Clinical trial NCT04738708: Telegenetics or In-Person Genetic Counselling
Official title: Telegenetics or In-Person Genetic Counselling: A Comparison of Clinical Outcomes and Cost
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genetic Counselling
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Genomics Outcome Scale
timeFrame: Up to 2 weeks after consultation
Secondary outcomes:
measure: Adapted Multidimensional Measure of Informed Choice (MMIC) for Hereditary Breast and Ovarian Cancer (HBOC) and Lynch
timeFrame: Up to 2 weeks after consultation
measure: Genetic Counselling Satisfaction Scale
timeFrame: Up to 2 weeks after consultation
measure: Telehealth Patient Survey
timeFrame: Up to 2 weeks after consultation
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Ryan Tan
role: PRINCIPAL_INVESTIGATOR
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