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NCT04725565
Genetics Adviser: Evaluating a Digital Decision Support Tool for Genetic Results
NA trial testing Genetics ADvISER Decision Aid Plus Standard Genetic Counselling in Cancer in 133 participants. Completed in 6 April 2024.
20 April 2023
Quick facts
| Lead sponsor | Unity Health Toronto |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 133 |
| Start date | 22 June 2021 |
| Primary completion | 20 April 2023 |
| Estimated completion | 6 April 2024 |
| Sites | 3 locations across Canada |
Drugs / interventions tested
- Genetics ADvISER Decision Aid Plus Standard Genetic Counselling
- Standard Genetic Counseling
Conditions studied
- Cancer — all drugs for Cancer →
Sponsor
Unity Health Toronto — full company profile →
Who can join
18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Oncologists are increasingly using genomic sequencing to diagnose and optimize care for their patients. A consequence of this technology is its capacity to detect a patient's risk for thousands of current and future conditions or diseases. Guidelines recommend doctors allow patients to choose which results they wish to receive before ordering the test. It is not feasible to counsel patients on the thousands of possible results because of the limited clinical resources and genomics expertise. Decision aids (DAs) can fill this gap, however there are no DAs to guide patients' decisions about results from genomic sequencing. A DA prototype was developed (GenomicsADvISER.com), the first DA of its kind. This study will transform the DA prototype into an interactive, adaptable and patient-centred digital decision support tool (Genetics ADvISER) via user-centred design methods. The objective of this study is to evaluate the effectiveness of Genetics ADvISER in an RCT with patients being offered results from genomic sequencing. Results of this trial will be used to establish whether the Genetics ADvISER is effective to use in practice. This could fill a critical clinical care gap, improve health outcomes and service use by reducing counselling burden as well as overuse, underuse and misuse - concerns of policy makers seeking to address the triple aims of health care.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Decision aids for people facing health treatment or screening decisions.
Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6 -
Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery.
Shickh S, Hirjikaka D, Clausen M, Kodida R, et al · · 2022 · cited 17× · PMID 35487723 · DOI 10.1136/bmjopen-2022-060899
Verify or expand the search:
- PubMed search for NCT04725565
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04725565 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Unity Health Toronto
- Last refreshed: 31 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04725565.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing