Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes
MyCancerGene
2 other identifiers
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started May 2021
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedStudy Start
First participant enrolled
May 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedFebruary 10, 2025
October 1, 2024
4 years
February 18, 2021
February 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
Baseline - 18 Months
Impact of Events Scale (IES)
Baseline - 18 months
Test Result Recall
Baseline - 18 months
Perceptions of Genetic Disease
Baseline - 18 months
Behavioral Risk Factor Surveillance System Questionnaire (BRFSS)
Baseline - 18 months
- +2 more secondary outcomes
Study Arms (2)
Intervention Group
EXPERIMENTALIndividuals randomized to this arm will receive immediate access to the Interactive Health Communication Application.
Usual Care Group
NO INTERVENTIONIndividuals randomized to this arm will receive the standard clinical practice.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- No internet and/or mobile access
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela R Bradbury, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2021
First Posted
March 1, 2021
Study Start
May 3, 2021
Primary Completion
April 30, 2025
Study Completion
April 1, 2026
Last Updated
February 10, 2025
Record last verified: 2024-10