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Trial registered on ANZCTR


Registration number
ACTRN12618001072202
Ethics application status
Approved
Date submitted
15/06/2018
Date registered
27/06/2018
Date last updated
13/06/2019
Date data sharing statement initially provided
13/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Hide and Seek with Hereditary Cancer: Improving detection of colorectal cancer patients with a high risk of Lynch syndrome
Scientific title
Comparing theory and non-theory based implementation approaches to improving referral practices in cancer genetics: a randomised controlled trial
Secondary ID [1] 295209 0
None
Universal Trial Number (UTN)
Trial acronym
HaSP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lynch syndrome 308349 0
Colorectal cancer 308386 0
Condition category
Condition code
Human Genetics and Inherited Disorders 307458 307458 0 0
Other human genetics and inherited disorders
Cancer 307349 307349 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A two-arm parallel randomised control trial (RCT) will be used to test a theory based implementation approach (Theoretical Domains Framework Implementation) against a non-theory based implementation approach to improving identification of Lynch syndrome amongst colorectal cancer patients.
At each hospital, a locally employed healthcare professional will be appointed as a paid ‘Implementation Lead’ (IL) at one day per week over a 24-month period to coordinate the implementation approach and to oversee data collection. They will have a professional understanding of the LS patient pathway, and the ability to motivate other LS stakeholders to engage with implementation processes. Each Implementation Lead will participate in a 1-day training seminar by a health psychologist from the CCNSW research team in one of two approaches (theory or non-theory). CIA Taylor developed the following training toolkit and 1-day course: http://www.improvementacademy.org/tools-and-resources/abc-for-patient-safety-toolkit.html. These training materials have been refined for this study and modified according to trial arm. Those in the theory-based trial arm will be trained in the Theoretical Domains Framework Implementation (TDFI) approach. Following training, the Implementation Lead will work through the following steps at their hospital over a 24-month period:
1. Extract baseline audit data: Clinical data from surgical, pathology and FCC databases will be extracted to determine proportion of pts appropriately referred
2. Form Implementation Team: will form a team of 8-10 multidisciplinary staff involved in the LS referral and diagnosis pathway (e.g. genetic counsellors, CRC surgeons, oncologists, pathologists, nurses, admin etc)
3. Map referral process and identify targets for change: 2 x meetings to map current processes and (using audit data) identify areas for change
4. Identify barriers to change: Staff to complete 5 min questionnaire about perceived barriers & focus group to discuss and confirm main barriers (using the theoretical domains framework; TDF)
5. Generate intervention strategies: Second focus group to develop intervention strategies to address main barriers (using the theoretical domains framework; TDF)
6. Implement intervention strategies: Implementation lead (with support from CCNSW) will implement strategies over a 6mo period
7. Evaluate intervention: extract data & compare with baseline to assess change
Intervention code [1] 301546 0
Behaviour
Comparator / control treatment
The comparator is a non-theory based implementation approach which is distinguished only by the lack of theory used to identify barriers and to design targeted interventions, on improving clinical practice for identifying LS patients.
At each hospital, a locally employed healthcare professional will be appointed as a paid ‘Implementation Lead’ (IL) at one day per week over a 24-month period to coordinate the implementation approach and to oversee data collection. They will have a professional understanding of the LS patient pathway, and the ability to motivate other LS stakeholders to engage with implementation processes. Each Implementation Lead will be trained by a member of the CCNSW research team in one of two approaches (theory or non-theory). CIA Taylor developed the following training toolkit and 1-day course: http://www.improvementacademy.org/tools-and-resources/abc-for-patient-safety-toolkit.html. These training materials have been refined for this study and modified according to trial arm. Implementation Leads in the non-theory arm will be trained about general (non-TDF) implementation science principles. Following training, the Implementation Lead will work through the following steps at their hospital over a 24-month period:
1. Extract baseline audit data: Clinical data from surgical, pathology and FCC databases will be extracted to determine proportion of pts appropriately referred
2. Form Implementation Team: will form a team of 8-10 multidisciplinary staff involved in the LS referral and diagnosis pathway (e.g. genetic counsellors, CRC surgeons, oncologists, pathologists, nurses, admin etc)
3. Map referral process and identify targets for change: 2 x meetings to map current processes and (using audit data) identify areas for change
4. Identify barriers to change: Staff to complete 5 min questionnaire about perceived barriers & focus group to discuss and confirm main barriers
5. Generate intervention strategies: Second focus group to develop intervention strategies to address main barriers
6. Implement intervention strategies: Implementation lead (with support from CCNSW) will implement strategies over a 6mo period
7. Evaluate intervention: extract data & compare with baseline to assess change
In contrast to the theory-based trial arm, Phase 4 and 5 will not use the TDF. Barriers and solutions will instead be generated based on intuitition and tacit knowledge.

The trial is targeting the behaviour of health professionals (e.g. surgeons, oncologists, pathologists) to improve referral of patients at high risk of Lynch syndrome. For both implementation trial arms, a historical control (e.g. patients who underwent colorectal cancer resection prior to commencing trial activities) will enable assessment of referral rates before and after the trial period. Patients included in the historical control analyses will be those aged 18 years and older who underwent resection of a CRC tumour between 01/07/2016 -30/06/2018 at participating hospitals. Patient data will be extracted from relevant surgical, pathology, and FCC databases.
Control group
Active

Outcomes
Primary outcome [1] 306306 0
The primary outcome will be the proportion of patients with risk-appropriate completion of the LS referral pathway. Clinical and referral data will be extracted from a number of sources (e.g. hospital, pathology and genetics databases) to assess whether patients at high-risk of Lynch syndrome (e.g. those mismatch repair deficient or high level microsatellite instability colorectal cancer tumours) were referred to a familial cancer clinic for consideration of germline Lynch syndrome testing.
Timepoint [1] 306306 0
Completion of the LS referral pathway within 2 months of CRC resection.
Secondary outcome [1] 348135 0
Proportion of patients with missing testing and referral data (composite secondary outcomes)
Timepoint [1] 348135 0
Within 2 months of CRC resection
Secondary outcome [2] 348134 0
Proportion of referred patients who attended FCC. This will be assessed via extraction of attendance records from the familial cancer clinic database
Timepoint [2] 348134 0
Within 2 months of CRC resection
Secondary outcome [3] 348133 0
Proportion of high risk-patients who were referred to the familial cancer clinics (FCCs) (sensitivity of referral). This will be assessed via linkage of clinical and referral data from a number of sources (e.g. hospital, pathology and genetics databases).
Timepoint [3] 348133 0
Within 2 months of CRC resection

Eligibility
Key inclusion criteria
Australian hospitals routinely conducting surgical CRC resections to patients aged 18 years and over.
Patients included in the analyses will be those aged 18 years and older who underwent resection of a CRC tumour between 01/07/2016 -30/06/2018 at participating hospitals. The trial is targeting the behaviour of health professionals (e.g. surgeons, oncologists, pathologists) to improve referral of patients at high risk of Lynch syndrome. Retrospective audit of patient data from (01/07/2016 -30/06/2018) will enable assessment of referral rates before and after the trial period.
Prospective data will also be collected prospectively to assess for changes in Lynch syndrome referral practices as a result of the implementation intervention, At completion of the trial, data will be extracted for all patients aged 18 years and older who underwent resection of a CRC tumour between 01/07/2018 -30/06/2020.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Australian hospitals who do not routinely conduct surgical CRC resections to patients aged 18 years and over

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each hospital network will be allocated to the theory arm or non-theory arm by central randomisation using a random computer-generated sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random computer-generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Patients will be assigned to the baseline or the post-intervention implementation phase if they underwent surgery before or after the intervention implementation in the CRC patient referral centre, respectively. Patients will be assigned to the theory based or non-theory based implementation arms based on the assignment of the CRC patient referral centre where they underwent surgery. For each dichotomous study outcome, we will estimate the adjusted relative proportion of patients with the outcome using a generalised linear regression model with Poisson distribution, log link and generalised estimating equation (GEE) adjustment for the clustering of patients within hospitals. Covariates will be specified as time period (3-month intervals), time since intervention (3-month intervals), patient age at operation, cancer stage, and private patient status. The Quasi-AIC will be used to select which covariates to include in the final model. To account for non-independence of within-hospital outcomes, all GEE analyses will be carried out with exchangeable working correlation structures and with robust standard errors. We will carry out sensitivity leave-one-out analyses by individually excluding hospitals that accounted for more than 20% of the total patient numbers.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
29/06/2018
Date of last participant enrolment
Anticipated
1/08/2018
Actual
29/06/2018
Date of last data collection
Anticipated
30/08/2021
Actual
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 11136 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 11142 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 11139 0
John Hunter Hospital - New Lambton
Recruitment hospital [4] 11140 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [5] 11141 0
Monash Surgical Private Hospital - Clayton
Recruitment hospital [6] 11137 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [7] 11143 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [8] 13982 0
St John of God Midland Public Hospital - Midland
Recruitment hospital [9] 11138 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 22961 0
2050 - Camperdown
Recruitment postcode(s) [2] 22962 0
2145 - Westmead
Recruitment postcode(s) [3] 22963 0
2305 - New Lambton
Recruitment postcode(s) [4] 22966 0
6150 - Murdoch
Recruitment postcode(s) [5] 22964 0
3050 - Parkville
Recruitment postcode(s) [6] 22960 0
2065 - St Leonards
Recruitment postcode(s) [7] 22965 0
3168 - Clayton
Recruitment postcode(s) [8] 26759 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 299795 0
Government body
Name [1] 299795 0
Cancer Australia
Country [1] 299795 0
Australia
Funding source category [2] 299794 0
Government body
Name [2] 299794 0
Cancer Institute NSW
Country [2] 299794 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council NSW
Address
153 Dowling St, Woolloomooloo, NSW 2011
Country
Australia
Secondary sponsor category [1] 299143 0
None
Name [1] 299143 0
N/A
Address [1] 299143 0
N/A
Country [1] 299143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300680 0
Royal Prince Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 300680 0
Ethics committee country [1] 300680 0
Date submitted for ethics approval [1] 300680 0
28/09/2017
Approval date [1] 300680 0
22/12/2017
Ethics approval number [1] 300680 0
HREC/17/RPAH/542

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84450 0
Dr Natalie Taylor
Address 84450 0
Cancer Research Division
Cancer Council NSW
153 Dowling St, Woolloomooloo, NSW 2011
Country 84450 0
Australia
Phone 84450 0
+61(2) 9334 1974
Fax 84450 0
Email 84450 0
natalie.taylor@nswcc.org.au
Contact person for public queries
Name 84451 0
April Morrow
Address 84451 0
Cancer Research Division
Cancer Council NSW
153 Dowling St, Woolloomooloo, NSW 2011
Country 84451 0
Australia
Phone 84451 0
+61(2) 9334 1974
Fax 84451 0
Email 84451 0
natalie.taylor@nswcc.org.au
Contact person for scientific queries
Name 84452 0
Natalie Taylor
Address 84452 0
Cancer Research Division
Cancer Council NSW
153 Dowling St, Woolloomooloo, NSW 2011
Country 84452 0
Australia
Phone 84452 0
+61(2) 9334 1974
Fax 84452 0
Email 84452 0
natalie.taylor@nswcc.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD contains sensitive clinical information that is not suitable for sharing. Ethics approval has been obtained only for the sharing of aggregate de-identified patient data


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
SourceTitleYear of PublicationDOI
EmbaseComparing theory and non-theory based implementation approaches to improving referral practices in cancer genetics: A cluster randomised trial protocol.2019https://dx.doi.org/10.1186/s13063-019-3457-6
EmbaseUnderstanding implementation success: Protocol for an in-depth, mixed-methods process evaluation of a cluster randomised controlled trial testing methods to improve detection of Lynch syndrome in Australian hospitals.2020https://dx.doi.org/10.1136/bmjopen-2019-033552
EmbaseBuilding capacity from within: Qualitative evaluation of a training program aimed at upskilling healthcare workers in delivering an evidence-based implementation approach.2022https://dx.doi.org/10.1093/tbm/ibab094
N.B. These documents automatically identified may not have been verified by the study sponsor.