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Genetic CounsellingNCT04738708

Telegenetics or In-Person Genetic Counselling

An observational study of Genetic Counselling, run by National Cancer Centre, Singapore at 1 site in Singapore.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Genetic Counselling
What is being tested?
Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.
How many people
150 participants
Where
1 siteSingapore
Study dates
1 Feb 2021to 6 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Singapore1 site, 1 recruiting
  • National Cancer Centre Singapore

    Singapore, 169610

    Ryan Tan

    Recruiting

Other trials in Singapore

About this study

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

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.

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04738708
Study groupRoleWhat they receive
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)
Receives: Other: Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 2 weeks after consultation

Secondary outcomes (3)
  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.

    Measured: Up to 2 weeks after consultation

  2. 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.

    Measured: Up to 2 weeks after consultation

  3. 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.

    Measured: Up to 2 weeks after consultation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start1 Feb 2021
  3. Primary completion6 Oct 2026 (estimated)
  4. Study completion6 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04738708
Sponsor's protocol ID
002.1
Status last verified
Apr 2026
First submitted
31 Jan 2021
Last updated
28 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lee AKF, Cho RHW, Lau EHL, Cheng HK, Wong EWY, Ku PKM, Chan JYK, Yeung ZWC. Mitigation of head and neck cancer service disruption during COVID-19 in Hong Kong through telehealth and multi-institutional collaboration. Head Neck. 2020 Jul;42(7):1454-1459. doi: 10.1002/hed.26226. Epub 2020 May 7.

    PubMed 32357277
  • Lonergan PE, Washington Iii SL, Branagan L, Gleason N, Pruthi RS, Carroll PR, Odisho AY. Rapid Utilization of Telehealth in a Comprehensive Cancer Center as a Response to COVID-19: Cross-Sectional Analysis. J Med Internet Res. 2020 Jul 6;22(7):e19322. doi: 10.2196/19322.

    PubMed 32568721
  • Pramesh CS, Badwe RA. Cancer Management in India during Covid-19. N Engl J Med. 2020 May 14;382(20):e61. doi: 10.1056/NEJMc2011595. Epub 2020 Apr 28. No abstract available.

    PubMed 32343498
  • van de Haar J, Hoes LR, Coles CE, Seamon K, Frohling S, Jager D, Valenza F, de Braud F, De Petris L, Bergh J, Ernberg I, Besse B, Barlesi F, Garralda E, Piris-Gimenez A, Baumann M, Apolone G, Soria JC, Tabernero J, Caldas C, Voest EE. Caring for patients with cancer in the COVID-19 era. Nat Med. 2020 May;26(5):665-671. doi: 10.1038/s41591-020-0874-8. Epub 2020 Apr 16.

    PubMed 32405058
  • Wong ZW, Cross HL. Telehealth in cancer care during the COVID-19 pandemic. Med J Aust. 2020 Sep;213(5):237-237.e1. doi: 10.5694/mja2.50740. Epub 2020 Aug 16. No abstract available.

    PubMed 32803783
  • Dickinson R, Hall S, Sinclair JE, Bond C, Murchie P. Using technology to deliver cancer follow-up: a systematic review. BMC Cancer. 2014 May 3;14:311. doi: 10.1186/1471-2407-14-311.

    PubMed 24885758
  • Finnane A, Dallest K, Janda M, Soyer HP. Teledermatology for the Diagnosis and Management of Skin Cancer: A Systematic Review. JAMA Dermatol. 2017 Mar 1;153(3):319-327. doi: 10.1001/jamadermatol.2016.4361.

    PubMed 27926766
  • Kubendran S, Sivamurthy S, Schaefer GB. A novel approach in pediatric telegenetic services: geneticist, pediatrician and genetic counselor team. Genet Med. 2017 Nov;19(11):1260-1267. doi: 10.1038/gim.2017.45. Epub 2017 Apr 27.

    PubMed 28471436
  • Agha Z, Schapira RM, Laud PW, McNutt G, Roter DL. Patient satisfaction with physician-patient communication during telemedicine. Telemed J E Health. 2009 Nov;15(9):830-9. doi: 10.1089/tmj.2009.0030.

    PubMed 19919189
  • Hennemann-Krause L, Lopes AJ, Araujo JA, Petersen EM, Nunes RA. The assessment of telemedicine to support outpatient palliative care in advanced cancer. Palliat Support Care. 2015 Aug;13(4):1025-30. doi: 10.1017/S147895151400100X. Epub 2014 Aug 27.

    PubMed 25159308
  • Sabesan S, Larkins S, Evans R, Varma S, Andrews A, Beuttner P, Brennan S, Young M. Telemedicine for rural cancer care in North Queensland: bringing cancer care home. Aust J Rural Health. 2012 Oct;20(5):259-64. doi: 10.1111/j.1440-1584.2012.01299.x.

    PubMed 22998200
  • Buchanan AH, Datta SK, Skinner CS, Hollowell GP, Beresford HF, Freeland T, Rogers B, Boling J, Marcom PK, Adams MB. Randomized Trial of Telegenetics vs. In-Person Cancer Genetic Counseling: Cost, Patient Satisfaction and Attendance. J Genet Couns. 2015 Dec;24(6):961-70. doi: 10.1007/s10897-015-9836-6. Epub 2015 Apr 3.

    PubMed 25833335
  • Schwartz MD, Valdimarsdottir HB, Peshkin BN, Mandelblatt J, Nusbaum R, Huang AT, Chang Y, Graves K, Isaacs C, Wood M, McKinnon W, Garber J, McCormick S, Kinney AY, Luta G, Kelleher S, Leventhal KG, Vegella P, Tong A, King L. Randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer. J Clin Oncol. 2014 Mar 1;32(7):618-26. doi: 10.1200/JCO.2013.51.3226. Epub 2014 Jan 21.

    PubMed 24449235
  • Thaker DA, Monypenny R, Olver I, Sabesan S. Cost savings from a telemedicine model of care in northern Queensland, Australia. Med J Aust. 2013 Sep 16;199(6):414-7. doi: 10.5694/mja12.11781.

    PubMed 24033216
  • Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect. 2001 Jun;4(2):99-108. doi: 10.1046/j.1369-6513.2001.00140.x.

    PubMed 11359540

Questions about this trial

What is this clinical trial studying?

An observational study of Genetic Counselling, run by National Cancer Centre, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ryan Tan (+65 6436 8000, ryan.shea.tan.y.c@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genomics Outcome Scale (time frame: Up to 2 weeks after consultation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04738708, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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