Telegenetics or In-Person Genetic Counselling
ConditionGenetic Counselling
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorNational Cancer Centre, Singapore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.
Other interventionPatients are given a series of questions evaluating cognitive and psychosocial outcomes, either via hardcopy in-person or online internet-facing questionnaire.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 2 weeks after consultationSecondary outcomes
1
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.
Time frame
Up to 2 weeks after consultation2
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.
Time frame
Up to 2 weeks after consultation3
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.
Time frame
Up to 2 weeks after consultationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov