Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes (MyCancerGene)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Genetic Predisposition
• Intervention / Treatment: Behavioral: MyCancerGene

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center at the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Individuals randomized to this arm will receive immediate access to the Interactive Health Communication Application.	Behavioral: MyCancerGene; Interactive Health Communication Application
No Intervention: Usual Care Group; Individuals randomized to this arm will receive the standard clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The KnowGene Scale	Change in Knowledge. Score Range = 0-16. Higher score = Better outcome	Baseline - 18 Months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)	Change in Uncertainty. Score Range = 0-85. Lower score = Better outcome	Baseline - 18 Months
Impact of Events Scale (IES)	Change in Disease-Specific Distress. Score Range =0-40. Lower score = Better outcome	Baseline - 18 months
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
Perceptions of Genetic Disease	Quantitative scales assessing changes in perceived risk, timeline and utility.	Baseline - 18 months
Behavioral Risk Factor Surveillance System Questionnaire (BRFSS)	Changes in modifiable cancer lifestyle behaviors. Yes/No responses.	Baseline - 18 months
Health and Diet Survey Dietary Guidelines Supplement	Changes in diet and exercise. Yes/No responses.	Baseline - 18 months
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

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Angela R Bradbury, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: UPCC 10919; 832628 (Other Identifier: University of Pennsylvania IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No