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NCT Number: NCT04738708

Telegenetics or In-Person Genetic Counselling

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.

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Centre Singapore

Singapore, 169610

Location status: Recruiting

Location contact

Ryan Tan

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Patients are given a series of questions evaluating cognitive and psychosocial outcomes, either via hardcopy in-person or online internet-facing questionnaire.

Primary outcomes

  1. Genomics Outcome Scale

    Time frame: 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 outcomes

  1. Adapted Multidimensional Measure of Informed Choice (MMIC) for Hereditary Breast and Ovarian Cancer (HBOC) and Lynch

    Time frame: 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.

  2. Genetic Counselling Satisfaction Scale

    Time frame: 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.

  3. Telehealth Patient Survey

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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