Genetics Advisor Decision Aid for Rare Cancers

Overseen By Bettina Drake, Ph.D., MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Non-African American, Under 18, others

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

Compensation: Varies

Number of Visits: 3

240 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Genetics Advisor Decision Aid treatment for rare cancers?

The Genomics ADvISER decision aid has been shown to be effective in helping patients make informed decisions about genetic findings, as it improved knowledge and reduced decisional conflict in a clinical trial. Additionally, decision aids for women with BRCA mutations have been effective in improving satisfaction and decision-making regarding cancer risk management. ^{1 2 3 4 5}

What safety data exists for the Genetics Advisor Decision Aid for Rare Cancers?

The research highlights the use of patient forums to gather real-world data on side effects for rare cancer treatments, showing that forums can reveal side effects not found in initial trials, such as dry eyes and muscle cramping for imatinib. This suggests that real-world data can provide additional safety insights beyond traditional clinical trials. ^{6 7 8 9 10}

How is the Genetics Advisor Decision Aid treatment different from other treatments for rare cancers?

The Genetics Advisor Decision Aid is unique because it focuses on helping patients make informed decisions about genetic findings related to their cancer, rather than directly treating the cancer itself. It provides personalized information and support to guide patients through complex genetic information, which is not typically offered by standard cancer treatments. ^{1 2 3 4 11}

What is the purpose of this trial?

The overall goal of the randomized control trial (RCT) will be to evaluate the efficacy of modifications to a web-based tool for patient decision-making regarding return of genomic results that will more closely focus on rare cancers. Participants will be given access to a web-based decision aid (or a standard control) that guides participants in making decisions about what type of genomic results they would like to receive from testing performed in the PE-CGS study (NCT06340646).

Research Team

Erin Linnenbringer, Ph.D., MS

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for individuals with certain cancers (Multiple Myeloma, Cholangiocarcinoma, Colorectal Cancer, Bile Duct Cancer) who are making decisions about receiving genomic test results. Specific eligibility criteria details were not provided.

Inclusion Criteria

Able to understand an IRB-approved informed consent document and agree to participation

Have access to a personal computer, tablet, or mobile device

I am part of the WU-PE-CGS study and have been diagnosed with cholangiocarcinoma, multiple myeloma (if I am African American), or colorectal cancer (if I am African American and was 65 or older when diagnosed).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive either the expanded Genetics Advisor decision aid or standard developed materials

1 day

1 visit (virtual)

Follow-up

Participants are monitored for changes in knowledge, decisional conflict, and self-efficacy regarding genomic test results

3 months

2 assessments (virtual)

Treatment Details

Interventions

• Genetics Advisor Decision Aid

Trial Overview The study tests a web-based decision aid designed to help patients choose which genomic test results they want to receive. It's compared against standard materials in a randomized setup where participants are assigned by chance.

Participant Groups

Group I: Intervention: Genetics Advisor Online Tool Experimental Treatment 1 Intervention

The Intervention group will receive the expanded Genetics Advisor decision aid.

Group II: Control: Standard developed materials Active Control 1 Intervention

The control group will receive a description of each type of genomic sequencing result they could receive using the standard informed consent process for the return-of-results protocol.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

A longer decision aid (DA) for genetic testing in ovarian cancer patients significantly increased satisfaction (86% vs. 58%) and understanding compared to a shorter version, without increasing emotional distress.

74% of patients preferred the long DA, but older women and those currently undergoing treatment or experiencing recurrence showed a preference for the shorter DA, indicating that patient needs may vary based on their treatment status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision aids in mainstreaming genetic testing for women with ovarian cancer: A prospective cohort study. Sobocan, M., Chandrasekaran, D., Sideris, M., et al.[2023]

A new educational decision aid was developed for women who are carriers of pathogenic BRCA mutations to help them make informed choices about cancer risk management, ensuring it aligns with clinical guidelines and addresses psychosocial issues.

The decision aid was positively received in a pilot test with 23 participants, scoring above 3 on a scale of 1-4 for clarity and usefulness, indicating it effectively supports shared decision-making in cancer risk management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Testing of a Decision Aid for Unaffected Women with a BRCA1 or BRCA2 Mutation. Jabaley, T., Underhill-Blazey, ML., Berry, DL.[2021]

Patient forums can significantly enhance pharmacovigilance by providing real-time, uncensored reports of adverse drug events (ADEs) for rare cancers, as demonstrated in a case study on Gastrointestinal Stromal Tumor patients.

Using machine learning algorithms, the study identified that certain side effects, like cognitive impairment and alopecia from avapritinib, were reported at different rates compared to clinical trials, highlighting the potential of patient forums to uncover long-term and novel ADEs not previously documented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated gathering of real-world data from online patient forums can complement pharmacovigilance for rare cancers. Dirkson, A., Verberne, S., Kraaij, W., et al.[2022]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

A family-based reporting system for adverse events in pediatric inpatients did not significantly increase the reporting rates by healthcare providers, indicating a disconnect between family and staff perceptions of safety events.

Out of 321 events reported by families, 48% were legitimate safety concerns, highlighting that families can provide valuable insights into patient safety that are often overlooked by healthcare staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification by families of pediatric adverse events and near misses overlooked by health care providers. Daniels, JP., Hunc, K., Cochrane, DD., et al.[2022]

The FDA Adverse Event Reporting System (FAERS) is crucial for monitoring drug safety, but there has been a lack of systematic methods to compare adverse event rates across different drugs.

The study introduces a new statistical method that can effectively identify significant differences in adverse event rates among drugs while also estimating variations in age and gender distributions, enhancing the understanding of drug safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Different Adverse Effects Among Multiple Drugs Using FAERS Data. Huang, J., Zhang, X., Du, J., et al.[2021]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Patient decision aids in mainstreaming genetic testing for women with ovarian cancer: A prospective cohort study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Development and Testing of a Decision Aid for Unaffected Women with a BRCA1 or BRCA2 Mutation. [2021]

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

Effectiveness of the Genomics ADvISER decision aid for the selection of secondary findings from genomic sequencing: a randomized clinical trial. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

Development and testing of a decision aid for breast cancer prevention for women with a BRCA1 or BRCA2 mutation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Automated gathering of real-world data from online patient forums can complement pharmacovigilance for rare cancers. [2022]

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

The impact of minor adverse event tracking on subject safety: a web-based system. [2009]

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

Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve pediatric oncology care and research. [2020]

9. Canada pubmed.ncbi.nlm.nih.gov

Identification by families of pediatric adverse events and near misses overlooked by health care providers. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Comparing Different Adverse Effects Among Multiple Drugs Using FAERS Data. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Patient decision support resources inform decisions about cancer susceptibility genetic testing and risk management: a systematic review of patient impact and experience. [2023]