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

2488 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Patient Centered Clinical Decision Support (PC-CDS) for Breast and Ovarian Cancer Syndrome?

Research shows that Clinical Decision Support (CDS) systems can improve decision-making processes and patient outcomes in cancer care. In studies, CDS tools have been shown to enhance guideline adherence and patient-centered care, suggesting potential benefits for managing breast and ovarian cancer. ^{1 2 3 4 5}

Is the Clinical Decision Support for Breast and Ovarian Cancer Syndrome generally safe for humans?

The research articles discuss the management of adverse events in cancer treatments, highlighting the importance of monitoring and coordination to improve patient safety. However, they do not provide specific safety data for Clinical Decision Support systems like PC-CDS. ^{6 7 8 9 10}

How is the Patient Centered Clinical Decision Support (PC-CDS) treatment different from other treatments for breast and ovarian cancer syndrome?

The Patient Centered Clinical Decision Support (PC-CDS) treatment is unique because it uses a system to provide personalized treatment recommendations based on a patient's specific data, helping to guide decision-making in a more tailored way compared to traditional methods. This approach aims to improve both the decision-making process and patient outcomes by integrating clinical guidelines and patient-specific information. ^{1 3 4 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to address care gaps for participants at high risk of breast and ovarian cancer (HBOC), or Lynch syndrome (LS) because of testing positive for specific genetic variants. A patient-centered clinical decision support (PC-CDS) tool will help identify participants with genetic variations and display recommendations for referrals and testing to the clinician and participant at a primary care visit. The main question the study aims to answer is: - Does clinical decision support for participants with hereditary cancer syndromes improve the use of evidence-based cancer prevention care. Participants being seen in the PC-CDS group are compared to participants being seen in usual care (UC) to see if they are up to date on guideline-based cancer prevention care and to see if participants in the PC-CDS group report more shared decision making and higher rates of self-management of their genetic cancer risks. Participants will be asked to answer survey questions.

Research Team

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

Principal Investigator

HealthPartners Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Clinical decision support for therapeutic decision-making in cancer: A systematic review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Individualized survival curves improve satisfaction with cancer risk management decisions in women with BRCA1/2 mutations. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Understanding the engagement of key decision support persons in patient decision making around breast cancer treatment. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical Decision Support Systems Applied to the Management of Breast Cancer Patients: A Scoping Review. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of clinical decision support systems in oncology: An updated systematic review. [2023]

6. Canada 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. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Pharmaceutical care for patients with breast and ovarian cancer. [2022]

8. France pubmed.ncbi.nlm.nih.gov

[Impact of a coordinated regional organization to secure the management of patients on oral anticancer drugs: CHIMORAL, a comparative trial]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Algorithm-based decision support for symptom self-management among adults with Cancer: results of usability testing. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

A clinical decision support system learned from data to personalize treatment recommendations towards preventing breast cancer metastasis. [2020]