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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12624000091505
Ethics application status
Approved
Date submitted
21/11/2023
Date registered
1/02/2024
Date last updated
1/02/2024
Date data sharing statement initially provided
1/02/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
PhaRmacogEnomiC medIcines optimiSatIon for peOple with caNcer – a multicentre teletrial enabled Interrupted Time Series trial (PRECISION-ITS): Pharmacogenomics Education & Implementation Program for Pharmacists
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Scientific title
PhaRmacogEnomiC medIcines optimiSatIon for peOple with caNcer – a multicentre teletrial enabled Interrupted Time Series trial (PRECISION-ITS): Pharmacogenomics Education & Implementation Program for Pharmacists
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Secondary ID [1]
310971
0
MRFMMIP000011
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Universal Trial Number (UTN)
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Trial acronym
PRECISION-ITS
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Linked study record
Linked to the primary trial:
1. PhaRmacogEnomiC medIcines optimiSatIon for peOple with caNcer – a multicentre teletrial enabled Interrupted Time Series trial (PRECISION-ITS): Medication safety outcomes in the Pharmacogenomics primary study and discovery sub-study
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Health condition
Health condition(s) or problem(s) studied:
Cancer and other malignant neoplasms
332057
0
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Condition category
Condition code
Cancer
328780
328780
0
0
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Any cancer
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Public Health
329032
329032
0
0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A pharmacogenomics (PGx) education and implementation program will be developed and tested on pharmacists participating in the PRECISION-ITS multisite interrupted time series tele-trial. The PGx education/implementation program will run concurrently with the primary PGx trial. In the primary trial, pharmacogenomics pharmacists at the primary site are responsible for all PGx consenting and follow up, whereas these activities may be delegated to pharmacists at regional tele-sites in Time Series 2 who have completed the PRECISION-ITS Pharmacogenomics Education/Implementation program. Pharmacists recruited to PRECISION-ITS will be enrolled in the PGx education/implementation program to acquire PGx knowledge and to discuss PGx service implementation plans, successes and barriers. The program will focus on PGx in the context of adults receiving systemic anticancer therapies, establishing a framework which may then be applied to other settings (such as paediatric oncology) and healthcare disciplines. Development of the PGx education/implementation program will occur in Time Series 1 (over 10-12 months). Delivery of the PGx education/implementation program will occur within 6 months before Time Series 2 participant accrual in the primary PGx trial (to allow for credentialed pharmacists at regional tele-sites to conduct primary PGx trial follow up assessments). Time Series 2 in the Primary PGx trial will commence 3-4 months after Time Series 1 participant accrual is completed.
1. Education Program
The PGx education program will feature up to 9 online education modules on a learning management system written and developed by the PRECISION-ITS Education working group. The education working group consists of pharmacists, clinical educators, consumer representatives, clinical geneticists, genetic counsellors, and experts in pharmacogenomics and implementation science, who will meet weekly to biweekly to create/review module content. Program development will occur in Time Series 1 across 10-12 months, and will be informed by internationally recognized web content accessibility guidelines standards. The program will incorporate key program elements of flipped classroom, clinical case vignettes, self-test multiple choice/short answer questions, reflective (v)logs, expert pharmacist/ clinician-moderated discussion boards that will connect participants in a learning community, and three virtual educational outreach sessions to facilitate local PGx service implementation at regional Teletrial sites using guided reflection.
Knowledge, Attitudes and Practices (KAP) surveys regarding PGx for consumers and healthcare professionals practicing in oncology within Australia (designed specifically for this study) will also be undertaken to provide a needs assessment to inform program design. Separate surveys will be developed for the adult and paediatric oncology settings. One set of surveys will be targeted at consumers/carers (who have had or cared for someone who was treated for cancer in the Australian healthcare system). The other set of surveys will be targeted at health care professionals working in cancer care (e.g. oncologist, haematologists, pharmacists & nurses). KAP surveys will be distributed at Month 6 and are to be completed/evaluated at Month 9 in preparation for program finalisation. The Theoretical Domains Framework (TDF) and Bradshaw’s model of needs were used to develop a holistic, stakeholder-centred needs assessment that will elicit the needs of health care professionals and consumers. These behaviour change frameworks for a targeted education program will be embedded within PRECISION-ITS’s learning health system to provide value by addressing pharmacists’ unmet information needs, and extending their scope of practice. Content will be hosted on a globally recognised Learning Management System that supports creating and deploying custom role-specific courses to craft groups.
Modules will be developed from established US/UK competencies for pharmacists and other health professionals; reviewed/assessed for appropriateness in the context of adults receiving anticancer treatment; and designed with implementation science theory to ensure successful integration/sustainability of PGx-guided medicines optimization within and beyond the trial, Although the modules are targeted at pharmacists, modules have been written such that other healthcare professionals may undertake these modules beyond the trial. The modules will undergo two rounds of user testing during Time Series 1 by 5-9 pharmacists at the primary site, with an aim to deliver the final program to 1-2 pharmacists per PRECISION-ITS site. Each education module will take approximately 30 minutes to complete, with an aim for trainees to complete all modules within 2-3 months. The education program will incorporate key program elements of flipped classroom, clinical case vignettes, self-test multiple choice/short answer questions, reflective (v)logs and expert pharmacist/clinician-moderated discussion boards.
2. Implementation program
The PGx implementation program will feature 3 educational outreach sessions on facilitation of local PGx service implementation at regional teletrial sites. Outreach sessions will be delivered to pharmacists enrolled in the PRECISION-ITS program by pharmacists within the PRECISION-ITS working group with established experience in clinical education and PGx service implementation. This will consist of three 1-hour virtual sessions occurring before program participation, during program participation, and after implementation of a local PGx service at the regional tele-trial sites.
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Intervention code [1]
327402
0
Behaviour
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Comparator / control treatment
Not applicable, there is no control group for this substudy.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
336591
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Evaluation of initial pharmacogenomics education program for pharmacists.
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Assessment method [1]
336591
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User feedback will be sought in two testing rounds in the design and development phase to collect quantitative and qualitative data assessing website usability. Quantitative data will be from the System Usability Scale (SUS), which will be completed by pharmacists during user testing to assess the developed online education program. The SUS is a simple, ten-item scale where respondents are able to measure/assess a system's usability across multiple areas (e,g, complexity, need for support/training, effectiveness, efficiency and user satisfaction). Overall system usability will be derived from the SUS score (ranging from 0 to 100), which has been previously used in other studies involving healthcare professionals and the cancer setting (Benedict, C., et al., Development of a Web-Based Decision Aid and Planning Tool for Family Building After Cancer (Roadmap to Parenthood): Usability Testing. JMIR Cancer, 2022. 8(2): p. e33304). During both rounds of testing, pharmacists will engage in a think-aloud exercise (where they will verbalise what they are seeing and understanding) when undertaking one-two modules (the same module/s in both rounds), Think-aloud exercises will be audio recorded and the pharmacist's screen will be video recorded to capture how they are navigating the online content. An exit interview will also be conducted with open-ended questions to obtain feedback on likes and dislikes and suggestions for improvement. All feedback will inform design modifications to the program prior to its launch.
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Timepoint [1]
336591
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User testing for initial program to occur at Month 10.
SUS assessments/user testing for initial program to be completed at Month 11.
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Primary outcome [2]
336593
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Evaluation of PRECISION-ITS pharmacist program implementation, according to the Consolidated Framework for Implementation Research (CFIR).
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Assessment method [2]
336593
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Endpoints = Evaluation of implemented pharmacist PGx education/implementation program according to CFIR framework (composite outcome).
There will be 3 educational outreach sessions to facilitate local pharmacogenomic service implementation at regional tele-trial sites. Outreach sessions will take place within 4 weeks before education/implementation program participation, during education/program participation, and within 4 weeks after local pharmacogenomic service implementation at regional tele-trial sites. All educational outreach consultations will be audio and/or video-recorded, and transcripts will be thematically analysed against selected CFIR framework constructs 4 weeks after the last outreach session.
The CFIR framework will be used to determine:
i) the internal and external factors e.g. tension for change, available resources, relative priority influencing successful implementation of a pharmacogenomics service at participants’ workplaces
ii) feasibility, acceptability and perceived impact of the educational outreach according to participants.
The overall implementation program will also be evaluated by participants through an end-user survey (designed specifically for this study) within 4 weeks after participant program completion.
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Timepoint [2]
336593
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CFIR evaluations for outreach sessions to be analysed within 4 weeks after last outreach session.
End-user surveys for implementation program to be assessed 4 weeks after last participant completes program.
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Primary outcome [3]
336841
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Evaluation of PRECISION-ITS pharmacist program implementation, according to the Reach, Efficacy, Adoption, Implementation and Maintenance (RE-AIM) framework.
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Assessment method [3]
336841
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Endpoint = Evaluation of implemented pharmacist PGx education/implementation program according to RE-AIM Framework (composite outcome).
The Reach, Efficacy, Adoption, Implementation and Maintenance (RE-AIM) framework will be used to assess implementation of the program:
1. Reach = measure of the participation by the target population (number of pharmacists enrolled & number of pharmacists enrolled who work within a pharmacogenomics clinical service) and number of downloads of the Purple Pen podcast/s for national dissemination of key practice points derived from the education program content.
2. Efficacy = effectiveness of interventions, this includes proximal measures like feedback on the education program website, the overall education experience and change in KAP.
3. Adoption = number and representativeness of sites that complete all three education outreach sessions
4. Implementation = feasibility, acceptability and perceived impact of education outreach as described above via end-user surveys. The overall implementation program will be evaluated by participants through an end-user survey (designed specifically for this study) within 4 weeks after participant program completion.
5. Maintenance = number of program enrolments/completions/credentialling, and number of downloads of Purple Pen podcast/s.
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Timepoint [3]
336841
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End-user survey to be completed by participants within 4 weeks after program completion.
Program's Reach/Efficacy/Adoption/Implementation to be assessed within 4 weeks after last participant completes program.
Program's Maintenance to be assessed 3 years post program delivery.
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Secondary outcome [1]
428909
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Knowledge of pharmacogenomics amongst consumers/carers in the Australian community.
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Assessment method [1]
428909
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Knowledge of pharmacogenomics testing and dosing interventions will be assessed by case vignettes and agreement with various knowledge statements in the National Knowledge, Attitudes and Perceptions (KAP) Consumer Surveys developed specifically for this study by the PRECISION-ITS working group. Separate surveys will be developed for adult and paediatric oncology settings. The surveys cover pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability.
Survey development will be informed by systemic literature review and expert elicitation (via priority partnership meetings within multidisciplinary health professionals, academics and consumers), with questions framed to understand determinants of behaviour as informed by the Theoretical Domains Framework. The consumer survey is targeted at consumers/carers who have had or cared for someone who was treated for cancer in the Australian healthcare system. The surveys will be distributed electronically via public campaigns through Australian professional and consumer representative groups such as the Clinical Oncology Society of Australia (COSA), and The Society of Hospital Pharmacists of Australia (SHPA) who have endorsed the PRECISION-ITS program as well as other key peak bodies.
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Timepoint [1]
428909
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KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
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Secondary outcome [2]
429805
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Attitudes to pharmacogenomics amongst consumers/carers in the Australian community.
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Assessment method [2]
429805
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Attitudes to pharmacogenomics testing and dosing interventions will be assessed by case vignettes and agreement with various attitude statements in the National KAP Consumer Surveys developed specifically for this study by the PRECISION-ITS working group. Separate surveys will be developed for adult and paediatric oncology settings. The surveys cover pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability.
Survey development will be informed by systemic literature review and expert elicitation (via priority partnership meetings within multidisciplinary health professionals, academics and consumers), with questions framed to understand determinants of behaviour as informed by the Theoretical Domains Framework. The consumer survey is targeted at consumers/carers who have had or cared for someone who was treated for cancer in the Australian healthcare system. The surveys will be distributed electronically via public campaigns through Australian professional and consumer representative groups such as the Clinical Oncology Society of Australia (COSA), and The Society of Hospital Pharmacists of Australia (SHPA) who have endorsed the PRECISION-ITS program as well as other key peak bodies.
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Timepoint [2]
429805
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KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
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Secondary outcome [3]
429806
0
Perceptions to pharmacogenomics amongst consumers/carers in the Australian community.
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Assessment method [3]
429806
0
Perceptions of pharmacogenomics testing and dosing interventions will be assessed by case vignettes and agreement with various belief statements in the National KAP Consumer Surveys developed specifically for this study by the PRECISION-ITS working group. Separate surveys will be developed for adult and paediatric oncology settings. The surveys cover pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability.
Survey development will be informed by systemic literature review and expert elicitation (via priority partnership meetings within multidisciplinary health professionals, academics and consumers), with questions framed to understand determinants of behaviour as informed by the Theoretical Domains Framework. The consumer survey is targeted at consumers/carers who have had or cared for someone who was treated for cancer in the Australian healthcare system. The surveys will be distributed electronically via public campaigns through Australian professional and consumer representative groups such as the Clinical Oncology Society of Australia (COSA), and The Society of Hospital Pharmacists of Australia (SHPA) who have endorsed the PRECISION-ITS program as well as other key peak bodies.
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Timepoint [3]
429806
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KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
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Secondary outcome [4]
429807
0
Acceptability of pharmacogenomics amongst consumers/carers in the Australian community.
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Assessment method [4]
429807
0
Acceptability of pharmacogenomics testing and dosing interventions will be assessed by case vignettes in the National KAP Consumer Surveys developed specifically for this study by the PRECISION-ITS working group. Separate surveys will be developed for adult and paediatric oncology settings. The surveys cover pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability.
Survey development will be informed by systemic literature review and expert elicitation (via priority partnership meetings within multidisciplinary health professionals, academics and consumers), with questions framed to understand determinants of behaviour as informed by the Theoretical Domains Framework. The consumer survey is targeted at consumers/carers who have had or cared for someone who was treated for cancer in the Australian healthcare system. The surveys will be distributed electronically via public campaigns through Australian professional and consumer representative groups such as the Clinical Oncology Society of Australia (COSA), and The Society of Hospital Pharmacists of Australia (SHPA) who have endorsed the PRECISION-ITS program as well as other key peak bodies.
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Timepoint [4]
429807
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KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
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Secondary outcome [5]
429808
0
Knowledge of pharmacogenomics amongst health practitioners caring for patients with cancer in the Australian community
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Assessment method [5]
429808
0
Knowledge of pharmacogenomics testing and dosing interventions will be assessed by case vignettes and agreement with various knowledge statements in the National KAP healthcare professional surveys developed specifically for this study by the PRECISION-ITS working group. Separate surveys will be developed for adult and paediatric oncology settings. The surveys cover pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability.
Survey development will be informed by systemic literature review and expert elicitation (via priority partnership meetings within multidisciplinary health professionals, academics and consumers), with questions framed to understand determinants of behaviour as informed by the Theoretical Domains Framework. The health practitioner survey is targeted at healthcare professionals working in cancer care (e.g. oncologist, haematologists, pharmacists & nurses). The survey covers pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability. The surveys will be distributed electronically via public campaigns through Australian professional andconsumer representative groups such as the Clinical Oncology Society of Australia (COSA), and The Society of Hospital Pharmacists of Australia (SHPA) who have endorsed the PRECISION-ITS program aswell as other key peak bodies.
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Timepoint [5]
429808
0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
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Secondary outcome [6]
429809
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Attitudes to pharmacogenomics amongst health practitioners caring for patients with cancer in the Australian community.
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Assessment method [6]
429809
0
Attitudes to pharmacogenomics testing and dosing interventions will be assessed by case vignettes and agreement with various knowledge statements in the National KAP healthcare professional surveys developed specifically for this study by the PRECISION-ITS working group. Separate surveys will be developed for adult and paediatric oncology settings. The surveys cover pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability.
Survey development will be informed by systemic literature review and expert elicitation (via priority partnership meetings within multidisciplinary health professionals, academics and consumers), with questions framed to understand determinants of behaviour as informed by the Theoretical Domains Framework. The health practitioner survey is targeted at healthcare professionals working in cancer care (e.g. oncologist, haematologists, pharmacists & nurses). The survey covers pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability. The surveys will be distributed electronically via public campaigns through Australian professional and consumer representative groups such as the Clinical Oncology Society of Australia (COSA), and The Society of Hospital Pharmacists of Australia (SHPA) who have endorsed the PRECISION-ITS program aswell as other key peak bodies.
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Timepoint [6]
429809
0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
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Secondary outcome [7]
429810
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Perceptions of pharmacogenomics amongst health practitioners caring for patients with cancer in the Australian community.
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Assessment method [7]
429810
0
Perceptions of pharmacogenomics testing and dosing interventions will be assessed by case vignettes and agreement with various knowledge statements in the National KAP healthcare professional surveys developed specifically for this study by the PRECISION-ITS working group. Separate surveys will be developed for adult and paediatric oncology settings. The surveys cover pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability.
Survey development will be informed by systemic literature review and expert elicitation (via priority partnership meetings within multidisciplinary health professionals, academics and consumers), with questions framed to understand determinants of behaviour as informed by the Theoretical Domains Framework. The health practitioner survey is targeted at healthcare professionals working in cancer care (e.g. oncologist, haematologists, pharmacists & nurses). The survey covers pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability. The surveys will be distributed electronically via public campaigns through Australian professional and consumer representative groups such as the Clinical Oncology Society of Australia (COSA), and The Society of Hospital Pharmacists of Australia (SHPA) who have endorsed the PRECISION-ITS program aswell as other key peak bodies.
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Timepoint [7]
429810
0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
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Secondary outcome [8]
429811
0
Acceptability of pharmacogenomics amongst health practitioners caring for patients with cancer in the Australian community.
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Assessment method [8]
429811
0
Acceptability of pharmacogenomics testing and dosing interventions will be assessed by case vignettes and agreement with various knowledge statements in the National KAP healthcare professional surveys developed specifically for this study by the PRECISION-ITS working group. Separate surveys will be developed for adult and paediatric oncology settings. The surveys cover pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability.
Survey development will be informed by systemic literature review and expert elicitation (via priority partnership meetings within multidisciplinary health professionals, academics and consumers), with questions framed to understand determinants of behaviour as informed by the Theoretical Domains Framework. The health practitioner survey is targeted at healthcare professionals working in cancer care (e.g. oncologist, haematologists, pharmacists & nurses). The survey covers pharmacogenomics in oncology as a broad topic, with a specific sub-focus in relation to pharmacogenomic education, a pre-identified key determinant of behaviour change from our systematic review of the literature and requirement for program scalability and sustainability. The surveys will be distributed electronically via public campaigns through Australian professional and consumer representative groups such as the Clinical Oncology Society of Australia (COSA), and The Society of Hospital Pharmacists of Australia (SHPA) who have endorsed the PRECISION-ITS program aswell as other key peak bodies.
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Timepoint [8]
429811
0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
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Secondary outcome [9]
431200
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PRIMARY OUTCOME: Evaluation of finalised PGx education program for pharmacists
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Assessment method [9]
431200
0
The finalised PGx education program will be delivered 6 months before commencing Time Series 2 participant accrual in the primary PGx trial. After the program has been launched, the education program will be evaluated by participants through an end-user survey (designed specifically for this study) within 4 weeks after participant program completion. Change in pharmacogenomics knowledge will be measured by pre- and post-knowledge tests (designed specifically for this study), taking place 4 weeks before and after program participation respectively.
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Timepoint [9]
431200
0
Pre-program pharmacogenomics knowledge test to be completed up to 4 weeks before participant starts finalised education program.
Post-program pharmacogenomics knowledge test to be completed up to 4 weeks after participant completes finalised education program.
End-user surveys for final education program to be assessed 4 weeks after last participant completes finalised education program.
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Eligibility
Key inclusion criteria
National KAP Survey - Healthcare professionals (adult oncology)
1. Cancer healthcare professional (medical oncologist, haematologist, pharmacist, or nurse)
2. Cares for people with cancer at an Australian hospital, or managers or clinical supervisors of healthcare professionals who care for people with cancer at an Australian hospital
3. English language reading capability to complete surveys
National KAP Survey - Consumers (adult oncology)
1. Adults, aged > 18 years
2. Have had treatment for cancer, or cared for a person who has had treatment for cancer in the Australian healthcare system
3. English language reading capability to complete surveys
National KAP Survey - Adolescents & Young Adults (AYA) (paediatric oncology)
1. AYA aged > 15 years who have a diagnosis of cancer or immunosuppression
2. Have had treatment for cancer, or cared for a person who has had treatment for cancer in the Australian healthcare system
3. English language reading capability to complete surveys
National KAP Survey - Carers (paediatric oncology)
1. Caregiver of a child who has received a diagnosis of cancer or immunosuppression (current or recent)
2. Caregiver of a child who has had treatment for cancer in the Australian healthcare system
3. English language reading capability to complete surveys
National KAP Survey - Healthcare professionals (paediatric oncology)
1. Cancer healthcare professional (medical oncologist, haematologist, pharmacist, or nurse)
2. Cares for people with cancer at an Australian hospital, or managers or clinical supervisors of healthcare professionals who care for people with cancer at an Australian hospital
3. English language reading capability to complete surveys
Pharmacogenomics Education/Implementation Program:
1. Pharmacists at PRECISION-ITS primary and satellite sites.
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Minimum age
15
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
National KAP Survey - Adolescents & Young Adults (AYA) (paediatric oncology)
1. AYA must not be participating in the MARVEL-PIC study (NCT05667766).
National KAP Survey - Carers (paediatric oncology)
1. Child of caregiver must not be participating in the MARVEL-PIC study (NCT05667766).
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
31/05/2024
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Actual
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Date of last participant enrolment
Anticipated
30/09/2024
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Actual
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Date of last data collection
Anticipated
31/03/2027
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
25845
0
Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [2]
25846
0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
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Recruitment hospital [3]
25847
0
Border Medical Oncology - Albury
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Recruitment hospital [4]
25848
0
Goulburn Valley Health - Shepparton campus - Shepparton
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Recruitment hospital [5]
25849
0
Barwon Health - Geelong Hospital campus - Geelong
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Recruitment hospital [6]
25850
0
South West Healthcare - Warrnambool - Warrnambool
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Recruitment hospital [7]
25852
0
Latrobe Regional Hospital - Traralgon
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Recruitment postcode(s) [1]
41672
0
3000 - Melbourne
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Recruitment postcode(s) [2]
41673
0
3550 - Bendigo
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Recruitment postcode(s) [3]
41674
0
2640 - Albury
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Recruitment postcode(s) [4]
41675
0
3630 - Shepparton
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Recruitment postcode(s) [5]
41676
0
3220 - Geelong
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Recruitment postcode(s) [6]
41677
0
3280 - Warrnambool
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Recruitment postcode(s) [7]
41679
0
3844 - Traralgon
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Funding & Sponsors
Funding source category [1]
315229
0
Government body
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Name [1]
315229
0
Department of Health and Aged care (Medical research future fund)
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Address [1]
315229
0
Department of Health and Aged Care - GPO Box 9848 Canberra ACT 2601
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Country [1]
315229
0
Australia
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Funding source category [2]
315232
0
Hospital
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Name [2]
315232
0
Peter MacCallum Cancer Centre
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Address [2]
315232
0
305 Grattan St Melbourne VIC 3000
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Country [2]
315232
0
Australia
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Primary sponsor type
Hospital
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Name
Peter MacCallum Cancer Centre
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Address
305 Grattan St Melbourne VIC 3000
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Country
Australia
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Secondary sponsor category [1]
317261
0
None
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Name [1]
317261
0
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Address [1]
317261
0
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Country [1]
317261
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314154
0
Peter MacCallum Cancer Centre Human Research Ethics Committee
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Ethics committee address [1]
314154
0
305 Grattan St, Melbourne VIC 3000
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Ethics committee country [1]
314154
0
Australia
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Date submitted for ethics approval [1]
314154
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12/09/2023
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Approval date [1]
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30/10/2023
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Ethics approval number [1]
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HREC/101174/PMCC (23/149)
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Summary
Brief summary
This is a substudy of the PRECISION-ITS trial. This study involves developing and evaluating a pharmacogenomics education/implementation program for pharmacists in Australia, The program will be developed by a multidisciplinary working group consisting of healthcare professionals, consumers and patients/carers with lived experience. Surveys assessing the knowledge, attitudes, perceptions and acceptability of pharmacogenomics amongst consumers and healthcare professionals in the adult and paediatric oncology setting will be used to inform the program's design. Who is it for? .You may be eligible to complete the survey(s) if you have received or cared for an adult or child who received treatment for cancer in Australia and are aged 15 years or above; or are a healthcare professional working in adult or paediatric oncology within Australia. Study details The program will be delivered to pharmacists at sites participating in the primary PRECISION-ITS trial. You may be eligible to participate in the program if you are a pharmacist at a regional Victorian hospital that is participating in the primary PRECISION-ITS trial. The program will focus on pharmacogenomics in adults receiving systemic anticancer therapies and implementing a pharmacogenomics service at participating sites in regional Victoria. The program will be evaluated by implementation science frameworks and participant end-user surveys. It is hoped that this research project will: address pharmacists' education needs in pharmacogenomics and establish a framework for wider implementation to other healthcare professionals and craft groups. It is hoped that this program will also facilitate pharmacogenomics knowledge translation into clinical practice, providing opportunities for rapid pharmacogenomics workforce capacity building, scalability and community acceptance beyond the trial.
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Trial website
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Trial related presentations / publications
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Public notes
This is a substudy of the PRECISION-ITS, multisite, interrupted time series tele-trial, which will run concurrently with the primary PGx study. In the primary PGx study, pharmacogenomics pharmacists at the primary site are responsible for all PGx consenting and follow up in Time Series 1, whereas these activities may be delegated to pharmacists at regional tele-sites in Time Series 2 who have completed the PRECISION-ITS Education/Implementation program.
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Contacts
Principal investigator
Name
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Dr Marliese Alexander
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Address
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Peter MacCallum Cancer Centre - Pharmacy Department, 305 Grattan St, Melbourne VIC 3000
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Country
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Australia
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Phone
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+61385596137
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Safeera Hussainy
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Address
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Peter MacCallum Cancer Centre - Pharmacy Department, 305 Grattan St, Melbourne VIC 3000
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Country
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Australia
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Phone
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+61385595198
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Safeera Hussainy
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Address
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Peter MacCallum Cancer Centre - Pharmacy Department, 305 Grattan St, Melbourne VIC 3000
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Country
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Australia
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Phone
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+61385595198
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Shared data will be limited to the data within the trial dataset approved by the PRECISION-ITS steeringcommittee and sponsor.
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When will data be available (start and end dates)?
Data will be available 2 years after publication of primary results.
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Available to whom?
Researchers whose proposed use of the data has been approved.
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Available for what types of analyses?
Meta analyses
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How or where can data be obtained?
By request to the CPI (
[email protected]
) or co-principal investigator(
[email protected]
) and signed data access agreement.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20928
Study protocol
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20929
Other
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Results publications and other study-related documents
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