Cancer Clinical Trial
Official title:
Genetics Adviser: Evaluating a Digital Decision Support Tool for Genetic Results
NCT number | NCT04725565 |
Other study ID # | 3400 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 22, 2021 |
Est. completion date | April 6, 2024 |
Verified date | May 2024 |
Source | Unity Health Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Oncologists are increasingly using genomic sequencing to diagnose and optimize care for their patients. A consequence of this technology is its capacity to detect a patient's risk for thousands of current and future conditions or diseases. Guidelines recommend doctors allow patients to choose which results they wish to receive before ordering the test. It is not feasible to counsel patients on the thousands of possible results because of the limited clinical resources and genomics expertise. Decision aids (DAs) can fill this gap, however there are no DAs to guide patients' decisions about results from genomic sequencing. A DA prototype was developed (GenomicsADvISER.com), the first DA of its kind. This study will transform the DA prototype into an interactive, adaptable and patient-centred digital decision support tool (Genetics ADvISER) via user-centred design methods. The objective of this study is to evaluate the effectiveness of Genetics ADvISER in an RCT with patients being offered results from genomic sequencing. Results of this trial will be used to establish whether the Genetics ADvISER is effective to use in practice. This could fill a critical clinical care gap, improve health outcomes and service use by reducing counselling burden as well as overuse, underuse and misuse - concerns of policy makers seeking to address the triple aims of health care.
Status | Completed |
Enrollment | 133 |
Est. completion date | April 6, 2024 |
Est. primary completion date | April 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Previous control participants from the Incidental Genomics study who have given permission to be re-contacted for related research or a patient who has undergone germline genetic testing (single gene or panel) and received a negative or inconclusive result. - 18 years old or older - Speak and read English. Exclusion Criteria: For participants newly recruited (not part of parent trial CTO# 0819) - Received positive panel testing or panel sequencing - Have not had germline single gene testing related to their primary cancer condition (e.g., BRCA1/2 for breast/ovarian cancer, MLH, MSH, PMS colorectal cancer, etc.) - Received a positive germline genetic test for a cancer gene mutation (e.g., BRCA1/2, MLH, MSH, PMS, APC, MUTYH, etc.) - Currently under cancer treatment - In stage 4, progressive metastatic cancer For all - Do not speak or read English - Under 18 years of age |
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | Princess Margret Cancer Centre | Toronto | Ontario |
Canada | Sunnybrook Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decisional Conflict Scale (DCS) | The Ottawa Decision Support Framework measure of decisional conflict, a 16 item scale - developed by O'Connor et al. Each item is scored 1-5 and a total score on the DCS is calculated by summing all items on the DCS and then dividing by 16, giving a final score between 1 and 5. A lower score on the DCS indicates lower level of decisional conflict. | 1 day | |
Secondary | 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 s indicates a higher level of knowledge. | Assessed at baseline, immediately after baseline/ post intervention, at two weeks, 2 months and 4 months. | |
Secondary | Satisfaction with Decision Scale (SWD) | A six item scale measures a patient satisfaction with a health care decision. Items are scored 1-4. A higher score signifies a higher level of satisfaction or preparation with a decision. Items can be summed and scored (sum the 6 items and divide by 6). | Assessed immediately after baseline/ post intervention, at two weeks, 2 months and 4 months. | |
Secondary | Preparation for Decision Making scale (PrepDM) | A 10 item scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision. Items are scored 1-4. Items can be summed and scored (sum the 10 items and divide by 10). A higher score indicates a higher level of preparation. | Assessed immediately after baseline/ post intervention, at two weeks, 2 months and 4 months. | |
Secondary | State-Trait Anxiety Inventory | Measured using the 20 item State-trait scale. Anxiety was measured using the state subscale of the State-Trait Anxiety Inventory. Items can be summed and scored (sum the 20 items and divide by 20). Higher scores on the State-Trait Anxiety Inventory indicate higher level of anxiety. | Assessed at baseline, immediately after baseline/ post intervention, at two weeks, 2 months and 4 months. | |
Secondary | Hospital Anxiety and Depression Scale (HADS) | 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. | Assessed at baseline, immediately after baseline/post intervention, at two weeks, 2 months and 4 months. | |
Secondary | Acceptability | Assessed using a modified version of the an acceptability questionnaire developed by the Ottawa decision aid framework. Acceptability refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making. Response options to individual items are poor, fair, good excellent, with good and excellent indicating a higher level of acceptability. This is not a scales responses can are reported descriptively for each item separately in terms of proportions responding positively or negatively on each criteria. | Assessed immediately after baseline/ post intervention, at two weeks, 2 months and 4 months. | |
Secondary | Time | Measure of total time with Genetic counselor. | Assessed at immediately after baseline/ post intervention, 2 months and 4 months. |
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