The locally recurrent rectal cancer quality of life study

Plain English summary of protocol

Background and study aims
Locally recurrent rectal cancer is cancer that returns close to the origin site following surgery. The extent of the burden that locally recurrent rectal cancer has on quality of life is poorly reported. Patients with advanced cancer value both survival and quality of life. Using only traditional clinical endpoints in advanced cancer settings is no longer valid and should be reported alongside patient-reported outcomes such as quality of life, in an attempt to present a more balanced outlook on treatments and management strategies.

There are many questionnaires that currently exist that are used to assess quality of life, however, these tools have not been validated specifically for patients with locally recurrent rectal cancer. Validation means checking that the questionnaire is applicable across relevant patient groups. The LRRC-QoL is a questionnaire that has been designed specifically to assess quality of life in patients with locally recurrent rectal cancer. The LRRC-QoL has been developed and validated in patients from the UK and Australia.

The aims of the study are:
- to translate and validate the LRRC-QoL into 13 different languages to aid international research in determining the quality of life outcomes in locally recurrent rectal cancer,
- to understand the impact of locally recurrent rectal cancer and its treatment on quality of life,
- to identify survivorship issues relevant to patients who have undergone treatment for locally recurrent rectal cancer and are disease-free,
- to compare the quality of life outcomes between different groups of patients with locally recurrent rectal cancer.

Who can participate?
This study involves participants with locally recurrent rectal cancer.

What does the study involve?
There are three different parts of the study. The first part of the study aims to develop an international questionnaire that can be used to assess the quality of life in patients in patients with locally recurrent rectal cancer. This will involve a translation process followed by interviews with patients to ensure that the questionnaire is acceptable and understandable to them.

The second part of the study aims to measure quality of life in patients with locally recurrent rectal cancer. Quality of life will be assessed using the LRRC-QoL questionnaire at the start of the study, then at 3, 6, and 12 months. Participants will also be asked to complete three additional quality of life questionnaires at the start of the study which will be used in the analysis to ensure that the LRRC-QoL questionnaire is a valid measure of quality of life.

The third part of the study aims to identify the issues which are relevant to and impact upon the quality of life of survivors of locally recurrent rectal cancer. Taking part in this part of the study will involve a one-off interview with a researcher to identify the issues which are relevant to this group of patients.

What are the possible benefits and risks of participating?
The study will deliver wiser benefits as it will provide information regarding quality of life in patients with locally recurrent rectal cancer in many centres internationally. This information can be used to inform shared decision-making between patients and their medical team regarding their care. The study will also allow the LRRC-QoL to be used in future international research. There are no personal benefits to taking part in the study. The study will not affect or alter the treatment participants receive. Participants may find that completing the questionnaires causes them to experience emotional distress in reflecting upon their experience of locally recurrent rectal cancer.

Where is the study run from?
The study is run from the Clinical Trials Research Unit (CTRU) at the University of Leeds in the United Kingdom.

When is the study starting and how long is it expected to run for?
October 2020 to December 2024

Who is funding the study?
The study is funded by Bowel Research UK and Pelican Cancer Foundation (UK)

Who is the main contact?
Dr Niamh McKigney, N.McKigney@leeds.ac.uk

Study website

Contact information

Miss Niamh McKigney
Public

Clinical Trials Research Unit (CTRU)
Level 10, Worsley Building
Clarendon Way
University of Leeds
Leeds
LS2 9NL
United Kingdom

ORCID ID	0000-0003-1599-5701
Phone	+44 1133438089
Email	N.McKigney1@leeds.ac.uk

Miss Niamh McKigney
Scientific

Clinical Trials Research Unit (CTRU)
Level 10, Worsley Building
Clarendon Way
University of Leeds
Leeds
LS2 9NL
United Kingdom

Phone	+44 1133438089
Email	N.McKigney1@leeds.ac.uk

Miss Deena Harji
Principal Investigator

Clinical Trials Research Unit (CTRU)
Level 10, Worsley Building
Clarendon Way
University of Leeds
Leeds
LS2 9NL
United Kingdom

Phone	+44 1133438089
Email	deena.harji@nhs.net

Study information

Eligibility

Locations

Countries of recruitment

• Australia
• Brazil
• Canada
• Denmark
• England
• France
• India
• Ireland
• Italy
• Netherlands
• New Zealand
• Pakistan
• Russian Federation
• Scotland
• Singapore
• Spain
• Sweden
• United Kingdom
• United States of America
• Wales

Study participating centres

Sponsor information

University of Leeds
University/education

Faculty of Medicine and Health Research Office
Room 9.29
Worsley Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom

Phone	+44 1133434897
Email	governance-ethics@leeds.ac.uk
Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Charity

Results and Publications

Study outputs

Editorial Notes

15/01/2025: The intention to publish date was changed from 31/12/2024 to 30/06/2025.
02/12/2022: The following changes were made to the trial record:
1. The overall end date was changed from 01/12/2023 to 02/12/2024.
2. The recruitment end date was changed from 01/12/2022 to 04/12/2023.
3. The plain English summary was updated to reflect these changes.
11/01/2022: The CPMS number was added to the protocol/serial no. field.
20/12/2021: Trial's existence confirmed by West of Scotland Research Ethics Committee 3.