GI Cancer
Conditions
Keywords
Shared decision making, Radiotherapy, Quality of Life, MRI Staging, MDT Decision Making, Histopathological Staging, Rectal Cancer, Preoperative staging
Brief summary
The cancer stage information from scans guides pre-operative treatment and the type of surgery offered. The investigators are studying whether a new Magnetic Resonance Imaging (MRI) staging method can improve the accuracy of prognosis for patients diagnosed with rectal cancer. The investigators will provide consultant radiologists with the know-how to report MRI scans using this new method and compare this with the existing method. This study will test this by comparing how accurately the old versus new method predict the outcomes of patients. The existing method relies on radiologists determining if tumour has spread through the bowel wall or not and whether there are suspected malignant lymph nodes. The new method looks for tumour spread into the veins and whether or not there are tumour deposits. Our previous research has shown that the new method is much more accurate at predicting prognosis, but this finding needs to be verified by a larger multicentre study. The investigators are also studying the patient journey, so the investigators can better understand patients' experiences and the impact that treatments have on their quality of life. The investigators wish to understand if improvements in the accuracy of prognosis from scans could change treatment decisions in future. The investigators will also compare the radiology scan prediction of prognostic factors by looking carefully at the tumour specimens.
Detailed description
A Retrospective and Prospective Cohort study to improve the prognostic accuracy of preoperative staging in patients diagnosed with primary rectal cancer. The intervention is the training of radiologists to implement specialised MRI reporting using the TDV staging system. The investigators will collect anonymized scans, clinical and histopathology data from all rectal cancer patients diagnosed in 2019. The central reviewing radiologist will stage the scans by a) mrTDV and b) mrTNM into poor and good prognosis categories. The investigators will compare survival outcomes from original reports as well as the two staging systems using Kaplan-Meier and Cox Proportional-Hazard methods. The investigators will compare prospectively collected data before and after implementation of the consensus for identifying and treating high-risk and low-risk rectal cancers. The investigators will report on the comparisons of staging, histopathology, MDT treatment decisions, resource utilisation, how patients experienced information provided for shared decision making before and after the intervention changes and quality of life measures.
Interventions
OTHERmrTDV
The training of radiologists to implement specialised MRI reporting using the TDV staging system
Sponsors
NHS England
Pelican Cancer Foundation
Imperial College London
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The study will proceed through three phases: pre-intervention, intervention, and post-implementation. Pre-intervention - local MDT decisions based on current MRI reporting practices will be collected for six months. Intervention - local radiologists will be trained to recognize features of mrTDV and use a standardised reporting template. We will present the retrospective and radiologists' cohort results to MDT stakeholders who will agree the optimum stage based preoperative treatment decision making policy. We will offer training as required using the 2019 retrospective cohort. Post-intervention - local MDT decisions based on the consensus optimum stage based preoperative decision-making policy will be collected for six months.
Eligibility
Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Have a rectal cancer proven on biopsy or subsequent surgery 2. Sites able to submit anonymised MRI staging scans, pathology and imaging reports for central review 3. Aged 16 years or over
Exclusion criteria
1. Have irresectable metastatic disease at time of initial staging 2. Undergoing palliative treatment for Rectal Cancer 3. Have a biopsy-proven rectal malignancy which is not adenocarcinoma 4. Are contraindicated for MRI staging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validate that mrTDV staging can predict prognosis more accurately than mrTNM. | 1 and 5 years | Survival differences for mrTNM and mrTDV before and after intervention will be compared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare percentage agreement when staging of tumours using mrTDV method of staging rectal cancer and TNM method of staging rectal cancer with respective histopathology staging for prognosis. | 1 and 5 years | Compare agreement in prognostic accuracy between radiology and histopathology using when the TNM system of staging (scoring tumour, nodes and metastases) versus when using TDV system of staging (scoring tumour deposits and extramural venous invasion) is used. |
| Measure the introduction of mrTDV staging and its impact on MDT decision-making with regards to treatment decisions | 1 and 5 years | Comparison of what and how many treatments are offered as MDT policy to patients before and after mrTDV intervention |
| Report changes in numbers of treatments offered following MRI-TDV staging intervention | 6 months and 1 year | Comparison of treatments given before and after mrTDV intervention |
| Report differences in disease free survival outcomes for rectal cancers staged using mrTNM method of staging versus TDV method of staging | 1 and 5 years | Comparison of numbers of patients with disease free survival before and after mrTDV intervention |
| Report differences in local recurrence rates for rectal cancers staged using mrTNM method of staging versus TDV method of staging | 1 and 5 years | Comparison of numbers of patients with local recurrencebefore and after mrTDV intervention |
| Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients before and after adoption of mrTDV staging | 6 months, 1 and 5 years | Comparison of QoL EORTC QLQ-CR29 scores before and after intervention. Questions relate to difficulty in performing every day tasks answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much' |
| Qualitative EORTC QLQ-CR30 Questionnaire on Quality of Life of patients before and after adoption of mrTDV staging | 6 months, 1 and 5 years | Comparison of QoL EORTC QLQ-CR30 scores before and after intervention. Questions relate to the presences of symptoms over the previous week answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much' |
| Assess the degree of agreement between radiologists using mrTDV method of staging rectal cancer vs mrTNM method of staging rectal cancer. | 1 and 5 years | Compare percentage agreement between radiologists when the TNM system of staging (scoring tumour, nodes and metastases) versus when using TDV system of staging (scoring tumour deposits and extramural venous invasion) is used. |
| Report differences in patient shared decision making (SDM) before and after adoption of mrTDV staging | 6 months, 1 and 5 years | Comparison of SM-Q9 scores before and after intervention. Answers are rated from 1 very poor to 7 excellent |
| Validate an educational programme for radiologists and MDTs to improve MRI reporting with TDV staging. | 6 months and 1 year | Percentage agreement of radiologists prognostic accuracy using mrTNM method of staging versus mrTDV method of staging |
| Comparison of inpatient costs between patients before and after intervention | 18 and 36 months | Comparison of relative percentage histopathological biomarkers screening panels between patients identified by the radiologist on the report before and after intervention |
| Comparison of total cost of outpatient visits between patients before and after intervention | 18 and 30 months | Comparison of total cost of outpatient episodes based on individual pathways before and after intervention |
| Number of patients without disease and/or without stoma before and after intervention | 18 and 30 months | DFS and stoma free survival in patients based on individual pathways before and after intervention |
| Assessment of novel and existing histopathological biomarkers to improve prognostic and predictive markers | 6, 12, 18 months and 3, 5 years | Comparison of relative percentage histopathological biomarkers screening panels between patients identified by the radiologist on the report before and after intervention |
| Report differences in patient LARS scores before and after adoption of mrTDV staging | 6 months, 1 and 5 years | Comparison of LARS scores before and after intervention. Questions relate to bowel function answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much' |
Countries
United Kingdom
Contacts
Primary ContactCaroline Martin
Outcome results
None listed