Telegenetics or In-Person Genetic Counselling
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2021
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 6, 2026
April 28, 2026
April 1, 2026
5.7 years
January 31, 2021
April 26, 2026
Conditions
Outcome Measures
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.
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
Up to 2 weeks after consultation
Genetic Counselling Satisfaction Scale
Up to 2 weeks after consultation
Telehealth Patient Survey
Up to 2 weeks after consultation
Study Arms (1)
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)
Interventions
Patients are given a series of questions evaluating cognitive and psychosocial outcomes, either via hardcopy in-person or online internet-facing questionnaire.
Eligibility Criteria
Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Centre Singapore
Singapore, 169610, Singapore
Related Publications (26)
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.
PMID: 32357277BACKGROUNDLonergan 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.
PMID: 32568721BACKGROUNDPramesh 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.
PMID: 32343498BACKGROUNDvan 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.
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PMID: 24885758BACKGROUNDFinnane 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.
PMID: 27926766BACKGROUNDKubendran 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.
PMID: 28471436BACKGROUNDAgha 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.
PMID: 19919189BACKGROUNDHennemann-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.
PMID: 25159308BACKGROUNDSabesan 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.
PMID: 22998200BACKGROUNDBuchanan 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.
PMID: 25833335BACKGROUNDSchwartz 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.
PMID: 24449235BACKGROUNDThaker 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.
PMID: 24033216BACKGROUNDMarteau 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.
PMID: 11359540BACKGROUNDVadaparampil ST, Quinn GP, Small BJ, McIntyre J, Loi CA, Closser Z, Gwede CK. A pilot study of hereditary breast and ovarian knowledge among a multiethnic group of Hispanic women with a personal or family history of cancer. Genet Test Mol Biomarkers. 2010 Feb;14(1):99-106. doi: 10.1089/gtmb.2009.0088.
PMID: 19929403BACKGROUNDCohn J, Blazey W, Tegay D, Harper B, Koehler S, Laurent B, Chan V, Jung MK, Krishnamachari B. Physician Risk Assessment Knowledge Regarding BRCA Genetics Testing. J Cancer Educ. 2015 Sep;30(3):573-9. doi: 10.1007/s13187-014-0724-9.
PMID: 25234477BACKGROUNDChan V, Blazey W, Tegay D, Harper B, Koehler S, Laurent B, Lipka S, Cohn J, Jung MK, Krishnamachari B. Impact of academic affiliation and training on knowledge of hereditary colorectal cancer. Public Health Genomics. 2014;17(2):76-83. doi: 10.1159/000356938. Epub 2014 Jan 22.
PMID: 24458016BACKGROUNDBannon SA, Mork M, Vilar E, Peterson SK, Lu K, Lynch PM, Rodriguez-Bigas MA, You YN. Patient-reported disease knowledge and educational needs in Lynch syndrome: findings of an interactive multidisciplinary patient conference. Hered Cancer Clin Pract. 2014 Feb 5;12(1):1. doi: 10.1186/1897-4287-12-1.
PMID: 24499499BACKGROUNDMcAllister M, Wood AM, Dunn G, Shiloh S, Todd C. The Genetic Counseling Outcome Scale: a new patient-reported outcome measure for clinical genetics services. Clin Genet. 2011 May;79(5):413-24. doi: 10.1111/j.1399-0004.2011.01636.x. Epub 2011 Feb 14.
PMID: 21255005BACKGROUNDYuen J, Lee SY, Courtney E, Lim J, Soh H, Li ST, Chen Y, McAllister M, Fenwick EK, Ngeow J. Evaluating empowerment in genetic counseling using patient-reported outcomes. Clin Genet. 2020 Feb;97(2):246-256. doi: 10.1111/cge.13646. Epub 2019 Oct 23.
PMID: 31571202BACKGROUNDGrant PE, Pampaka M, Payne K, Clarke A, McAllister M. Developing a short-form of the Genetic Counselling Outcome Scale: The Genomics Outcome Scale. Eur J Med Genet. 2019 May;62(5):324-334. doi: 10.1016/j.ejmg.2018.11.015. Epub 2018 Nov 26.
PMID: 30496830BACKGROUNDDeMarco TA, Peshkin BN, Mars BD, Tercyak KP. Patient satisfaction with cancer genetic counseling: a psychometric analysis of the Genetic Counseling Satisfaction Scale. J Genet Couns. 2004 Aug;13(4):293-304. doi: 10.1023/b:jogc.0000035523.96133.bc.
PMID: 19736695BACKGROUNDThomas C, McAllister M. Establishing the minimum clinically important difference for the Genetic Counseling Outcome Scale (GCOS-24). J Genet Couns. 2019 Oct;28(5):1003-1010. doi: 10.1002/jgc4.1152. Epub 2019 Jul 30.
PMID: 31361378BACKGROUNDVoils CI, Venne VL, Weidenbacher H, Sperber N, Datta S. Comparison of Telephone and Televideo Modes for Delivery of Genetic Counseling: a Randomized Trial. J Genet Couns. 2018 Apr;27(2):339-348. doi: 10.1007/s10897-017-0189-1. Epub 2017 Dec 15.
PMID: 29243007BACKGROUNDZilliacus EM, Meiser B, Lobb EA, Kelly PJ, Barlow-Stewart K, Kirk JA, Spigelman AD, Warwick LJ, Tucker KM. Are videoconferenced consultations as effective as face-to-face consultations for hereditary breast and ovarian cancer genetic counseling? Genet Med. 2011 Nov;13(11):933-41. doi: 10.1097/GIM.0b013e3182217a19.
PMID: 21799430BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Tan
National Cancer Centre, Singapore
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2021
First Posted
February 4, 2021
Study Start
February 1, 2021
Primary Completion (Estimated)
October 6, 2026
Study Completion (Estimated)
October 6, 2026
Last Updated
April 28, 2026
Record last verified: 2026-04