Clinical trial · Interventional
Genetics Adviser: Evaluating a Digital Decision Support Tool for Genetic Results
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetics ADvISER Decision Aid Plus Standard Genetic Counselling | Behavioral | — | UNRESOLVED |
| Standard Genetic Counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Genetics ADviSER Decision Aid Plus Standard Genetic Counselling
- description
- Participants in the intervention arm will use the Genetics ADviSER to learn about genomic sequencing and to select which results they would like to receive from genomics sequencing results. After using the Genetics ADviSER decision aid they will speak with genetic counselor to discuss their choices and to finalized their selection.
- interventionNames
- Behavioral: Genetics ADvISER Decision Aid Plus Standard Genetic Counselling
- type
- ACTIVE_COMPARATOR
- label
- Standard Genetic Counselling Only
- description
- Participants will speak with a genetic counsellor over the phone to learn about genomic sequencing and select which incidental findings they would like to receive from genomic sequencing.
- interventionNames
- Behavioral: Standard Genetic Counseling
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previous control participants from the Incidental Genomics study who have given permission to be re-contacted for related research or a patient who has undergone germline genetic testing (single gene or panel) and received a negative or inconclusive result. * 18 years old or older * Speak and read English. Exclusion Criteria: For participants newly recruited (not part of parent trial CTO# 0819) * Received positive panel testing or panel sequencing * Have not had germline single gene testing related to their primary cancer condition (e.g., BRCA1/2 for breast/ovarian cancer, MLH, MSH, PMS colorectal cancer, etc.) * Received a positive germline genetic test for a cancer gene mutation (e.g., BRCA1/2, MLH, MSH, PMS, APC, MUTYH, etc.) * Currently under cancer treatment * In stage 4, progressive metastatic cancer For all * Do not speak or read English * Under 18 years of age
References
Publications (1)
- DERIVEDShickh S, Hirjikaka D, Clausen M, Kodida R, Mighton C, Reble E, Sam J, Panchal S, Aronson M, Graham T, Armel SR, Glogowski E, Elser C, Eisen A, Carroll JC, Shuman C, Seto E, Baxter NN, Scheer A, Shastri-Estrada S, Feldman G, Thorpe KE, Schrader KA, Lerner-Ellis J, Kim RH, Faghfoury H, Bombard Y. Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery. BMJ Open. 2022 Apr 29;12(4):e060899. doi: 10.1136/bmjopen-2022-060899. PMID 35487723