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Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes (MyCancerGene)

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ClinicalTrials.gov Identifier: NCT04774445
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Genetic Predisposition Behavioral: MyCancerGene Not Applicable

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 18 months, all patients will have access to MyCancerGene, which will aid in understanding who benefits most and least from this intervention.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes
Actual Study Start Date : May 3, 2021
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The KnowGene Scale [ Time Frame: Baseline - 24 Months ]
    Change in Knowledge. Score Range = 0-16. Higher score = Better outcome

  2. Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline - 24 Months ]
    Change in General Anxiety and Depression. Score Range = 4-20 for Anxiety/4-20 for Depression. Lower score = Better outcome


Secondary Outcome Measures :
  1. Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) [ Time Frame: Baseline - 24 Months ]
    Change in Uncertainty. Score Range = 0-85. Lower score = Better outcome

  2. Impact of Events Scale (IES) [ Time Frame: Baseline - 24 months ]
    Change in Disease-Specific Distress. Score Range =0-40. Lower score = Better outcome

  3. Test Result Recall [ Time Frame: Baseline - 24 months ]
    Single item assessing participants' ability to accurately recall their genetic test result. Single answer multiple choice: Positive, Negative, Variant of Uncertain Significance

  4. Perceptions of Genetic Disease [ Time Frame: Baseline - 24 months ]
    Quantitative scales assessing changes in perceived risk, timeline and utility.

  5. Behavioral Risk Factor Surveillance System Questionnaire (BRFSS) [ Time Frame: Baseline - 24 months ]
    Changes in modifiable cancer lifestyle behaviors. Yes/No responses.

  6. Health and Diet Survey Dietary Guidelines Supplement [ Time Frame: Baseline - 24 months ]
    Changes in diet and exercise. Yes/No responses.

  7. Sharing Genomic Information with Relatives (adapted from the PHENX Toolkit) [ Time Frame: Baseline - 24 months ]
    Assesses the number of relatives and health care providers patients share genetic test results with


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774445


Contacts
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Contact: Angela R Bradbury, MD 215 615 3341 Angela.Bradbury@pennmedicine.upenn.edu
Contact: Dominique Fetzer, BA 215 662 2753 Dominique.Fetzer@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Abramson Cancer Center at the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Angela Bradbury, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
American Cancer Society, Inc.
Investigators
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Principal Investigator: Angela R Bradbury, MD University of Pennsylvania
More Information
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04774445    
Other Study ID Numbers: 832628
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes