The Genetics Update
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
Genomic sequencing (GS) can reveal thousands of genetic variants in each patient. As our understanding of these variants evolves, some may be reclassified, which could have significant implications for a patient's health. However, notifying patients about these changes is challenging and can lead to delays in their care. Patients often feel anxious while waiting for updates, especially when they know their results might change but aren't sure when or how it will affect them. To address this, a new study aims to develop and test a digital platform called "The Genetics Update." This platform will help keep patients informed about their genomic results in a timely manner, potentially reducing the stress and uncertainty that many experience. The study will compare this new approach to the traditional methods of providing updates, such as genetic counseling sessions and letters, to see which is more effective at reducing patient distress. As the use of genomic sequencing continues to grow, finding better ways to communicate updates will become increasingly important.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients who have had germline genome sequencing as part of the Incidental Genomics (CTO #0819), Genetics Adviser (CTO #3400), or GENCOV (CTO #3302) trials and consented to be re-contacted for related research.
Disqualifiers
Individuals who are unable to provide consent to participate in the study will not be eligible.
Patients are unable to participate if they do not speak English or lack access to the internet or an electronic device.
Trial design
Design model
Parallel
Treatments tested in this trial
Genetics Update Platform plus standard genetic counselling
BehavioralPatients in this arm will have continual access to the genetics update platform while they wait for the updated genomic sequencing results. The platform will provide access to relevant educational materials and eventually, results of their genetic tests.
Standard Genetic Counselling
BehavioralStandard Genetic counseling to learn and understand results from genomic sequencing.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Intervention - Genetics Update Platform plus standard genetic counsellingExperimental treatment 1 intervention
Group B: Standard Genetic Counselling OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reduce test-specific distress
The Multi-Dimensional Impact of Cancer Risk Assessment (MICRA) is a 21-item standardized, validated scale that measures the impact of result disclosure from genetic tests. There are three subscales: Distress (6 items), Uncertainty (9 items) and Positive Experiences (4 items). Total scores range from 0-125, with higher scores indicating worse outcome. Scores on the Distress subscale range from 0-30, with higher scores indicating worse outcome. Scores on the Uncertainty subscale range from 0-45, with higher scores indicating worse outcome. Scores on the Positive Experiences Subscale range from 0-20, with higher scores indicating worse outcomes. (PMID: 12433008)
Time frame
At 0, 2 and 4 weeks of receiving genetic test results for both study armsSecondary outcomes
1
Knowledge
Knowledge is measured using a genomics knowledge scale developed by Clinseq, an established 11-item questionnaire consisting of two subscales assessing benefits and limitations of genome sequencing. Responses are on a five-point Likert scale ranging from strongly agree to strongly disagree, with responses being assigned a value of 1-5. Higher knowledge score indicates a higher level of knowledge.
Time frame
Assessed at baseline, after first platform use (for intervention only) and at 0, 2 and 4 weeks of receiving genetic test results for both study arms.2
Decisional Conflict
Decisional conflict is measured by the SURE screening test. It is a 4-item tool to assess decisional conflict in patients, developed by Légaré et al. Each item is scored as a yes (1) or no (0), and a total score is calculated by summing all items. A score less than 4 indicates the probability that a patient experiences clinically significant decisional conflict.
Time frame
Assessed after first platform use for the intervention arm only and at 0, 2 and 4 weeks of receiving genetic test results for both study arms.3
Anxiety and Depression Scale
Assessed using the 14 item Hospital Anxiety and Depression Scale (HADS). HADS has an Anxiety subscale and a Depression subscale, each with 7 questions. Add the scores of each of the 7 questions of the Anxiety subscale for a total score on the Anxiety subscale. Add the scores of each of the 7 questions of the Depression subscale for a total score on the Depression subscale. Scores range, 0-21 on each subscale; score \> 10 indicates clinical anxiety or depression; scores 8-10 indicate "borderline" anxiety or depression.
Time frame
Assessed at baseline, after first platform use (for intervention only) and at 0, 2 and 4 weeks of receiving genetic test results for both study arms.4
Quality of Life (SF-12)
Physical and mental health measured using the 12-item short-form health survey (SF-12) scales.
Time frame
Assessed at baseline, after first platform use (for intervention only) and at 0, 2 and 4 weeks of receiving genetic test results for both study arms.Other outcomes
1
Clinician time preparing for the session, counseling and post-session
Measure of total time spent preparing for the genetic counselling session, time with the Genetic Counselor in the counselling session and time spent preparing letters and chart notes after the session.
Time frame
Collected at 2-weeks post-test result disclosure by the clinician for both study arms.2
Duration of platform session
Measure of total time spent using the digital platform.
Time frame
Assessed after first platform use and at 0, 2 and 4 weeks of receiving genetic test results for intervention arm only.3
Frequency of platform use
Measure of the number of times the digital platform was accessed by the participant using
Time frame
Assessed after first platform use and at 0, 2 and 4 weeks of receiving genetic test results for intervention arm only.4
Qualitative interviews with a subset of participants
We will use in-depth interviews with patients to provide further insights into the delivery and support of genetic services. Interviews will consider participants' socio-demographic factors that may influence their informational, decisional, and follow-up needs as well as how they engage with genetic information, participate in shared decision making, and manage genetic test results.
Time frame
Within 6 months of completing the studySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: