CancerMyCancerGeneNCT04774445
Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes
A study testing MyCancerGene in people with Cancer and Genetic Predisposition, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Genetic Predisposition
- What is being tested?
- MyCancerGene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- •No internet and/or mobile access
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Cancer, Genetic Predisposition
- Being tested
- MyCancerGene
- Medical subject headings
- Neoplasms, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyCancerGeneBehavioural
Interactive Health Communication Application
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Individuals randomized to this arm will receive immediate access to the Interactive Health Communication Application. Receives: Behavioral: MyCancerGene |
| Usual Care Group | No intervention | Individuals randomized to this arm will receive the standard clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The KnowGene Scale
Change in Knowledge. Score Range = 0-16. Higher score = Better outcome
Measured: 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
Measured: Baseline - 18 Months
Secondary outcomes (7)
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
Change in Uncertainty. Score Range = 0-85. Lower score = Better outcome
Measured: Baseline - 18 Months
Impact of Events Scale (IES)
Change in Disease-Specific Distress. Score Range =0-40. Lower score = Better outcome
Measured: Baseline - 18 months
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
Measured: Baseline - 18 months
Perceptions of Genetic Disease
Quantitative scales assessing changes in perceived risk, timeline and utility.
Measured: Baseline - 18 months
Behavioral Risk Factor Surveillance System Questionnaire (BRFSS)
Changes in modifiable cancer lifestyle behaviors. Yes/No responses.
Measured: Baseline - 18 months
Health and Diet Survey Dietary Guidelines Supplement
Changes in diet and exercise. Yes/No responses.
Measured: Baseline - 18 months
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
Measured: Baseline - 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start3 May 2021
- Primary completion30 Apr 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Angela R Bradbury, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774445
- Sponsor's protocol ID
- UPCC 10919
- Other IDs
- 832628
- Acronym
- MyCancerGene
- Status last verified
- Oct 2024
- First submitted
- 18 Feb 2021
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chavez-Yenter D, Fetzer D, Egleston B, Domchek S, Fleisher L, Wagner LI, Wen KY, Karpink K, Gutstein L, Posen S, Selmani E, McLeod B, Anantharajah A, Brown S, Cacioppo C, Cappadocia J, Ebrahimzadeh JE, Falcone D, Howe S, Langer C, McCarthy-Wood B, Weinberg M, Bradbury AR. The MyCancerGene study: a hybrid type 1 effectiveness-implementation randomized study comparing a patient-centered digital genetic health portal to usual care after receipt of cancer genetic testing. BMC Cancer. 2025 Oct 24;25(1):1642. doi: 10.1186/s12885-025-14968-2.
PubMed 41136924
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes
- ClinicalTrials.gov ID
- NCT04774445
- Acronym / sponsor ID
- MyCancerGene / UPCC 10919
- Conditions
- Cancer, Genetic Predisposition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: MyCancerGeneIndividuals randomized to this arm will receive immediate access to the Interactive Health Communication Application. |
| Usual Care Group | No intervention | –Individuals randomized to this arm will receive the standard clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- •No internet and/or mobile access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyCancerGeneInteractive Health Communication Application | Behavioural | Intervention Group |
Primary outcome
The KnowGene Scale
Time frame: Baseline - 18 Months
Change in Knowledge. Score Range = 0-16. Higher score = Better outcome
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: Baseline - 18 Months
Change in General Anxiety and Depression. Score Range = 4-20 for Anxiety/4-20 for Depression. Lower score = Better outcome
7 secondary outcomes
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
Time frame: Baseline - 18 Months
Impact of Events Scale (IES)
Time frame: Baseline - 18 months
Test Result Recall
Time frame: Baseline - 18 months
Perceptions of Genetic Disease
Time frame: Baseline - 18 months
Behavioral Risk Factor Surveillance System Questionnaire (BRFSS)
Time frame: Baseline - 18 months
Health and Diet Survey Dietary Guidelines Supplement
Time frame: Baseline - 18 months
Sharing Genomic Information with Relatives (adapted from the PHENX Toolkit)
Time frame: Baseline - 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 41136924Chavez-Yenter D, Fetzer D, Egleston B, Domchek S, Fleisher L, Wagner LI, Wen KY, Karpink K, Gutstein L, Posen S, Selmani E, McLeod B, Anantharajah A, Brown S, Cacioppo C, Cappadocia J, Ebrahimzadeh JE, Falcone D, Howe S, Langer C, McCarthy-Wood B, Weinberg M, Bradbury AR. The MyCancerGene study: a hybrid type 1 effectiveness-implementation randomized study comparing a patient-centered digital genetic health portal to usual care after receipt of cancer genetic testing. BMC Cancer. 2025 Oct 24;25(1):1642. doi: 10.1186/s12885-025-14968-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela R Bradbury, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyCancerGene in people with Cancer and Genetic Predisposition, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The KnowGene Scale (time frame: Baseline - 18 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04774445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.