Plain English Summary
Background and study aims
In the UK, there are over 16,000 new cases of rectal cancer per year. Treatment includes chemotherapy and radiotherapy, followed by major surgery, especially in those patients deemed as ‘high-risk’. There are risks of surgical complications, long-term side-effects, and about a third of patients require a permanent colostomy (a ‘bag’).
In the past 5-8 years, researchers have found that rectal tumours may totally disappear after chemo-radiotherapy in 25% patients (known as a clinical complete response), avoiding the need for surgery. This is a new type of rectal cancer management known as ‘organ preservation’. Instead of surgery, patients are actively monitored, ‘watch-and-wait’, to ensure tumours have not returned.
Initially, doctors were nervous that not giving patients surgery might compromise long-term survival. However, one of the largest studies in the world addressing this question and based in NW England (the OnCoRe project; lead: Renehan), showed that this approach is safe. There is a common perception among cancer doctors that organ preservation is a good thing, but there is little research addressing patient preferences. Specifically, no research has investigated how people balance the characteristics of these treatments and make decisions.
There are no decision aids for this complex treatment; yet it is known that decision aids have a positive effect on patient-clinician communication and enhance quality of patient decision-making.
Study aims:
1. To understand the factors taken into account by patients when making a decision on rectal cancer treatments
2. To develop an electronic patient decision aid based on these factors, which will be able to directly benefit patients facing this decision within the next few years.
Who can participate?
The online survey will be open to both people with a previous diagnosis of rectal cancer and members of the general public.
What does the study involve?
The completion of a survey which is expected to take around 20 minutes. In this survey, participants will first be shown information on different types of treatment options available for rectal cancer. Participants will then be asked some questions about their preferences for the treatment of rectal cancer. Following this, there will be some questions about how health information is used to make decisions and participants views about treating rectal cancer. Finally, optional questions will be asked regarding the participant.
What are the possible benefits and risks of participating?
There is a small risk that participants may find reading about cancer distressing. Links to further information about rectal cancer will be included in the survey. There are no direct benefits to participants for participating in the study, but we hope to use the information gathered from this study to improve the care received by rectal cancer patients within the National Health Service (NHS).
Where is the study run from?
The study is being run from The University of Manchester (UK)
When is the study starting and how long is it expected to run for?
March 2020 to March 2022
Who is funding the study?
National Institute for Health Research (NIHR)
Who is the main contact?
Mr Lee Malcomson, lee.malcomson@manchester.ac.uk
Prof. Andrew Renehan, andrew.renehan@manchester.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Andrew Renehan
ORCID ID
http://orcid.org/0000-0003-4309-4396
Contact details
Oglesby Cancer Research Building
555 Wilmslow Rd
Manchester
M20 4GJ
United Kingdom
+44 (0)161 3060870
andrew.renehan@manchester.ac.uk
Type
Public
Additional contact
Mr Lee Malcomson
ORCID ID
http://orcid.org/0000-0002-8237-5329
Contact details
Oglesby Cancer Research Building
555 Wilmslow Rd
Manchester
M20 4GJ
United Kingdom
+44 (0)1614468417
lee.malcomson@manchester.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
NIHR200500
Study information
Scientific title
Quantifying and implementing patient preferences for the treatment of high-risk rectal cancer, including the new strategy of organ preservation: The PrefCoRe Study
Acronym
PrefCoRe
Study hypothesis
This study is taking place to investigate and understand factors taken into account by patients (current & future) when making a key decision on rectal cancer treatment. Specifically, patients who have a complete clinical response to (chemo)radiotherapy and have the choice of either major resection surgery or a watch & wait (active surveillance) pathway. In addition, we aim to develop an user-friendly patient decision aid informed by these factors and conduct preliminary tests of the tool to understand its acceptability.
Ethics approval
Approval pending. The application is currently in progress and is to be submitted for review by the University of Manchester Ethics Board by 09/10/2020
Study design
Observational
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Internet
Trial type
Quality of life
Patient information sheet
https://completeresponse.files.wordpress.com/2020/10/full-pis-prefcore_bowel-cancer-uk-2.docx
Condition
Rectal cancer
Intervention
An online survey comprising a discrete choice experiment (DCE) will be designed to elicit preferences of a sample of patients and members of the public for the treatment of high-risk rectal cancer. The DCE will ask respondents to choose between three labelled alternatives: watch-and-wait, surgery and wait-and-see (no surgery or follow-up visits). The experimental design of the DCE will be informed using Ngene. The online survey will consist of a consent form, followed by an animated narrative storyline (that will be produced in collaboration with SciAni), the choice sets, questions about respondents’ personal views on decision-making in healthcare, questions regarding their attitude towards risk, their current health status, socio-demographic questions about themselves and questions to gauge their understanding of probabilities.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Participant treatment preference recorded during the DCE at a single timepoint
Secondary outcome measures
Usability score recorded for the designed Dynamic Computer Interactive Decision Application (DCIDA) measured using the System Usability Scale (SUS) at a single timepoint immediately after the intervention
Overall trial start date
02/03/2020
Overall trial end date
01/03/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18+
2. Previous diagnosis of rectal cancer (for ~50% of participants)
3. Able to complete and submit an online DCE
Participant type
All
Age group
Adult
Gender
Both
Target number of participants
600
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
04/11/2020
Recruitment end date
31/12/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The University of Manchester
Oxford Rd
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester
Sponsor details
Oxford Rd
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 6000
FBMHethics@manchester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (RfPB Award, ref NIHR200500)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
In addition to the published Dynamic Computer Interactive Decision Application (DCIDA), we are aiming for publication in high-impact, peer-reviewed journals once the results are available.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
01/03/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list