Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes (MyCancerGene)
Primary Purpose
Cancer, Genetic Predisposition
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyCancerGene
Sponsored by
About this trial
This is an interventional other trial for Cancer
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
Sites / Locations
- Abramson Cancer Center at the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Usual Care Group
Arm Description
Individuals randomized to this arm will receive immediate access to the Interactive Health Communication Application.
Individuals randomized to this arm will receive the standard clinical practice.
Outcomes
Primary Outcome Measures
The KnowGene Scale
Change in Knowledge. Score Range = 0-16. Higher score = Better outcome
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
Secondary Outcome Measures
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
Change in Uncertainty. Score Range = 0-85. Lower score = Better outcome
Impact of Events Scale (IES)
Change in Disease-Specific Distress. Score Range =0-40. Lower score = Better outcome
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
Perceptions of Genetic Disease
Quantitative scales assessing changes in perceived risk, timeline and utility.
Behavioral Risk Factor Surveillance System Questionnaire (BRFSS)
Changes in modifiable cancer lifestyle behaviors. Yes/No responses.
Health and Diet Survey Dietary Guidelines Supplement
Changes in diet and exercise. Yes/No responses.
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
Full Information
NCT ID
NCT04774445
First Posted
February 18, 2021
Last Updated
September 14, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04774445
Brief Title
Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes
Acronym
MyCancerGene
Official Title
Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
American Cancer Society, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Genetic Predisposition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Individuals randomized to this arm will receive immediate access to the Interactive Health Communication Application.
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
Individuals randomized to this arm will receive the standard clinical practice.
Intervention Type
Behavioral
Intervention Name(s)
MyCancerGene
Intervention Description
Interactive Health Communication Application
Primary Outcome Measure Information:
Title
The KnowGene Scale
Description
Change in Knowledge. Score Range = 0-16. Higher score = Better outcome
Time Frame
Baseline - 18 Months
Title
Patient Reported Outcomes Measurement Information System (PROMIS)
Description
Change in General Anxiety and Depression. Score Range = 4-20 for Anxiety/4-20 for Depression. Lower score = Better outcome
Time Frame
Baseline - 18 Months
Secondary Outcome Measure Information:
Title
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
Description
Change in Uncertainty. Score Range = 0-85. Lower score = Better outcome
Time Frame
Baseline - 18 Months
Title
Impact of Events Scale (IES)
Description
Change in Disease-Specific Distress. Score Range =0-40. Lower score = Better outcome
Time Frame
Baseline - 18 months
Title
Test Result Recall
Description
Single item assessing participants' ability to accurately recall their genetic test result. Single answer multiple choice: Positive, Negative, Variant of Uncertain Significance
Time Frame
Baseline - 18 months
Title
Perceptions of Genetic Disease
Description
Quantitative scales assessing changes in perceived risk, timeline and utility.
Time Frame
Baseline - 18 months
Title
Behavioral Risk Factor Surveillance System Questionnaire (BRFSS)
Description
Changes in modifiable cancer lifestyle behaviors. Yes/No responses.
Time Frame
Baseline - 18 months
Title
Health and Diet Survey Dietary Guidelines Supplement
Description
Changes in diet and exercise. Yes/No responses.
Time Frame
Baseline - 18 months
Title
Sharing Genomic Information with Relatives (adapted from the PHENX Toolkit)
Description
Assesses the number of relatives and health care providers patients share genetic test results with
Time Frame
Baseline - 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela R Bradbury, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center at the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes
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