Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001582842
Ethics application status
Approved
Date submitted
5/10/2021
Date registered
19/11/2021
Date last updated
4/08/2023
Date data sharing statement initially provided
19/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The PersOnalising gEneTIc Counselling (POETIC) Trial: Testing the implementation and effectiveness of an intervention to personalise genetic counselling
Scientific title
Testing a genetics-specific patient screening tool to personalise cancer genetic counselling and determine the impact on patient empowerment
Secondary ID [1] 305379 0
None
Universal Trial Number (UTN)
U1111-1269-5149
Trial acronym
POETIC
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Inherited predisposition to cancer 323829 0
Condition category
Condition code
Human Genetics and Inherited Disorders 321336 321336 0 0
Other human genetics and inherited disorders
Cancer 321606 321606 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321850 0
Early detection / Screening
Intervention code [2] 322053 0
Behaviour
Comparator / control treatment
Patients receiving usual care will form the control group who will receive the current standard of genetic counselling where the GPRI is not used.

Genetic counselling is provided by clinicians who are employed in clinical genetics services and include genetic counsellors, clinical geneticists, clinical genetics fellows, and other medical specialists. As described by the Human Genetics Society of Australasia, genetic counselling is a communication process, which aims to help individuals, couples and families understand and adapt to the medical, psychological, familial and reproductive implications of the genetic contribution to specific health conditions. The content and process of genetic counselling is dependent on the skills and experience of the clinician conducting the genetics appointment. Participants in the control group (Group 1) will receive standard genetic counselling, as described above.
Control group
Active

Outcomes
Primary outcome [1] 329120 0
Patient empowerment measured by the Genetic Counselling Outcome Scale (GCOS-24). The GCOS-24 is validated to measure change from pre- to post-genetic counselling. A minimum Clinically Important Difference has been established as an increase in GCOS-24 score of 10 points.
Timepoint [1] 329120 0
Baseline, 2 weeks after first genetics appointment, 2 weeks after second genetics appointment, 6 months after receiving genetic test results.
Secondary outcome [1] 401539 0
Patient satisfaction measured using the Genetic Counselling Satisfaction Scale (Elliott et al.. Journal of Genetic Counseling, 2014. 23(5):881-889.)
Timepoint [1] 401539 0
Q2: 2 weeks after first genetics appointment
Q3: 2 weeks after second genetics appointment
Secondary outcome [2] 401540 0
Psychosocial impact of receiving genetic test results measured using the Multidimensional Impact of Cancer Risk Assessment (MICRA)
Timepoint [2] 401540 0
Q3: 2 weeks after second genetics appointment
Secondary outcome [3] 401541 0
Patient adaptation to inherited cancer risk measured using the Psychosocial Adaption Scale (PAS)
Timepoint [3] 401541 0
Q3: 2 weeks after second genetics appointment
Q4: 6 months after second genetics appointment
Secondary outcome [4] 402346 0
Uptake of cancer risk management strategies measured using purpose designed questions
Timepoint [4] 402346 0
Q4: 6 months after second genetics appointment
Secondary outcome [5] 402347 0
Communication of genetic information to at-risk relatives measured using purpose designed questions
Timepoint [5] 402347 0
Q4: 6 months after second genetics appointment
Secondary outcome [6] 402348 0
Duration of genetics appointment measured by audio recording genetics appointments
Timepoint [6] 402348 0
First and second genetics appointments
Secondary outcome [7] 402349 0
Identification by clinicians of patients' psychosocial needs during an appointment will be measured by a composite of audio recording the genetics appointments and through completion of the clinician checklist
Timepoint [7] 402349 0
Audio recordings: First and second genetics appointments
Clinician checklist: After each genetics appointment
Secondary outcome [8] 402350 0
Number of follow up supports provided to patients after genetics appointments will be measured by collecting clinical data
Timepoint [8] 402350 0
At the conclusion of the study
Secondary outcome [9] 403171 0
Types of follow up supports provided to patients after genetics appointments will be measured by collecting clinical data
Timepoint [9] 403171 0
At the conclusion of the study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have a known cognitive impairment;
• Eligible for the PRiMo study (HREC no. HREC/64060/PMCC; ACTRN12621000009819).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
19/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
246
Accrual to date
121
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20651 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 20652 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 35441 0
3000 - Melbourne
Recruitment postcode(s) [2] 35442 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 309748 0
Government body
Name [1] 309748 0
Victorian Cancer Agency
Country [1] 309748 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street, Melbourne, Victoria 3000
Country
Australia
Secondary sponsor category [1] 310856 0
None
Name [1] 310856 0
Address [1] 310856 0
Country [1] 310856 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309504 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 309504 0
305 Grattan St, Melbourne, Victoria 3000
Ethics committee country [1] 309504 0
Australia
Date submitted for ethics approval [1] 309504 0
08/11/2021
Approval date [1] 309504 0
22/12/2021
Ethics approval number [1] 309504 0
HREC/78093/PMCC

Summary
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.
Trial website
Trial related presentations / publications
Public notes
The Genetic Psychosocial Risk Instrument (GPRI) is a 20-item validated screening instrument designed to identify psychological risk factors that predict distress in adult patients undergoing genetic testing. We hypothesise that by using the GPRI in genetics appointments, patient needs will be more reliably identified and genetic counselling can be personalized to address needs and improve patient outcomes, including empowerment and adaptation. Group 2 participants have their genetics appointments with the results of the GPRI incorporated by the clinician into the genetic counselling process.

The effectiveness of the GPRI intervention will be assessed using the Framework for Outcomes of Clinical commUnication Services for Genetic Counselling as guide. Implementation of the GPRI will be concurrently assessed guided by the implementation outcomes framework. The cost effectiveness and other implementation outcomes will be assessed from the perspective of the patients, clinicians, and the healthcare service. At the conclusion of this study, this highest level of RCT evidence plus the implementation assessment will support the planned and immediate implementation of the GPRI routinely in the Parkville Familial Cancer Centre.

Contacts
Principal investigator
Name 114386 0
Dr Laura Forrest
Address 114386 0
Peter MacCallum Cancer Centre
305 Grattan St, Melbourne
Victoria 3000
Country 114386 0
Australia
Phone 114386 0
+61 03 8559 6191
Fax 114386 0
Email 114386 0
laura.forrest@petermac.org
Contact person for public queries
Name 114387 0
Dr Laura Forrest
Address 114387 0
Peter MacCallum Cancer Centre
305 Grattan St, Melbourne
Victoria 3000
Country 114387 0
Australia
Phone 114387 0
+61 03 8559 6191
Fax 114387 0
Email 114387 0
laura.forrest@petermac.org
Contact person for scientific queries
Name 114388 0
Dr Laura Forrest
Address 114388 0
Peter MacCallum Cancer Centre
305 Grattan St, Melbourne
Victoria 3000
Country 114388 0
Australia
Phone 114388 0
+61 03 8559 6191
Fax 114388 0
Email 114388 0
laura.forrest@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are unsure what IPD we will produce that may be useful and able to share. We will update this at a later time.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.