Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes

Cancer Clinical Trial

— MyCancerGene  

Official title:

Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04369196
• Other study ID #: UPCC-10919
• Secondary ID: 832628
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2020
• Est. completion date: May 2025

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: Angela R Bradbury, MD
• Phone: 215 615 3341
• Email: Angela.Bradbury[@]uphs.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. We 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.

Description:

As we increasingly use multi-gene testing in clinical practice, 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 we need 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 study will provide patients access using an Interactive Health Communication Application, MyCancerGene, to information about their genetic testing, their specific results and the implications, ability to print reports and other materials for their relatives and other health care providers and periodic reminders for cancer screening 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. We 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 help us understand who benefits most and least from this intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: May 2025
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 30 days prior to recruitment)

Exclusion Criteria:

• No internet and/or mobile access

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• MyCancerGene
Interactive Health Communication Application

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	American Cancer Society, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Understanding of Genetic Information	Knowledge of genetic disease will be evaluated using an adapted version of the Cancer Genetics Knowledge scale.	Baseline, 1, 6, 12, 18 and 24 months post randomization
Primary	Changes in Understanding of Genetic Information	Knowledge of genetic disease will be evaluated using a version of the ClinSeq knowledge scale.	Baseline, 1, 6, 12, 18 and 24 months post randomization
Primary	General Anxiety Changes	Assess anxiety with the Hospital Anxiety and Depression Scale (HADS) subscales	Baseline, 1, 6, 12, 18 and 24 months post randomization
Secondary	Test Result Recall	Recall of genetic test results.	1, 6, 12, 18 and 24 months post randomization
Secondary	Depression Scale changes	Assessed with the Hospital Anxiety and Depression Scale (HADS) subscales	Baseline, 1, 6, 12, 18 and 24 months post randomization
Secondary	Uncertainty changes	Assessed using a 3-item scale adapted from the uncertainty subscale of the Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA).	Baseline, 1, 6, 12, 18 and 24 months post randomization
Secondary	Cancer-Specific Distress Changes	Measured using the Revised Impact of Events Scale (RIES)	Baseline, 1, 6, 12, 18 and 24 months post randomization
Secondary	Communication to relatives and health care providers	Includes both intention to communicate and reported communication with 4 items utilized in COGENT.	Baseline, 1, 6, 12, 18 and 24 months post randomization
Secondary	Performance of risk reduction and screening behaviors	Assessed with 13 self-report items utilized in COGENT to assess risk reducing and screening recommendations after multi-gene testing	Baseline, 1, 6, 12, 18 and 24 months post randomization