Genetics Adviser: Evaluating a Digital Decision Support Tool for Genetic Results

NCT04725565 | Completed

• 1 other identifier: 3400
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 3

Brief Summary

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

Cancer

Keywords

Incidental Findings; Genomic Sequencing; Randomized Controlled Trial; Decision Aid; Clinical Utility; Personal Utility

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale (DCS)

  The Ottawa Decision Support Framework measure of decisional conflict, a 16 item scale - developed by O'Connor et al. Each item is scored 1-5 and a total score on the DCS is calculated by summing all items on the DCS and then dividing by 16, giving a final score between 1 and 5. A lower score on the DCS indicates lower level of decisional conflict.

  1 day

Secondary Outcomes (7)

• Knowledge

  Assessed at baseline, immediately after baseline/ post intervention, at two weeks, 2 months and 4 months.

• Satisfaction with Decision Scale (SWD)

  Assessed immediately after baseline/ post intervention, at two weeks, 2 months and 4 months.

• Preparation for Decision Making scale (PrepDM)

  Assessed immediately after baseline/ post intervention, at two weeks, 2 months and 4 months.

• State-Trait Anxiety Inventory

  Assessed at baseline, immediately after baseline/ post intervention, at two weeks, 2 months and 4 months.

• Hospital Anxiety and Depression Scale (HADS)

  Assessed at baseline, immediately after baseline/post intervention, at two weeks, 2 months and 4 months.

Study Arms (2)

Genetics ADviSER Decision Aid Plus Standard Genetic Counselling

EXPERIMENTAL

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.

Behavioral: Genetics ADvISER Decision Aid Plus Standard Genetic Counselling

Standard Genetic Counselling Only

ACTIVE COMPARATOR

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.

Behavioral: Standard Genetic Counseling

Interventions

Genetics ADvISER Decision Aid Plus Standard Genetic Counselling BEHAVIORAL

The decision aid will educate patients about the types of incidental finding they can learn from genomic sequencing and will give them opportunity select what types of results they would like to receive.

Genetics ADviSER Decision Aid Plus Standard Genetic Counselling

Standard Genetic Counseling BEHAVIORAL

Standard Genetic counseling to learn about and select incidental results from genomic sequencing.

Standard Genetic Counselling Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years old or older
• Speak and read English.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (3)

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Princess Margret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location

Related Publications (1)

• Shickh 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 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Yvonne Bombard, PhD

  St. Michael's Hospital and University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 26, 2021
• Study Start: June 22, 2021
• Primary Completion: April 20, 2023
• Study Completion: April 6, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: for 5 years after study has been completed and the trail data has been published.
• Access Criteria: Data will be made available to research who are interested in / conducting similar research in this field. This data will be available upon request, keeping with research ethics procedures.

Locations

CA (3)