Clinical trial NCT04774445: Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes
Official title: Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Genetic Predisposition
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2021-03-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: The KnowGene Scale
timeFrame: Baseline - 18 Months
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline - 18 Months
Secondary outcomes:
measure: Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
timeFrame: Baseline - 18 Months
measure: Impact of Events Scale (IES)
timeFrame: Baseline - 18 months
measure: Test Result Recall
timeFrame: Baseline - 18 months
measure: Perceptions of Genetic Disease
timeFrame: Baseline - 18 months
measure: Behavioral Risk Factor Surveillance System Questionnaire (BRFSS)
timeFrame: Baseline - 18 months
measure: Health and Diet Survey Dietary Guidelines Supplement
timeFrame: Baseline - 18 months
measure: Sharing Genomic Information with Relatives (adapted from the PHENX Toolkit)
timeFrame: Baseline - 18 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center at the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Angela R Bradbury, MD
role: PRINCIPAL_INVESTIGATOR
References: