Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
Genetic testing can alter therapy and surgical management for cancer patients and is therefore indicated as a first-line test for many newly diagnosed patients, including breast, ovarian, pancreatic, prostate and colon/GI patients. To reduce pressure on already constrained genetics clinics across Canada, some cancer centres are 'mainstreaming' genetic testing - whereby genetic testing is initiated and mediated by oncologists without traditional pre-test genetic counseling (GC) often using some form of paper-based patient pamphlets or videos. There is no standard, evidence-based approach to mainstreaming, leading to significant practice variation, a lack of coordinated care and ultimately, negative psychological impacts on patients. Digital solutions can address these gaps by providing a standardized, coordinated and patient-centered approach to deliver cancer genetic education. However, digital solutions for providing cancer genetics services are uncommon and clinical-effectiveness and service delivery outcomes have not been well-assessed. This study will test a digital mainstreaming platform called the Genetics Adviser for Mainstream care to assess its effectiveness in improving psychological outcomes and patient-centred care for mainstream cancer patients compared to standard of care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Receiving germline testing related to primary cancer condition initiated by oncologist
18 years old or older.
Speak and read English
Disqualifiers
Receiving cancer genetic testing via a referral to a genetics clinic
Do not speak or read English
Under 18 years of age
Determined to have diminished, marginal and or fluctuating decisional capacity
Trial design
Design model
Parallel
Treatments tested in this trial
Genetics Adviser for Mainstream Care (GA-Mainstream)
BehavioralThe Genetics Adviser for Mainstream Care will educate participants on cancer genetic testing after oncologist-initiated genetic testing. Participants may also receive their results on the GA-Mainstream.
Mainstreaming Standard of Care
BehavioralAfter oncologist-initiated genetic testing, participants may not receive additional information prior to the receipt of their results or they may receive educational materials on cancer genetic testing. Results will be disclosed by either a genetic counselor or oncologist with post-test counseling of select patients.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Intervention arm - GA-Mainstream tool usersExperimental treatment 2 interventions
Group B: Mainstreaming Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Test Specific Distress - Multi-Dimensional Impact of Cancer Risk Assessment (MICRA)
The Multi-Dimensional Impact of Cancer Risk Assessment (MICRA) is a 25-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
Assessed immediately after return of results via intervention (intervention arm only). Assessed at 2-weeks (primary timepoint) and 6 weeks post-return of results for everyone.Secondary outcomes
1
Generalized Distress - Hospital Anxiety & Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a validated tool that assesses symptoms of anxiety and depression in medical and general populations. It consists of 14 items divided into two subscales: Anxiety (HADS-A) and Depression (HADS-D), each with 7 items scored on a 4-point Likert scale with scores ranging from 0-21 per subscale. The measure captures generalized psychological distress by evaluating non-somatic symptoms, making it suitable for use in clinical settings where physical illness may confound mood assessment. Higher scores indicate greater severity of anxiety and depressive symptoms, with established cut-offs for mild, moderate, and severe distress.
Time frame
Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); f) immediately post-return of results via intervention.2
Knowledge - KnowGene
Knowledge will be measured using KnowGene, a measure of knowledge about cancer genetic after cancer genetic counseling and multigene panel testing, an effective and established 16-item questionnaire. Response options include: agree, disagree, or 'don't know'. Either agree or disagree was considered a correct response, depending on the item, with responses being assigned a value of 0 or 1. Higher knowledge scores indicate a higher level of knowledge.
Time frame
Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); f) immediately post-return of results via intervention.3
Empowerment - Genomics Outcome Scale (GOS-6)
Measured by the Genomics Outcome Scale (GOS-6). The Genomics Outcome Scale (GOS) is a 6-item scale that measures empowerment and is a validated short-form of the 24-item Genetic Counselling Outcome Scale (GCOS-24). The 6-item GOS is shorter and more broadly applicable, such as in circumstances where a non-genetics provider has disclosed a result or when results are disclosed online. The GOS includes a 5-point Likert scale from strongly disagree (1 point) to strongly agree (5 points) for a possible score range of 6-30 points on this scale. (PMID: 30496830)
Time frame
Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); and f) immediately post-return of results via intervention.4
Self-Efficacy - Genetic Self Efficacy Scale
Measured by the Genetic Self Efficacy scale. This 5-item scale measures individuals' confidence in their ability to understand the genetic information provided. Participants will be asked to indicate their level of agreement or disagreement (7-point Likert scale from 1 = strongly disagree to 7 = strongly agree). Responses to the items will be summed, with higher scores indicating greater self-efficacy (range: 5-35).
Time frame
Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); and f) immediately post-return of results via intervention.Other outcomes
1
Qualitative interviews with a subset of participants and providers
Interviews with patients will be used to gain further insights into the delivery and support of mainstreaming genetic services with the support of a digital intervention.
Time frame
1-6 months following return of results.2
Health Literacy - BRIEF
Health literacy will be assessed using the BRIEF Health Literacy Screening Tool, a 4-item measure designed to identify an individual's ability to understand and use health information. Each item is quantified using a 5-point scale (1-5) with higher scores indicating higher health literacy.
Time frame
Assessed at baseline.3
Digital Health Literacy - Digital Health Care Literacy Scale
Measured by the Digital Health Care Literacy Scale, a 3-Item measure of digital health literacy. Each item uses a 5-point Likert scale to answer each question with response options ranging from "strongly agree" (4 points) to "strongly disagree" (0 points). The sum of individual items is used to create the total score. Possible scores range from 0 to 12, with higher scores indicating higher digital health care literacy skills.
Time frame
Assessed at baseline.4
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. Collected for both the intervention and control arm.
Time frame
Collected at 2-weeks post-test result disclosure by the clinician.Sponsors and contacts
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Source ClinicalTrials.gov