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Hide and Seek with Hereditary Cancer: Improving detection of colorectal cancer patients with a high risk of Lynch syndrome

Comparing theory and non-theory based implementation approaches to improving referral practices in cancer genetics: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001072202
Acronym
HaSP
Enrollment
8
Registered
2018-06-27
Start date
2018-06-29
Completion date
2018-06-29
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to test two different implementation approaches (theory based and non-theory based) in achieving behaviour change amongst healthcare professionals to improve identification of Lynch syndrome amongst colorectal cancer patients. Who is it for? You may be eligible for this study if you are a healthcare professional involved in the Lynch syndrome referral pathway. Although we will be assessing the proportion of colorectal cancer patients appropriately referred for Lynch syndrome genetic testing (based on high-risk LS tumour screening results, e.g. mismatch repair deificiency, or microsatellite instability), we will be targeting the behaviours of health professionals in this study to improve referral practices. Study details Participants will take part in one of two arms (theory based or non-theory based) depending on the hospital in which they work. Participants will be asked to complete questionnaires and will be involved in a series of meetings and focus-groups to map the referral pathway, identify target behaviours for change, identify barriers to behaviour change and develop intervention strategies to address those barriers. Clinical and referral data will be collected before and after the study period to assess for changes in the proportion of patients appropriately referred for Lynch syndrome genetic testing. It is hoped that this research will increase the number of colorectal cancer patients with a high risk of Lynch syndrome who are appropriately referred for genetic counselling and testing.

Interventions

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 o

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

Sponsors

Cancer Council NSW
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Australian hospitals who do not routinely conduct surgical CRC resections to patients aged 18 years and over

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 2, 2026