intervention (Feasibility)
Time frame: Up to 9 months
Will be measured using previously validated survey questions related to patient navigation interactions. Will be defined as at least 50% of intervention arm participants are "satisfied" or "very satisfied" with the PN intervention. Will be formally assessed using a point estimate and 95% one-sided (score-based) confidence interval.
Demand measures (Feasibility)
Time frame: Up to 9 months
Measures the use of the patient navigator (PN). Will check that at least 50% of the sample interacted with the patient navigator for a total of at least 15 minutes.
Implementation of PN intervention (Feasibility)
Time frame: Up to 9 months
Number of calls and patient navigator (PN contacts.
Practicality of PN intervention (Feasibility)
Time frame: Up to 9 months
Percentage of participants that assess the intervention as appropriate and are willing to recommend it for similar others.
Percentage of recruited individuals who eventually enroll (Feasibility)
Time frame: Up to 6 months
Will be tracked to help determine the feasibility of attracting appropriate sample sizes to power a later effectiveness-oriented randomized controlled trial. Recruitment success will be indicated by enrollment of ≥ 20% recruited patients and a total of 75 in 6 months. Point estimates for other key measures will be used as supporting evidence of intervention feasibility.
Risk-management adoption pathway (R-MAP) progress
Time frame: Baseline up to 9 months
Will descriptively estimate progress in R-MAP stage for each recommended risk-management action, as well as estimate change in other R-MAP measures between baseline and final surveys. Differences in R-MAP progress and other measures described will be estimated between arms at the final time point. Will regard the intervention as worthy of further effectiveness testing if the difference in R-MAP stage between intervention and control arm participants is ≥ .5 points (on the 6-point measurement scale) and ≥ 15% for at least one risk-management action.
Perceived Breast Cancer Risk
Time frame: Up to 9 months
The percentage of participants with perceived breast cancer risk indicated by survey responses will be summarized.
Cancer Worry
Time frame: Up to 9 months
The percentage of participants with cancer worry indicated by survey responses will be summarized.
Confidence in Coping with Breast Cancer Risk
Time frame: Up to 9 months
The percentage of participants with confidence in coping with breast cancer risk indicated by survey responses will be summarized.
Belief that Breast Cancer Risk can be Reduced
Time frame: Up to 9 months
The percentage of participants with belief that their breast cancer risk can be reduced indicated by survey responses will be summarized.
Mental Health
Time frame: Up to 9 months
Will be assessed via a 5-item inventory at baseline and final surveys.
Information usage (Self-reported)
Time frame: Up to 9 months
Self-reported usage of the provided informational websites by the control group will be measured. Number of visits to the informational websites will be summarized.
Information usage (Machine-recorded)
Time frame: Up to 9 months
Machine-recorded usage of the provided informational websites by the control group will be measured. Usage will be recorded by tracking the use of the bitly links provided. The number of visits to each informational website will be summarized.
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 11 May 2026.
- The JameslineLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Tasleem J Padamsee, PhD principal investigator
Ohio State University 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 Educational Intervention, Patient Navigation and Survey Administration in people with Breast Carcinoma, run by Ohio State University Comprehensive Cancer Center 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 7 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 11 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant satisfaction with patient navigation (PN) intervention (Feasibility) (time frame: Up to 9 months). The study lists 13 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 11 May 2026.