Telegenetics or In-Person Genetic Counselling

Genetic Counselling Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04738708
• Other study ID #: 002.1
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: National Cancer Centre, Singapore
• Contact: Ryan Tan
• Phone: +65 6436 8000
• Email: ryan.shea.tan.y.c[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genetic Counselling

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (26)

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. — View Citation

Bannon 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. — View Citation

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. — View Citation

Chan 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. — View Citation

Cohn 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. — View Citation

DeMarco 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. — View Citation

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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. — View Citation

Grant 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

McAllister 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. Erratum In: Clin Genet. 2011 Jul;80(1):99. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Thomas 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. — View Citation

Vadaparampil 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. — View Citation

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. Erratum In: Nat Med. 2020 Jul;26(7):1146. — View Citation

Voils 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. — View Citation

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. — View Citation

Yuen 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. — View Citation

Zilliacus 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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 2 weeks after consultation
Secondary	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.	Up to 2 weeks after consultation
Secondary	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.	Up to 2 weeks after consultation