Scalable Communication Modalities for Returning Genetic Research Results

Scalable Communication Modalities for Returning Genetic Research Results

Number of participant that decide to learn genetic results at 6 weeks [ Time Frame: 6 weeks ]
Decisions about learning genetic results for hereditary breast and ovarian cancer will be monitored and recorded in the electronic study database system.

Number of participant that decide to learn genetic results at 6 months [ Time Frame: 6 months ]
Decisions about learning genetic results for hereditary breast and ovarian cancer will be monitored and recorded in the electronic study database system.

Change from baseline in breast cancer genetics knowledge based on questionnaire at responses at 6 weeks [ Time Frame: Baseline, 6 weeks ]
Knowledge about breast cancer genetics will be assessed using an investigator derived questionnaire consisting of 16 items. Higher scores out of ten are associated with more genetics knowledge.

Change in baseline depression at 6 weeks [ Time Frame: Baseline, 6 weeks ]
Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.

Depression at 6 months [ Time Frame: 6 months ]
Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.

Depression at 12 months [ Time Frame: 12 months ]
Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.

Change in baseline anxiety at 6 weeks [ Time Frame: Baseline, 6 weeks ]
Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.

Anxiety at 6 months [ Time Frame: 6 months ]
Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.

Anxiety at 12 months [ Time Frame: 12 months ]
Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.

Participant distress from cancer risk assessment (test-specific distress) at 6 weeks [ Time Frame: 6 weeks ]
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.

Participant distress from cancer risk assessment (test-specific distress) at 6 months [ Time Frame: 6 months ]
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.

Participant distress from cancer risk assessment (test-specific distress) at 12 months [ Time Frame: 12 months ]
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.

Participant uncertainty from cancer risk assessment at 6 weeks [ Time Frame: 6 weeks ]
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.

Participant uncertainty from cancer risk assessment at 6 months [ Time Frame: 6 months ]
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.

Participant uncertainty from cancer risk assessment at 12 months [ Time Frame: 12 months ]
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.

Source: View full study details on ClinicalTrials.gov

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March 30, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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