Breast Carcinoma
Conditions
Brief 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. 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: 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.
Interventions
OTHEREducational Intervention
Receive links to informational websites
BEHAVIORALPatient Navigation
Receive patient navigator phone calls
OTHERSurvey Administration
Ancillary studies
BEHAVIORALTelephone-Based Intervention
Receive patient navigator phone calls
Sponsors
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant satisfaction with patient navigation (PN) intervention (Feasibility) | 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) | 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) | Up to 9 months | Number of calls and patient navigator (PN contacts. |
| Practicality of PN intervention (Feasibility) | 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) | 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 | 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 | Up to 9 months | The percentage of participants with perceived breast cancer risk indicated by survey responses will be summarized. |
| Cancer Worry | 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 | 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 | 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 | Up to 9 months | Will be assessed via a 5-item inventory at baseline and final surveys. |
| Information usage (Self-reported) | 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) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTasleem J Padamsee, PhD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed