None listed
Conditions
Brief summary
Genetic testing has become a central focus in cancer care due to the ability to identify individuals with an inherited predisposition to cancer and inform prognosis and treatment options. This trial is investigating the effectiveness of using the Genetic Psychosocial Risk Instrument (GPRI) in genetic counselling appointments for people with an inherited predisposition to cancer (for example a family history of cancer). Who is it for? You may be eligible for this trial if you are an adult aged 18 years and above and you have an increased risk of a hereditary cancer syndrome. Patients attending the Parkville Familial Cancer Centre for genetic testing will be invited to participate. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either the GPRI intervention arm, or a standard care control arm. Participants in the intervention arm will complete baseline questionnaires and the GPRI online before their first appointment. During the first appointment, the clinician taking the appointment will use the results of the GPRI to inform the genetic counselling provided while discussing genetic testing. Participants will then return approximately 8 weeks later for their second genetics appointment where they will receive their genetic test results. Prior to this second appointment, participants will complete the GPRI online again. During this second appointment, the clinician will again use the results of the GPRI to inform the genetic counselling process when discussing genetic test results and personal and family implications. Participants in the control arm will also complete the baseline questionnaires but will not complete the GPRI. Instead, these participants will receive the current standard of genetic counselling which involves the clinician facilitating communication about the medical, psychological, and reproductive implications of an inherited cancer predisposition. All participants will be invited to complete three subsequent questionnaires about their experiences throughout the study period up to 6 months after the second genetics appointment. It is hoped that this study will demonstrate that the GPRI tool is useful and may help patients with an increased risk of cancer to feel more empowered about their health and future treatment options.
Interventions
A hybrid type 2 effectiveness-implementation trial has been designed to assess the effectiveness of using the Genetic Psychosocial Risk Instrument (GPRI) in genetic counselling appointments while also assessing the implementation strategy. Patients will be randomised to Group 1 (usual care) or Group 2 (GPRI intervention).
Patients attending the Parkville Familial Cancer Centre for genetic testing will be invited to participate. Participants will complete an online baseline questionnaire (Q1) whi
A hybrid type 2 effectiveness-implementation trial has been designed to assess the effectiveness of using the Genetic Psychosocial Risk Instrument (GPRI) in genetic counselling appointments while also assessing the implementation strategy. Patients will be randomised to Group 1 (usual care) or Group 2 (GPRI intervention). Patients attending the Parkville Familial Cancer Centre for genetic testing will be invited to participate. Participants will complete an online baseline questionnaire (Q1) which will facilitate randomisation prior to their first appointment. Group 2 participants will complete the GPRI online for their clinicians’ use during their first and second genetics appointments. The GPRI will be delivered as an online survey and includes 19 items, which have either binary yes/no responses or 5 point Likert scale responses. The tool is estimated to take 5 minutes to complete, and participants will complete the GPRI within 3 days of their genetics appointments. During the first genetics appointment, clinicians will provide genetic counselling including discussion about genetic testing. During the second genetics appointment, clinicians will provide genetic counselling including results of genetic testing. For participants in group 2, their GPRI will be available to the clinician to incorporate into their genetic counselling and provision of care during their first and second genetics appointment. All participants will be invited to complete three subsequent questionnaires about their experiences throughout the study period: two weeks after their first appointment (Q2), two weeks after their second genetics appointment (Q3), and six months after their second genetics appointment (Q4). Clinicians will be trained in how to interpret GPRI scores. Training includes attending a 30 minute educational webinar designed especially for this study and a study manual for clinicians is available as a resource. All appointments will be audio-recorded for duration and for frequency of psychosocial needs identified and addressed by the clinician. After each appointment, clinicians will complete a brief checklist summarising each of the GPRI domains. Clinicians also will be asked to complete a structured interview about their experiences of using the GPRI and the feasibility and sustainability of routine use after the conclusion of the trial. Clinical and administrative data (e.g., the number and type of referrals for psychosocial support, time taken to write letters to at-risk family members, referrals made for risk management) will be collected to aid health economic analysis.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Individuals who have an increased risk of a hereditary cancer syndrome; • Aged 18 years or older; • Literate in English; • Reasonable internet access and capacity to complete computer-based surveys.
Exclusion criteria
• Have a known cognitive impairment; • Eligible for the PRiMo study (HREC no. HREC/64060/PMCC; ACTRN12621000009819).
Outcome results
None listed