<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03244202</url>
  </required_header>
  <id_info>
    <org_study_id>16-052</org_study_id>
    <nct_id>NCT03244202</nct_id>
  </id_info>
  <brief_title>Evaluation of a Decision Aid for Incidental Genomic Findings</brief_title>
  <official_title>Randomized Controlled Trial of a Decision Aid for Incidental Genomic Findings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Health care providers (HCP) are increasingly using genomic sequencing (GS) to target&#xD;
      treatment for patients. However, GS may incidentally reveal inherited risks for thousands of&#xD;
      current and future diseases. Guidelines recommend HCP inform patients of incidental GS&#xD;
      results. No decision aid (DA) exists to guide patients' decisions about which incidental GS&#xD;
      results they wish to learn. This study will evaluate whether the DA followed by genetic&#xD;
      counselling (GC) reduces decisional conflict compared to GC alone in a randomized controlled&#xD;
      trial (RCT) with 128 patients with a family history of cancer, who have had a negative&#xD;
      genetic test and may eligible for GS. A qualitative component with a subset of participants&#xD;
      (n=40) will explore patients' preferences for the types of incidental results they wish to&#xD;
      receive and their decision making process.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: Health care providers are increasingly using GS to diagnose, prognose and treat&#xD;
      diseases. GS offers increased sensitivity over classic genetic tests, decreasing&#xD;
      time-consuming and costly diagnostic cascades. However, GS may also incidentally reveal&#xD;
      inherited risks for many other cancers and diseases. Guidelines recommend doctors inform&#xD;
      patients of their incidental GS results. Yet there are limited tools to communicate the scope&#xD;
      and implications of the thousands incidental results available to help guide patients'&#xD;
      decisions about which results they wish to learn.&#xD;
&#xD;
      Gaps: Decision aids (DAs) are best suited to meet this challenge, but no DA exists to guide&#xD;
      patients' decisions about incidental GS results.&#xD;
&#xD;
      Rationale: It is not feasible to counsel patients on the thousands of incidental findings&#xD;
      available to make informed choices about which incidental results they wish to receive&#xD;
      because of the limited genomics expertise and capacity among oncologists, and the long wait&#xD;
      times for genetic counseling. Our DA fills this critical care and translational gap by&#xD;
      improving the quality of patients' decisions and saving oncologists time counseling patients&#xD;
      on incidental findings.&#xD;
&#xD;
      Preliminary data: 1) DA development: We created an interactive online DA. It begins with a&#xD;
      professional whiteboard video (by Dr. Mike Evans) that conveys the key concepts, risks and&#xD;
      benefits of learning about incidental GS results to educate patients. It then prepares&#xD;
      patients for decision-making using a values clarification exercise (with feedback of their&#xD;
      preferences) and a knowledge questionnaire (with correct answers provided after). It ends by&#xD;
      asking participants to select result categories they want to learn using a menu tool. 2)&#xD;
      Usability testing: We also evaluated the DA's usability with 15 patients in 2 rounds.&#xD;
      Interviews demonstrated strong face validity and content comprehension. Most patients found&#xD;
      the amount of information 'just right' (11/15), clear (12/15) and balanced (14/15). All&#xD;
      patients felt that the information was sufficient to reach a decision, that the DA was easy&#xD;
      to use and would recommend it.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
        1. Evaluate the efficacy of the DA compared to standard genetic counseling (GC)&#xD;
&#xD;
        2. Understand the decision-making patients' use regarding GS and selecting incidental&#xD;
           findings.&#xD;
&#xD;
      METHODS&#xD;
&#xD;
      Phase 1 - RCT to evaluate the DA:&#xD;
&#xD;
      Methods: We will evaluate the efficacy of the DA in reducing decisional conflict compared to&#xD;
      standard genetic counseling (GC) using a superiority trial.&#xD;
&#xD;
      Population: We will recruit adult cancer patients who are eligible to have GS (i.e., tested&#xD;
      negative for the classic gene mutation associated with their cancer - e.g., BRCA1/2, MLH,&#xD;
      MSH, PMS, APC, MUTYH) from genetics clinics at Mount Sinai Hospital, Princess Margaret&#xD;
      Hospital and Sunnybrook Hospital in Toronto, ON Canada. We will include adults who speak and&#xD;
      read English and exclude patients with metastatic/recurrent disease as incidental results are&#xD;
      less consequential to this population.&#xD;
&#xD;
      Sample size: TThe primary outcome is decisional conflict; the study requires 64 patients/arm&#xD;
      to detect the minimal clinically important difference (MCID) of 0.3 using the Decisional&#xD;
      Conflict Scale (DCS) (Appendix 3), assuming a standard deviation of 0.6, an alpha of 0.05&#xD;
      (two-sided) and power of 0.815,16. In the last 3 months, 244 patients with a family history&#xD;
      of breast and colon cancer tested negative for their associated classic mutations (BRCA1/2,&#xD;
      MLH, MSH, PMS, APC, MUTYH) most of who would be eligible for GS. Extrapolating this over the&#xD;
      next 9 months we estimate that there would be 732 eligible patients. It is highly feasible to&#xD;
      reach our target of 128 patients.&#xD;
&#xD;
      Participants will be consecutively randomized and allocated from an existing list of eligible&#xD;
      subjects using a computer-generated randomization in a 1:1 ratio with random permuted blocks&#xD;
      of varying sizes. Patients from each clinic will be randomized separately to ensure we have&#xD;
      an even distribution of this population in both arms of the study.&#xD;
&#xD;
      Intervention arm: Participants will view the online DA and then complete the online&#xD;
      self-administered measures (below) in one sitting within 14 days of recruitment. Next, they&#xD;
      will speak with a GC over the telephone after the DA, using a standardized script. They will&#xD;
      then complete the same online measures again after speaking to the GC.&#xD;
&#xD;
      Control arm: The GC will conduct the GC session over the telephone within 14 days of&#xD;
      recruitment. A topics script will be used to standardize GC discussions covering standard&#xD;
      educational content to enable patients to select incidental GS results (participants will not&#xD;
      view the DA nor the video). Participants will complete the online self-administered measures&#xD;
      after speaking with the GC.&#xD;
&#xD;
      Outcome: Consistent with the Ottawa Decisional Support Framework, our primary outcome is&#xD;
      decisional conflict. Secondary outcomes are: knowledge of GS, satisfaction with decision,&#xD;
      preparation for decision-making and anxiety.&#xD;
&#xD;
      Measures: We will use validated scales to assess decisional conflict, knowledge, anxiety,&#xD;
      satisfaction with the decision and preparation for decision-making. We will develop a&#xD;
      standardized topic script for the GC in each arm, as well as a questionnaire to collect&#xD;
      intervention fidelity (e.g., usage statistics, duration of counseling sessions), demographic&#xD;
      and clinical characteristics (e.g., cancer status and genetic testing).&#xD;
&#xD;
      Analysis: Consistent with the Ottawa Decision Support Framework, our primary outcome is&#xD;
      decisional conflict, assessed via the validated Decisional Conflict Scale (DCS). Knowledge is&#xD;
      the secondary outcome, will be measured by the Cliseq genomic sequencing questionnaire and a&#xD;
      set of internal developed knowledge questions. Satisfaction and anxiety with also be&#xD;
      assessed. Satisfaction will be measured using the Satisfaction with Decision scale (SWD) and&#xD;
      the Preparation for Decision Making scale (PrepDM). Anxiety will be measured using the state&#xD;
      subscale of the State-Trait Anxiety Inventory (STAI). We will also include a demographics and&#xD;
      cancer history questionnaire.&#xD;
&#xD;
      The analysis of outcomes will follow the intention-to-treat (ITT) approach. Mean DCS, SWD,&#xD;
      PrepDM and STAI scores will be compared using a t-test. Knowledge scores will be assessed by&#xD;
      summing the number of correct responses to the questions, and compared using t-tests. Linear&#xD;
      regression will be used in a secondary analysis to account for known predictors for&#xD;
      decisional outcomes such as education. Secondary analyses will compare the mean DCS,&#xD;
      knowledge, SWD, PrepDM and STAI scores before and after GC in the intervention arm to explore&#xD;
      the additional benefit of GC after the DA. Un/adjusted mean differences and 95% confidence&#xD;
      intervals will be reported. We will use descriptive statistics to report participants'&#xD;
      characteristics.&#xD;
&#xD;
      Phase 2 - qualitative study of decision making for incidental results:&#xD;
&#xD;
      A subset of study participants will be asked to take part in a qualitative interview about&#xD;
      their decision-making regarding selecting incidental findings. These semi-structured&#xD;
      interviews will take place over the phone with a total of 40 participants. For the&#xD;
      qualitative component a purposeful sample of study participants will be used. We will target&#xD;
      a mix of participants across ages, cancer type and stage, gender, and study group to assess&#xD;
      the varying approaches to decision-making. At total of 40 participants will take part in the&#xD;
      qualitative component.&#xD;
&#xD;
      Analysis: Qualitative data analysis will draw on grounded theory methodology. We will sort&#xD;
      the data by searching for themes/patterns and variations within and across interviews using&#xD;
      HypeRESEARCH. Coding, which is the first stage in the analysis process, will involve&#xD;
      'labeling' the data with descriptive codes. Two team members will independently code each&#xD;
      transcript. Consensus on coding will be reached through comparison and discussion among these&#xD;
      members. The second stage will involve constant comparison, where codes and their content&#xD;
      will be compared across interviews to discern common and divergent themes and issues across&#xD;
      them. The final stage is selective coding, which integrates all the codes under a central&#xD;
      phenomenon to build a theory. Validation methods include triangulation and member checking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2016</start_date>
  <completion_date type="Actual">April 2, 2018</completion_date>
  <primary_completion_date type="Actual">April 2, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decisional Conflict</measure>
    <time_frame>Immediately after intervention</time_frame>
    <description>The Ottawa Decision Support Framework measure of decisional conflict, a 16 item scale - developed by O'Connor et al.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge</measure>
    <time_frame>Measured at baseline (before intervention) and immediately after intervention.</time_frame>
    <description>Knowledge is measured using a genomics knowledge scale developed by Clinseq</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preparation for decision making</measure>
    <time_frame>Immediately after intervention</time_frame>
    <description>A 10 item scale measuring how useful a user finds the decision aid or other intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with decision</measure>
    <time_frame>Immediately after intervention</time_frame>
    <description>A six item scale measures a patient satisfaction with a health care decision</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Measured at baseline (before intervention) and immediately after intervention.</time_frame>
    <description>Mesured using the 20 item State-trait scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Decision Aid Plus Counselling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will use a decision aid to learn about genomic sequencing and select which incidental findings they would like to receive from genomic sequencing. After using the decision aid the participants will speak with a genetic counsellor over the phone about their choice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Genetic Counselling Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will a genetic counsellor over the phone to learn about genomic sequencing and select which incidental findings they would like to receive from genomic sequencing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision Aid Plus Counselling</intervention_name>
    <description>The Genomics ADViSER is an decision aid designed to inform patients about genomic sequencing (GS) and aid them selecting which incidental findings they would like to receive from GS.</description>
    <arm_group_label>Decision Aid Plus Counselling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genetic Counselling Only</intervention_name>
    <description>Participants will learn about genomic sequencing and incidental findings by speaking directly with a genetic counsellor and select which incidental findings they would like to receive with a genetic counsellor.</description>
    <arm_group_label>Genetic Counselling Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a family history of cancer&#xD;
&#xD;
          -  Received a negative single gene test for a cancer gene mutation (e.g., BRCA1/2, MLH,&#xD;
             MSH, PMS, etc.) or received a negative panel test&#xD;
&#xD;
          -  Speak and read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are in advanced stage cancer (stage 5)&#xD;
&#xD;
          -  Received positive panel testing or panel sequencing&#xD;
&#xD;
          -  Have not had single gene testing related to their primary cancer condition (e.g.,&#xD;
             BRCA1/2 for breast/ovarian cancer, MLH, MSH, PMS colorectal cancer, etc.)&#xD;
&#xD;
          -  Received a positive genetic test for a cancer gene mutation (e.g., BRCA1/2, MLH, MSH,&#xD;
             PMS, APC, MUTYH, etc.)&#xD;
&#xD;
          -  Do not speak or read English&#xD;
&#xD;
          -  Family member participating in the study&#xD;
&#xD;
          -  Participant in usability study of the DA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yvonne Bombard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Michael's Hospital and University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Incidental Findings</keyword>
  <keyword>Decision Aids</keyword>
  <keyword>Genomic Sequencing</keyword>
  <keyword>Randomized Controlled Trail</keyword>
  <keyword>Genetic Counselling</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 6, 2020</submitted>
    <returned>May 22, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03244202
org study id: 16-052
nct id: NCT03244202
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Health care providers (HCP) are increasingly using genomic sequencing (GS) to target
      treatment for patients. However, GS may incidentally reveal inherited risks for thousands of
      current and future diseases. Guidelines recommend HCP inform patients of incidental GS
      results. No decision aid (DA) exists to guide patients' decisions about which incidental GS
      results they wish to learn. This study will evaluate whether the DA followed by genetic
      counselling (GC) reduces decisional conflict compared to GC alone in a randomized controlled
      trial (RCT) with 128 patients with a family history of cancer, who have had a negative
      genetic test and may eligible for GS. A qualitative component with a subset of participants
      (n=40) will explore patients' preferences for the types of incidental results they wish to
      receive and their decision making process.
BACKGROUND: Health care providers are increasingly using GS to diagnose, prognose and treat
      diseases. GS offers increased sensitivity over classic genetic tests, decreasing
      time-consuming and costly diagnostic cascades. However, GS may also incidentally reveal
      inherited risks for many other cancers and diseases. Guidelines recommend doctors inform
      patients of their incidental GS results. Yet there are limited tools to communicate the scope
      and implications of the thousands incidental results available to help guide patients'
      decisions about which results they wish to learn.

      Gaps: Decision aids (DAs) are best suited to meet this challenge, but no DA exists to guide
      patients' decisions about incidental GS results.

      Rationale: It is not feasible to counsel patients on the thousands of incidental findings
      available to make informed choices about which incidental results they wish to receive
      because of the limited genomics expertise and capacity among oncologists, and the long wait
      times for genetic counseling. Our DA fills this critical care and translational gap by
      improving the quality of patients' decisions and saving oncologists time counseling patients
      on incidental findings.

      Preliminary data: 1) DA development: We created an interactive online DA. It begins with a
      professional whiteboard video (by Dr. Mike Evans) that conveys the key concepts, risks and
      benefits of learning about incidental GS results to educate patients. It then prepares
      patients for decision-making using a values clarification exercise (with feedback of their
      preferences) and a knowledge questionnaire (with correct answers provided after). It ends by
      asking participants to select result categories they want to learn using a menu tool. 2)
      Usability testing: We also evaluated the DA's usability with 15 patients in 2 rounds.
      Interviews demonstrated strong face validity and content comprehension. Most patients found
      the amount of information 'just right' (11/15), clear (12/15) and balanced (14/15). All
      patients felt that the information was sufficient to reach a decision, that the DA was easy
      to use and would recommend it.

      OBJECTIVES

        1. Evaluate the efficacy of the DA compared to standard genetic counseling (GC)

        2. Understand the decision-making patients' use regarding GS and selecting incidental
           findings.

      METHODS

      Phase 1 - RCT to evaluate the DA:

      Methods: We will evaluate the efficacy of the DA in reducing decisional conflict compared to
      standard genetic counseling (GC) using a superiority trial.

      Population: We will recruit adult cancer patients who are eligible to have GS (i.e., tested
      negative for the classic gene mutation associated with their cancer - e.g., BRCA1/2, MLH,
      MSH, PMS, APC, MUTYH) from genetics clinics at Mount Sinai Hospital, Princess Margaret
      Hospital and Sunnybrook Hospital in Toronto, ON Canada. We will include adults who speak and
      read English and exclude patients with metastatic/recurrent disease as incidental results are
      less consequential to this population.

      Sample size: TThe primary outcome is decisional conflict; the study requires 64 patients/arm
      to detect the minimal clinically important difference (MCID) of 0.3 using the Decisional
      Conflict Scale (DCS) (Appendix 3), assuming a standard deviation of 0.6, an alpha of 0.05
      (two-sided) and power of 0.815,16. In the last 3 months, 244 patients with a family history
      of breast and colon cancer tested negative for their associated classic mutations (BRCA1/2,
      MLH, MSH, PMS, APC, MUTYH) most of who would be eligible for GS. Extrapolating this over the
      next 9 months we estimate that there would be 732 eligible patients. It is highly feasible to
      reach our target of 128 patients.

      Participants will be consecutively randomized and allocated from an existing list of eligible
      subjects using a computer-generated randomization in a 1:1 ratio with random permuted blocks
      of varying sizes. Patients from each clinic will be randomized separately to ensure we have
      an even distribution of this population in both arms of the study.

      Intervention arm: Participants will view the online DA and then complete the online
      self-administered measures (below) in one sitting within 14 days of recruitment. Next, they
      will speak with a GC over the telephone after the DA, using a standardized script. They will
      then complete the same online measures again after speaking to the GC.

      Control arm: The GC will conduct the GC session over the telephone within 14 days of
      recruitment. A topics script will be used to standardize GC discussions covering standard
      educational content to enable patients to select incidental GS results (participants will not
      view the DA nor the video). Participants will complete the online self-administered measures
      after speaking with the GC.

      Outcome: Consistent with the Ottawa Decisional Support Framework, our primary outcome is
      decisional conflict. Secondary outcomes are: knowledge of GS, satisfaction with decision,
      preparation for decision-making and anxiety.

      Measures: We will use validated scales to assess decisional conflict, knowledge, anxiety,
      satisfaction with the decision and preparation for decision-making. We will develop a
      standardized topic script for the GC in each arm, as well as a questionnaire to collect
      intervention fidelity (e.g., usage statistics, duration of counseling sessions), demographic
      and clinical characteristics (e.g., cancer status and genetic testing).

      Analysis: Consistent with the Ottawa Decision Support Framework, our primary outcome is
      decisional conflict, assessed via the validated Decisional Conflict Scale (DCS). Knowledge is
      the secondary outcome, will be measured by the Cliseq genomic sequencing questionnaire and a
      set of internal developed knowledge questions. Satisfaction and anxiety with also be
      assessed. Satisfaction will be measured using the Satisfaction with Decision scale (SWD) and
      the Preparation for Decision Making scale (PrepDM). Anxiety will be measured using the state
      subscale of the State-Trait Anxiety Inventory (STAI). We will also include a demographics and
      cancer history questionnaire.

      The analysis of outcomes will follow the intention-to-treat (ITT) approach. Mean DCS, SWD,
      PrepDM and STAI scores will be compared using a t-test. Knowledge scores will be assessed by
      summing the number of correct responses to the questions, and compared using t-tests. Linear
      regression will be used in a secondary analysis to account for known predictors for
      decisional outcomes such as education. Secondary analyses will compare the mean DCS,
      knowledge, SWD, PrepDM and STAI scores before and after GC in the intervention arm to explore
      the additional benefit of GC after the DA. Un/adjusted mean differences and 95% confidence
      intervals will be reported. We will use descriptive statistics to report participants'
      characteristics.

      Phase 2 - qualitative study of decision making for incidental results:

      A subset of study participants will be asked to take part in a qualitative interview about
      their decision-making regarding selecting incidental findings. These semi-structured
      interviews will take place over the phone with a total of 40 participants. For the
      qualitative component a purposeful sample of study participants will be used. We will target
      a mix of participants across ages, cancer type and stage, gender, and study group to assess
      the varying approaches to decision-making. At total of 40 participants will take part in the
      qualitative component.

      Analysis: Qualitative data analysis will draw on grounded theory methodology. We will sort
      the data by searching for themes/patterns and variations within and across interviews using
      HypeRESEARCH. Coding, which is the first stage in the analysis process, will involve
      'labeling' the data with descriptive codes. Two team members will independently code each
      transcript. Consensus on coding will be reached through comparison and discussion among these
      members. The second stage will involve constant comparison, where codes and their content
      will be compared across interviews to discern common and divergent themes and issues across
      them. The final stage is selective coding, which integrates all the codes under a central
      phenomenon to build a theory. Validation methods include triangulation and member checking.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Decisional Conflict
time frame: Immediately after intervention
description: The Ottawa Decision Support Framework measure of decisional conflict, a 16 item scale - developed by O'Connor et al.
measure: Knowledge
time frame: Measured at baseline (before intervention) and immediately after intervention.
description: Knowledge is measured using a genomics knowledge scale developed by Clinseq
measure: Preparation for decision making
time frame: Immediately after intervention
description: A 10 item scale measuring how useful a user finds the decision aid or other intervention
measure: Satisfaction with decision
time frame: Immediately after intervention
description: A six item scale measures a patient satisfaction with a health care decision
measure: Anxiety
time frame: Measured at baseline (before intervention) and immediately after intervention.
description: Mesured using the 20 item State-trait scale
arm group label: Decision Aid Plus Counselling
arm group type: Experimental
description: Participants will use a decision aid to learn about genomic sequencing and select which incidental findings they would like to receive from genomic sequencing. After using the decision aid the participants will speak with a genetic counsellor over the phone about their choice.
arm group label: Genetic Counselling Only
arm group type: Active Comparator
description: Participants will a genetic counsellor over the phone to learn about genomic sequencing and select which incidental findings they would like to receive from genomic sequencing.
intervention type: Other
intervention name: Decision Aid Plus Counselling
description: The Genomics ADViSER is an decision aid designed to inform patients about genomic sequencing (GS) and aid them selecting which incidental findings they would like to receive from GS.
arm group label: Decision Aid Plus Counselling
intervention type: Other
intervention name: Genetic Counselling Only
description: Participants will learn about genomic sequencing and incidental findings by speaking directly with a genetic counsellor and select which incidental findings they would like to receive with a genetic counsellor.
arm group label: Genetic Counselling Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yvonne Bombard, PhD
role: Principal Investigator
affiliation: St. Michael's Hospital and University of Toronto
facility: 
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No
submitted: May 6, 2020
returned: May 22, 2020