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
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
Secondary ID [1] 310971 0
MRFMMIP000011
Universal Trial Number (UTN)
Trial acronym
PRECISION-ITS
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

Health condition
Health condition(s) or problem(s) studied:
Cancer and other malignant neoplasms 332057 0
Condition category
Condition code
Cancer 328780 328780 0 0
Any cancer
Public Health 329032 329032 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 327402 0
Behaviour
Comparator / control treatment
Not applicable, there is no control group for this substudy.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336591 0
Evaluation of initial pharmacogenomics education program for pharmacists.
Timepoint [1] 336591 0
User testing for initial program to occur at Month 10.
SUS assessments/user testing for initial program to be completed at Month 11.
Primary outcome [2] 336593 0
Evaluation of PRECISION-ITS pharmacist program implementation, according to the Consolidated Framework for Implementation Research (CFIR).
Timepoint [2] 336593 0
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.
Primary outcome [3] 336841 0
Evaluation of PRECISION-ITS pharmacist program implementation, according to the Reach, Efficacy, Adoption, Implementation and Maintenance (RE-AIM) framework.
Timepoint [3] 336841 0
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.
Secondary outcome [1] 428909 0
Knowledge of pharmacogenomics amongst consumers/carers in the Australian community.
Timepoint [1] 428909 0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
Secondary outcome [2] 429805 0
Attitudes to pharmacogenomics amongst consumers/carers in the Australian community.
Timepoint [2] 429805 0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
Secondary outcome [3] 429806 0
Perceptions to pharmacogenomics amongst consumers/carers in the Australian community.
Timepoint [3] 429806 0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
Secondary outcome [4] 429807 0
Acceptability of pharmacogenomics amongst consumers/carers in the Australian community.
Timepoint [4] 429807 0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
Secondary outcome [5] 429808 0
Knowledge of pharmacogenomics amongst health practitioners caring for patients with cancer in the Australian community
Timepoint [5] 429808 0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
Secondary outcome [6] 429809 0
Attitudes to pharmacogenomics amongst health practitioners caring for patients with cancer in the Australian community.
Timepoint [6] 429809 0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
Secondary outcome [7] 429810 0
Perceptions of pharmacogenomics amongst health practitioners caring for patients with cancer in the Australian community.
Timepoint [7] 429810 0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
Secondary outcome [8] 429811 0
Acceptability of pharmacogenomics amongst health practitioners caring for patients with cancer in the Australian community.
Timepoint [8] 429811 0
KAP surveys to be distributed at Month 6
All KAP surveys to be completed/evaluated at Month 9
Secondary outcome [9] 431200 0
PRIMARY OUTCOME: Evaluation of finalised PGx education program for pharmacists
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.

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.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25845 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 25846 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [3] 25847 0
Border Medical Oncology - Albury
Recruitment hospital [4] 25848 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment hospital [5] 25849 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [6] 25850 0
South West Healthcare - Warrnambool - Warrnambool
Recruitment hospital [7] 25852 0
Latrobe Regional Hospital - Traralgon
Recruitment postcode(s) [1] 41674 0
2640 - Albury
Recruitment postcode(s) [2] 41672 0
3000 - Melbourne
Recruitment postcode(s) [3] 41676 0
3220 - Geelong
Recruitment postcode(s) [4] 41677 0
3280 - Warrnambool
Recruitment postcode(s) [5] 41673 0
3550 - Bendigo
Recruitment postcode(s) [6] 41675 0
3630 - Shepparton
Recruitment postcode(s) [7] 41679 0
3844 - Traralgon

Funding & Sponsors
Funding source category [1] 315229 0
Government body
Name [1] 315229 0
Department of Health and Aged care (Medical research future fund)
Country [1] 315229 0
Australia
Funding source category [2] 315232 0
Hospital
Name [2] 315232 0
Peter MacCallum Cancer Centre
Country [2] 315232 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan St Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 317261 0
None
Name [1] 317261 0
Address [1] 317261 0
Country [1] 317261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314154 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 314154 0
305 Grattan St, Melbourne VIC 3000
Ethics committee country [1] 314154 0
Australia
Date submitted for ethics approval [1] 314154 0
12/09/2023
Approval date [1] 314154 0
30/10/2023
Ethics approval number [1] 314154 0
HREC/101174/PMCC (23/149)

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.
Trial website
Trial related presentations / publications
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.

Contacts
Principal investigator
Name 130606 0
Dr Marliese Alexander
Address 130606 0
Peter MacCallum Cancer Centre - Pharmacy Department, 305 Grattan St, Melbourne VIC 3000
Country 130606 0
Australia
Phone 130606 0
+61385596137
Fax 130606 0
Email 130606 0
marliese.alexander@petermac.org
Contact person for public queries
Name 130607 0
A/Prof Safeera Hussainy
Address 130607 0
Peter MacCallum Cancer Centre - Pharmacy Department, 305 Grattan St, Melbourne VIC 3000
Country 130607 0
Australia
Phone 130607 0
+61385595198
Fax 130607 0
Email 130607 0
safeera.hussainy@petermac.org
Contact person for scientific queries
Name 130608 0
A/Prof Safeera Hussainy
Address 130608 0
Peter MacCallum Cancer Centre - Pharmacy Department, 305 Grattan St, Melbourne VIC 3000
Country 130608 0
Australia
Phone 130608 0
+61385595198
Fax 130608 0
Email 130608 0
pharmacogenetics.pharmacist@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
Data will be available 2 years after publication of primary results.
Available to whom?
Researchers whose proposed use of the data has been approved.
Available for what types of analyses?
Meta analyses
How or where can data be obtained?
By request to the CPI (marliese.alexander@petermac.org) or co-principal investigator(senthil.lingaratnam@petermac.org) and signed data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20928Study protocol  marliese.alexander@petermac.org Study protocol will be provided to approved applic... [More Details]
20929Other  marliese.alexander@petermac.org Surveys will be provided to approved applicants by... [More Details]



Results publications and other study-related documents

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