Condition category
Cancer
Date applied
02/10/2020
Date assigned
30/10/2020
Last edited
19/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://complete-response.com/prefcore/

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

http://www.manchester.ac.uk/

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

Publication citations

Additional files

Editorial Notes

02/10/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)