Clinical Decision Support for Breast and Ovarian Cancer Syndrome

(PC-CDS Trial)

Overseen By Heidi Ekstrom

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Dementia, Active cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve cancer prevention care for individuals at high risk of hereditary breast and ovarian cancer or Lynch syndrome, both linked to specific genetic traits. It tests a tool called Patient Centered Clinical Decision Support (PC-CDS), which aids doctors and patients in deciding on the best preventive actions by providing personalized advice during primary care visits. The trial compares two groups: one using the decision tool and one receiving standard care, to determine if the tool leads to better care practices and more informed patient choices. This study suits those with specific genetic markers for these conditions who aren't currently following all recommended preventive steps. Participants will need to complete surveys as part of the trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance preventive care for hereditary cancer risks.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on genetic testing and cancer prevention care, so it's best to discuss your medications with the trial team.

What prior data suggests that this clinical decision support tool is safe for use in managing hereditary cancer syndromes?

Research has shown that using a Patient Centered Clinical Decision Support (PC-CDS) tool is generally safe for participants. This tool aids doctors and patients in making informed decisions about cancer prevention by offering personalized advice based on genetic information. Previous studies have found that similar decision support systems are well-received by users. No significant reports of harm or serious side effects have emerged from using PC-CDS tools. These tools aim to enhance communication and decision-making, presenting a low-risk approach. Participants can feel confident that this method safely guides cancer prevention care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Centered Clinical Decision Support (PC-CDS) system because it provides personalized cancer prevention strategies for patients with Hereditary Breast and Ovarian Cancer Syndrome (HBOC) or Lynch Syndrome (LS). Unlike standard clinical decision support systems that offer general management of cardiovascular and chronic conditions, PC-CDS integrates patient-specific information to recommend tailored cancer prevention activities. This personalized approach aims to enhance early detection and prevention efforts, potentially leading to better outcomes for individuals at genetic risk for cancer.

What evidence suggests that this clinical decision support tool is effective for improving cancer prevention care in patients with hereditary cancer syndromes?

Research has shown that tools designed to support patient-centered clinical decisions can help identify individuals at high risk for breast and ovarian cancer. In this trial, participants in the "Patient Centered Clinical Decision Support for Hereditary Genetic Cancer Syndromes" arm will receive personalized cancer prevention advice based on their genetic information. Studies have found that these tools improve how patients with certain genetic conditions, such as Lynch syndrome (a disorder that increases cancer risk), manage their cancer risk. This approach ensures that patients and doctors follow best practices for cancer prevention. Overall, these tools effectively promote timely and guideline-based care for hereditary cancer syndromes. ^{1 2 3 6 7}

Who Is on the Research Team?

Patrick J. O'Connor, MD, MPH, MA

Principal Investigator

HealthPartners Institute

Are You a Good Fit for This Trial?

This trial is for individuals at high risk of hereditary breast and ovarian cancer or Lynch syndrome due to specific genetic variations. Participants should be visiting primary care and willing to use a clinical decision support tool during their visit.

Inclusion Criteria

Index clinical encounter is with a PCC (family practice, general internal medicine, nurse practitioner, or physician assistant) at a randomized primary care clinic during the accrual period

I have genetic proof of hereditary breast, ovarian cancer, or Lynch syndrome.

I have HBOC or LS and am not current with my cancer prevention care.

Exclusion Criteria

I am in long-term, palliative, or hospice care.

I have been diagnosed with dementia.

I am currently undergoing treatment for cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive patient-centered clinical decision support (PC-CDS) for hereditary cancer syndromes, including recommendations for cancer prevention care and referrals.

12 months

Regular primary care visits

Follow-up

Participants are monitored for shared decision making, self-efficacy, and resolution of care gaps related to hereditary cancer syndromes.

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Centered Clinical Decision Support (PC-CDS)

Trial Overview The study tests a Patient Centered Clinical Decision Support (PC-CDS) tool designed to help manage the risks associated with hereditary cancer syndromes by providing tailored recommendations for testing and referrals.

How Is the Trial Designed?

Group I: Patient Centered Clinical Decision Support for Hereditary Genetic Cancer Syndromes Experimental Treatment 1 Intervention

All patients and clinicians at PC-CDS clinics will continue to receive an existing EHR-linked clinical decision support for management of major uncontrolled cardiovascular risk factors and other selected chronic conditions plus patient-specific information on recommended cancer prevention activities for those with HBOC or LS.

Group II: Usual Care Active Control 1 Intervention

All patients and clinicians at UC clinics will continue to receive an existing EHR-linked clinical decision support for management of major uncontrolled cardiovascular risk factors and other selected chronic conditions. The existing CDS displayed at UC clinics does not include patient-specific information on recommended cancer prevention activities for those with HBOC or LS.

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A tailored decision support system (DSS) significantly improved decision satisfaction among women with BRCA1/2 mutations, with a notable increase in satisfaction scores after 6 weeks compared to a control group.

While the DSS did not reduce cancer anxiety or change management decisions, its effectiveness was particularly pronounced in women who initially had low levels of cancer-related anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized survival curves improve satisfaction with cancer risk management decisions in women with BRCA1/2 mutations. Armstrong, K., Weber, B., Ubel, PA., et al.[2006]

In a study of 2502 breast cancer patients and their decision support persons (DSPs), it was found that highly informed DSPs significantly improved patients' subjective decision quality, indicating that better-informed support can lead to better decision-making outcomes.

The study also revealed that DSPs who were more aware of patient preferences were associated with higher patient deliberation, suggesting that involving DSPs in the decision-making process can enhance the overall treatment experience for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the engagement of key decision support persons in patient decision making around breast cancer treatment. Veenstra, CM., Wallner, LP., Abrahamse, PH., et al.[2023]

A study involving 14 clinicians revealed that motivations for reporting serious oncology-associated adverse drug reactions included scientific curiosity and public health concerns, but feedback from pharmaceutical manufacturers was predominantly negative.

The research highlights the need for improved pharmacovigilance mechanisms, such as big data and registries, to enhance the reporting and documentation of adverse drug events, addressing barriers like complacency and indifference among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. Bennett, CL., Schooley, B., Taylor, MA., et al.[2020]

A 50-year-old breast cancer patient experienced significant adverse effects from tamoxifen, including hot flushes, hyperhidrosis, urinary frequency, and depression, which negatively impacted her quality of life.

After 25 days of treatment with traditional Korean herbal medicine and acupuncture, the patient's symptoms improved significantly, indicating that these interventions may help alleviate tamoxifen-induced side effects in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. Seo, J., Lee, D., Jo, HG.[2021]

The Decision Support System for Making Personalized Assessments and Recommendations Concerning Breast Cancer Patients (DPAC) effectively uses a Bayesian network to recommend optimal treatments, leading to significantly better 5-year metastasis-free probabilities for patients who followed its recommendations compared to those who did not.

In a 5-fold cross-validation, patients advised by DPAC had higher probabilities of being metastasis-free across various treatments, indicating its potential efficacy in guiding personalized breast cancer treatment, although some recommendations, like those regarding chemotherapy for node-negative patients, remain controversial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical decision support system learned from data to personalize treatment recommendations towards preventing breast cancer metastasis. Jiang, X., Wells, A., Brufsky, A., et al.[2020]

In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.

Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. Egbring, M., Far, E., Roos, M., et al.[2022]

A systematic review of 10 studies on clinical decision support (CDS) in cancer management found that CDS can significantly improve clinician decision-making processes in 5 out of 9 studies.

Among the studies measuring patient outcomes, 4 out of 6 showed significant improvements, indicating that CDS informed by clinical practice guidelines may enhance both decision-making and patient care in cancer settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support for therapeutic decision-making in cancer: A systematic review. Beauchemin, M., Murray, MT., Sung, L., et al.[2020]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11052525

Project Details To achieve this goal, we expand an existing, effective, patient-centered clinical decision support system to identify patients who have consented to genetic ...

2. trial.medpath.com trial.medpath.com/clinical-trial/cb0aa02063c8084a/nct06914726-trial-hereditary-cancer-syndromes

Patient Centered Clinical Decision Support for Hereditary ... A patient-centered clinical decision support (PC-CDS) tool will help identify participants with genetic variations and display recommendations for referrals and ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2794299

Patient and Clinician Decision Support to Increase Genetic ... This cluster randomized clinical trial investigates the effects of patient and clinician decision support for BRCA1/2 genetic testing ...

4. withpower.com withpower.com/trial/phase-ovarian-neoplasms-6-2025-af8e6

Clinical Decision Support for Breast and Ovarian Cancer ... A patient-centered clinical decision support (PC-CDS) tool will help identify participants with genetic variations and display recommendations for referrals and ...

5. ascopubs.org ascopubs.org/doi/10.1200/CCI.23.00024

Development of an Electronic Health Record–Based ... We have successfully developed an EHR-based CDS tool to promote guideline-recommended cancer risk management among patients with LS.

6. mdpi.com mdpi.com/2072-6694/15/2/391

MyLynch: A Patient-Facing Clinical Decision Support Tool ... MyLynch provides personalized cancer risk estimates and interventions to lower these risks for patients with LS. Abstract. Lynch syndrome (LS) is a hereditary ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35849397/

Patient and Clinician Decision Support to Increase Genetic ... This randomized clinical trial did not find a significant increase in genetic counseling uptake among patients who received patient and clinician decision ...