Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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) |
At 5 months, 6 months and 9 months after baseline |
|
| Secondary |
University of North Carolina Genomic Knowledge Scale (UNC-GKS) |
Knowledge is measured using the Genomic Knowledge Scale developed by The University of North Carolina. The scale is an established scale measuring genomics knowledge. Patients mark 25 statements about genes, genetic effects on health, familial inheritance, and diagnostic exome sequencing. Respondents mark each as true, false, or not sure/don't know (scored as incorrect). Correct responses are scored as 1 and summed. Possible scores range from 0-25. Higher scores indicates a higher level of knowledge (PMID: 29928697). |
Assessed at baseline, 2 weeks, 1 month, 5 months, 6 months and 9 months |
|
| Secondary |
SURE |
The SURE screening test 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. |
Assessed at 1 month |
|
| Secondary |
Hospital Anxiety and Depression Scale (HADS) |
Measured using the 14 item scale, each item is answered on a four point (0-3) response category. Possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. Items can be summed and scored for both depression and anxiety, with a score above 11 indicates a case (depression or anxiety). |
Assessed at baseline, 2 weeks, 1 month, 5 months, 6 months and 9 months |
|
| Secondary |
The Genomics Outcome Scale (GOS) |
Patient empowerment is measured using the a shorter version of the Genetic Counselling Outcome Scale (GCOS-24), called Genomics Outcome Scale (GOS). The scale uses 6 patient reported outcome measure items to evaluate genetic counselling and testing services. Each item is scored on a 5-point scale and the final score is calculated by summing all items. Each of the 6 items in the measure is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree) with possible total scores ranging from 6 to 42. A higher score indicates greater empowerment. (PMID: 30496830) |
Assessed at 2 weeks, 1 month, 5 months, 6 months and 9 months |
|
| Secondary |
36-item Short Form Survey (SF-36) |
The SF-36 scale measures quality of life. The SF-36 has 36 items that address physical and mental functioning. Physical and mental health composite scores range from 0 to 100, with 0 indicating the lowest possible level of health, and 100 indicating the highest possible level of health. |
Assessed at baseline, 2 weeks, 1 month, 5 months, 6 months and 9 months |
|
| Secondary |
Satisfaction with Decision Making Scale |
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 at 1 month |
|
| Secondary |
Preparation for Decision Making Scale |
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 at 1 month |
|
| Secondary |
Acceptability e-Scale |
The 6 item Acceptability E-Scale measures acceptability and usability of the platform. The AES includes dimensions of ease of use, understandability of questions, enjoyability of experience, whether the length of time is acceptable, helpfulness, and overall satisfaction, using a 5-point response scale for each item (1=not acceptable, 5=highly acceptable). Scores range from 6 to 30 with a higher score indicating higher acceptability. |
Assessed at 2 weeks, 1 month, 5 months, 6 months and 9 months |
|
| Secondary |
Digital Health Literacy Scale (DHLS) |
Digital Health Literacy Scale (DHLS) is a 3 item scale that measures a respondent's perceived skill at using and applying electronic information technology to health problems. Each item is on a five-point Likert scale ranging from strongly agree to strongly disagree, with responses being assigned a value of 0-4. The scores range from 0-12 with higher scores indicating higher digital health care literacy. |
Control: Assessed at baseline; Intervention: Assessed at baseline |
|
| Secondary |
Frequency of platform use |
Measure of the amount of times the digital platform was accessed by the participant. |
Baseline |
|
| Secondary |
Duration of platform session |
Measure of total time spent using the digital platform. |
2 weeks, 5 months, 6 months and 9 months |
|
| Secondary |
Answers to platform questions |
Measure of value preferences, preference lean and preparation for results. |
Assessed at 2 weeks, 5 months, 6 months and 9 months |
|
| Secondary |
Duration of genetic counselling session |
Measure of total time spent with Genetic counselor in the counselling session. |
Control: immediately after pre-test meeting with clinician, immediately after post-test meeting with clinician; Intervention: immediately after pre-test meeting with clinician, immediately after post-test meeting with clinician |
|
| Secondary |
Qualitative outcomes of counselling sessions |
Patients pre- and post-test clinical encounters will be assessed based off of medical chart notes. |
2 weeks and 6 months |
|
| Secondary |
Qualitative interviews with a subset of participants and providers |
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. The qualitative analyses for the interviews will draw on grounded theory. We will use open coding, constant comparison and axial coding to identify common and divergent themes to characterize the entire dataset. Two researchers will code transcripts independently; consensus on codes will be reached through discussion. Validation methods may include triangulation and member checking. In keeping with qualitative methodology, data analysis will occur in conjunction with data collection. On-going analysis will inform the development of progressive iterations of the interview guides. |
9 months |
|
| Secondary |
BRIEF Health Literacy Screening Tool (BRIEF) |
BREIF is a 4-item scale used to assess health literacy. Each item is quantified using a 5-point scale (1-5) with higher scores indicating higher health literacy. |
Assessed at baseline |
|
| Secondary |
Health Resource Use Questionnaire (RUQ) |
This survey was developed to learn more about the resources related to health, social and community services used to reduce stress of anxiety related to coping with a patient's condition. This is not a scale, each items reports descriptively |
Assessed at 1 month and 9 months |
|
