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.
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
- Recruiting
National Cancer Centre Singapore
Singapore, 169610
Ryan Tan
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.
- Conditions
- Genetic Counselling
- 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 group | Role | What 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.
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)
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
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
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.
- First posted4 Feb 2021
- Study start1 Feb 2021
- Primary completion6 Oct 2026 (estimated)
- Study completion6 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Genetic CounsellingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Tan, Principal investigator, National Cancer Centre, Singapore
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 32357277Lonergan 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 32568721Pramesh 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 32343498van 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 32405058Wong 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 32803783Dickinson 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 24885758Finnane 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 27926766Kubendran 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 28471436Agha 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 19919189Hennemann-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 25159308Sabesan 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 22998200Buchanan 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 25833335Schwartz 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 24449235Thaker 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 24033216Marteau 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telegenetics or In-Person Genetic Counselling: A Comparison of Clinical Outcomes and Cost
- ClinicalTrials.gov ID
- NCT04738708
- Acronym / sponsor ID
- 002.1
- Conditions
- Genetic Counselling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 6 Oct 2026 (estimated)
- Study completion
- 6 Oct 2026 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling. | – | Other: 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) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.Patients are given a series of questions evaluating cognitive and psychosocial outcomes, either via hardcopy in-person or online internet-facing questionnaire. | Other | Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling. |
Primary outcome
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.
3 secondary outcomes
Adapted Multidimensional Measure of Informed Choice (MMIC) for Hereditary Breast and Ovarian Cancer (HBOC) and Lynch
Time frame: Up to 2 weeks after consultation
Genetic Counselling Satisfaction Scale
Time frame: Up to 2 weeks after consultation
Telehealth Patient Survey
Time frame: Up to 2 weeks after consultation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 32357277Lee 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.
- Background: PubMed 32568721Lonergan 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.
- Background: PubMed 32343498Pramesh 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.
- Background: PubMed 32405058van 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.
- Background: PubMed 32803783Wong 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.
- Background: PubMed 24885758Dickinson 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.
- Background: PubMed 27926766Finnane 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.
- Background: PubMed 28471436Kubendran 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.
- Background: PubMed 19919189Agha 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.
- Background: PubMed 25159308Hennemann-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.
- Background: PubMed 22998200Sabesan 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.
- Background: PubMed 25833335Buchanan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Tan principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
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.