Telegenetics or In-Person Genetic Counselling

Study Overview
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Brief Summary
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This study aims to compare clinical outcomes (informed choice and genetic counselling outcomes) and cost (provider and patient time, travel, and telehealth platform) between telegenetics and in-person genetic counselling.

Detailed Description
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This study will compare the patient-reported outcomes of telegenetics with in-person consultations for participants considering germline testing for HBOC or Lynch syndrome. It will clarify if telegenetics is a feasible and non-inferior alternative to in-person cancer genetic counselling. Participant responses are important stakeholder views to guide the design of telegenetics to become a mainstream service delivery model welcomed by patients. It aims to recruit 150 prospective consecutive patients attending genetic counselling for Hereditary Breast and Ovarian Cancer (HBOC) and Lynch Syndrome in Clinical Genetic Services (CGS) at National Cancer Centre Singapore (NCCS). Upon completion of the genetic consultation appointments, patients will be completing a series of questions evaluating cognitive and psychosocial outcomes either via hardcopy in-person or online internet-facing questionnaire.

Official Title
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Telegenetics or In-Person Genetic Counselling: A Comparison of Clinical Outcomes and Cost

Conditions
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Genetic Counselling

Intervention / Treatment
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* Other: Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 21 years old. Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling. Able to read and understand the English Language. Able to consent and agree to be randomized to either telegenetics or in-person genetic counselling. Exclusion Criteria: Under the age of 21 years old. Patients who require genetic results urgently. Cognitive difficulty/ impairment or current psychiatric or physical illness (visual/ hearing/ neurological) which impairs sound judgement and accurate reporting of medical history over video consultation.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.<br>Patients attending genetic counselling for Hereditary Breast and Ovarian Cancer (HBOC) and Lynch Syndrome in Clinical Genetic Services (CGS) at National Cancer Centre Singapore (NCCS) | Other: Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.<br>* Patients are given a series of questions evaluating cognitive and psychosocial outcomes, either via hardcopy in-person or online internet-facing questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genomics Outcome Scale | Patient reported outcomes will be compared with a 6 item Genomics Outcome Scale (GOS) across five domains (decisional control, cognitive control, behavioral control, emotional regulation and hope) which are rated on a 5-point Likert scale ranging from strongly agree to strongly disagree. Scores are summed to provide an overall empowerment where higher scores equal higher levels of empowerment. | Up to 2 weeks after consultation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adapted Multidimensional Measure of Informed Choice (MMIC) for Hereditary Breast and Ovarian Cancer (HBOC) and Lynch | Participant's knowledge and attitude of HBOC and Lynch syndrome will be compared with a multi-dimensional measure of informed choice (MMIC) which composed of 11 items for knowledge of HBOC or 12 items for knowledge of Lynch syndrome and 4 items for attitudes. Items will be summed with a score or rated on a 7-pointed Likert scale. | Up to 2 weeks after consultation | 
| Genetic Counselling Satisfaction Scale | Genetic counselling satisfaction is measured with a 6 item Genetic Counselling Satisfaction Scale. Items will be rated on a 5-point Likert scale and summed. Higher scores indicating higher satisfaction. | Up to 2 weeks after consultation | 
| Telehealth Patient Survey | Telehealth satisfaction is measured with a 7 item Telehealth Patient Survey. Items will be rated on a 5-point Likert scale and summed. Higher scores indicating higher satisfaction. | Up to 2 weeks after consultation |