Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes

Cancer Clinical Trial

— MyCancerGene  

Official title:

Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04774445
• Other study ID #: UPCC 10919
• Secondary ID: 832628
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: April 1, 2026

Study information

• Verified date: July 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This protocol aims to evaluate the efficacy of a theoretically and stakeholder informed patient-centered genetic Interactive Health Communication Application to increase patient understanding of, and affective and behavioral responses to genetic testing. The study investigators hypothesize that the intervention will be associated with increases in knowledge, decreases in distress, increases in communication with relatives and health care providers, and increases in performance of risk reducing health behaviors.

Description:

As clinical practice increasingly use multi-gene testing, many patients are left with unknowns after genetic testing. Many have results that are unclear and may or may not be associated with any risk for cancer (Variants of Uncertain Significance), or mutations in genes with very limited information about disease risk or the best medical management. Importantly, many of these uncertainties will be clarified over time, but there is a need for effective ways of communicating these updates to patients who had testing months or years ago. In some cases, there may be multiple updates over time. To address this, this study will provide patients access, using an Interactive Health Communication Application, MyCancerGene, to information about their genetic testing, their specific results and the implications, the ability to print reports and other materials for their relatives and other health care providers and to assess if there has been a change in the personal or family history. Additionally, patients can contact their genetic provider through MyCancerGene and the cancer genetics team can send out updates to patients about their individual results or about new information about risk estimates or screening recommendations. The study investigators hypothesize that MyCancerGene will be associated with increases in knowledge, decreases in distress, increases in communication with relatives and health care providers, and increases in cancer screening and risk reducing health behaviors. After 12 months, all patients will have access to MyCancerGene, which will aid in understanding who benefits most and least from this intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older
• English Speaking
• Male or Female
• Internet and/or mobile access
• Previously received clinical genetic counseling and testing for hereditary cancer syndromes (up to 60 days prior to recruitment) Exclusion Criteria: •No internet and/or mobile access

Related Conditions & MeSH terms

• Cancer
• Genetic Predisposition
• Genetic Predisposition to Disease

Intervention

Behavioral:
• MyCancerGene
Interactive Health Communication Application

Locations

Country	Name	City	State
United States	Abramson Cancer Center at the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The KnowGene Scale	Change in Knowledge. Score Range = 0-16. Higher score = Better outcome	Baseline - 18 Months
Primary	Patient Reported Outcomes Measurement Information System (PROMIS)	Change in General Anxiety and Depression. Score Range = 4-20 for Anxiety/4-20 for Depression. Lower score = Better outcome	Baseline - 18 Months
Secondary	Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)	Change in Uncertainty. Score Range = 0-85. Lower score = Better outcome	Baseline - 18 Months
Secondary	Impact of Events Scale (IES)	Change in Disease-Specific Distress. Score Range =0-40. Lower score = Better outcome	Baseline - 18 months
Secondary	Test Result Recall	Single item assessing participants' ability to accurately recall their genetic test result. Single answer multiple choice: Positive, Negative, Variant of Uncertain Significance	Baseline - 18 months
Secondary	Perceptions of Genetic Disease	Quantitative scales assessing changes in perceived risk, timeline and utility.	Baseline - 18 months
Secondary	Behavioral Risk Factor Surveillance System Questionnaire (BRFSS)	Changes in modifiable cancer lifestyle behaviors. Yes/No responses.	Baseline - 18 months
Secondary	Health and Diet Survey Dietary Guidelines Supplement	Changes in diet and exercise. Yes/No responses.	Baseline - 18 months
Secondary	Sharing Genomic Information with Relatives (adapted from the PHENX Toolkit)	Assesses the number of relatives and health care providers patients share genetic test results with	Baseline - 18 months