Genetics Advisor Decision Aid for Rare Cancers

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based tool called the Genetics Advisor Decision Aid, which assists patients with certain rare cancers in making decisions about their genomic test results. The tool guides participants in determining the type of genetic information they wish to receive from their tests. Participants are divided into two groups: one using the new online decision aid and another following the standard information process. The trial suits individuals diagnosed with cholangiocarcinoma or African Americans diagnosed with multiple myeloma or colorectal cancer. Participants must be able to use a computer, tablet, or smartphone. As an unphased trial, this study allows participants to contribute to innovative research that could improve decision-making tools for future patients.

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 prior data suggests that this web-based tool is safe for patient decision-making?

Research shows that the Genetics Advisor Decision Aid helps people understand and make decisions about their genetic test results. Studies have found this tool safe to use. In past research, users of similar tools did not report major issues or side effects. These tools are generally easy for patients to use. The main goal is to provide clear information and support for better understanding of genetic test results. As it is not a medicine, it doesn't carry the same safety concerns as drug treatments. Overall, it serves as a safe and helpful resource for making informed decisions about genetic information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Genetics Advisor Decision Aid because it offers personalized guidance for patients with rare cancers dealing with complex genetic information. Unlike standard materials that provide generic descriptions of genomic sequencing results, this tool aims to tailor information to each individual, potentially leading to better understanding and decision-making. By focusing on patient-specific data, it could empower patients and improve their engagement in their own care, which is a significant step forward from traditional methods.

What evidence suggests that the Genetics Advisor Decision Aid is effective for decision-making in rare cancers?

Studies have shown that the Genetics Advisor Decision Aid can help people make better choices about genetic testing. One study found that this tool significantly improved decision satisfaction among women with BRCA1/2 mutations, which are linked to certain cancers. Another study showed that while the tool did not reduce uncertainty compared to genetic counseling alone, patients still found the information helpful. In simple terms, the tool helps users understand their options and feel more confident in their choices about genetic results. This trial will compare the effectiveness of the Genetics Advisor Online Tool, provided to the intervention group, with standard developed materials given to the control group. This could be especially useful for those making decisions about rare cancers. ^{1 3 4 6 7}

Who Is on the Research Team?

Erin Linnenbringer, Ph.D., MS

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-multiple-myeloma-3-2025-6226b?condition=EBD+Cancer&overallStatus=Recruiting&hasNoPlacebo=false

Genetics Advisor Decision Aid for Rare Cancers A tailored decision support system (DSS) significantly improved decision satisfaction among women with BRCA1/2 mutations, with a notable increase in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7425118/

Effectiveness of the Genomics ADvISER decision aid for ... Our trial results found that the Genomics ADvISER did not decrease decisional conflict compared with genetic counseling alone, but patients who ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04725565

Genetics Adviser: Evaluating a Digital Decision Support ... The objective of this study is to evaluate the effectiveness of Genetics ADvISER in an RCT with patients being offered results from genomic sequencing. Results ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/12/4/e060899

Genetics Adviser: a protocol for a mixed-methods ... We aim to evaluate the effectiveness of the Genetics Adviser, an interactive, patient-facing, online digital health tool that delivers pre-test counselling, ...

5. academic.oup.com academic.oup.com/oncolo/article/29/5/e665/7595475

Development of an Electronic Decision Aid Tool to Facilitate ... The DA developed in this study has the potential to facilitate informed decision-making by patients regarding cancer genetic testing.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6018661/

The Genomics ADvISER: development and usability testing ... The Genomics ADvISER is a new patient-centered tool to support the clinical delivery of incidental GS results.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0738399120306029

A decision aid for additional findings in genomic sequencing The previously developed Genomics ADvISER decision aid provides guidance on five categories of additional findings (medically actionable, common disease risk, ...