NCT04738708

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress93%
Feb 2021Oct 2026

First Submitted

Initial submission to the registry

January 31, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

5.7 years

First QC Date

January 31, 2021

Last Update Submit

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)

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

Interventions

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

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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

Related Publications (26)

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    PMID: 22998200BACKGROUND
  • 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.

    PMID: 25833335BACKGROUND
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    PMID: 24449235BACKGROUND
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    PMID: 24033216BACKGROUND
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    PMID: 24458016BACKGROUND
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    PMID: 24499499BACKGROUND
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    PMID: 21255005BACKGROUND
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    PMID: 31571202BACKGROUND
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    PMID: 30496830BACKGROUND
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    PMID: 19736695BACKGROUND
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    PMID: 31361378BACKGROUND
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    PMID: 29243007BACKGROUND
  • 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.

    PMID: 21799430BACKGROUND

Study Officials

  • Ryan Tan

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

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

Locations