Telegenetics or In-Person Genetic Counselling

Recruiting

• Conditions: Genetic Counselling
• Interventions: Other: Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.

• Registration Number: NCT04738708
• Lead Sponsor: National Cancer Centre, Singapore

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.

Study Timeline

• Study First Submitted: 2021-01-31
• Study First Submitted QC: 2021-01-31
• Study Start: 2021-02-01
• Study First Posted: 2021-02-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-10-16
• Study Completion: 2025-10-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.	Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.	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)

Primary Outcome Measures

Name	Time	Method
Genomics Outcome Scale	Up to 2 weeks after consultation	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.

Secondary Outcome Measures

Name	Time	Method
Telehealth Patient Survey	Up to 2 weeks after consultation	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.
Adapted Multidimensional Measure of Informed Choice (MMIC) for Hereditary Breast and Ovarian Cancer (HBOC) and Lynch	Up to 2 weeks after consultation	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.
Genetic Counselling Satisfaction Scale	Up to 2 weeks after consultation	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.

Trial Locations

Locations (1)

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore