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NCT Number: NCT06950008

A Patient Navigation Intervention for the Improvement of 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

PRIMARY OBJECTIVE:

I. 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Treatment and study plan

Educational Intervention

Other

Receive links to informational websites

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Patient Navigation

Behavioral

Receive patient navigator phone calls

Other names: Patient Navigator Program

Survey Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Receive patient navigator phone calls

Primary outcomes

  1. 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.

  2. 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.

  3. Implementation of PN intervention (Feasibility)

    Time frame: Up to 9 months

    Number of calls and patient navigator (PN contacts.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Cancer Worry

    Time frame: Up to 9 months

    The percentage of participants with cancer worry indicated by survey responses will be summarized.

  9. 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.

  10. 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.

  11. Mental Health

    Time frame: Up to 9 months

    Will be assessed via a 5-item inventory at baseline and final surveys.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Feasibility Testing of a Patient Navigation Intervention to Improve Risk Management Among Women at High Risk of Breast Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2025
Registry last updated
May 11, 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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