CompletedObservational

The locally recurrent rectal cancer quality of life study

Locally recurrent rectal cancer means cancer has returned in the pelvis near where it first started. While medical treatments are vital, doctors also need to know how these treatments impact your daily wellbeing, emotions, and independence. Researchers have designed a new questionnaire called the LRRC-QoL specifically for people with this type of cancer. This international study wants to make sure the questionnaire works well in several languages and accurately captures what matters most to patients. Depending on your stage of treatment, taking part may involve answering surveys over a 12-month period or completing a one-off interview. You will not have to take any new medications, and your normal NHS care will stay exactly the same. The information gathered will help future patients and healthcare teams make shared, well-informed choices about cancer care.

At a glance

Status

Completed

Sponsor

University of Leeds

Enrolment target

320

Start

05 Nov 2020

Estimated completion

04 Dec 2023

What is this study about?

Rectal cancer is a cancer that starts in the rectum, which is the lower part of the bowel. Sometimes, even after treatment and surgery, the cancer can come back in the same area. Doctors refer to this as 'locally recurrent' rectal cancer. Dealing with a recurrence and going through further treatment can be physically and emotionally challenging, but until recently, little research focused on the day-to-day quality of life for these patients.

Traditionally, cancer studies have mainly measured survival times and tumor sizes. While these are very important, they do not tell the whole story. Everyday issues—such as pain, fatigue, changes to bowel habits, and emotional health—matter just as much to people living with cancer. To measure these factors accurately, researchers in the UK and Australia developed a dedicated questionnaire called the LRRC-QoL.

This study aims to translate and test this questionnaire in 13 languages so it can be used in hospitals worldwide. It also looks at the experiences of long-term survivors who have been cancer-free for several years. By understanding what life is truly like during and after treatment, doctors can offer better symptom support and help future patients choose the treatments that give them the best possible quality of life.

Key takeaways

The study focuses on how locally recurrent rectal cancer affects daily wellbeing and feelings.
It tests a specialised questionnaire called the LRRC-QoL across 13 different languages.
Participation involves completing surveys or taking part in an interview over up to 12 months.
There are no experimental drugs, medical procedures, or changes to your NHS treatment.
Your feedback will help doctors and future patients make better-informed decisions about cancer care.

Who may be eligible?

You may be able to take part if you are 18 or older and have been diagnosed with rectal cancer that has returned in the pelvis near the original site. Because the study looks at different stages of the illness, it is open to people who are newly diagnosed with a recurrence, people who received treatment for a recurrence in the last two years, and people who have been completely cancer-free for more than three years following their recurrence treatment.

You will need to be able to read and write in one of the study's languages and be able to give your written agreement to take part.

This study is not suitable for people whose cancer has spread only to distant parts of the body (like the liver or lungs) without returning to the rectal area. It is also not suitable for people who remain cancer-free following their first rectal cancer treatment, or anyone with memory or thinking difficulties that would make answering detailed surveys difficult.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or over.
I have had rectal cancer that came back in the pelvic area (locally recurrent).
I have either recently been diagnosed, treated within the last 2 years, or been disease-free for over 3 years.
I can read and write in English or another study language.
I feel able to answer questions about my health and wellbeing.

Answer every question to see your result.

What does participation involve?

Taking part in this study does not involve any new drugs, hospital stays, or medical procedures. What you are asked to do depends on which part of the study you join. In one part, you may be asked to review the translated questionnaire in a short interview to ensure it is easy to read and understand. In another part, you will fill out questionnaires about your symptoms and feelings at the start of the study, and then again after 3, 6, and 12 months. If you are a long-term survivor, you may be invited to a single one-off interview with a researcher to talk about your recovery journey. Most questionnaires can be completed at home or during your regular hospital visits, and taking part will not change your routine cancer treatment in any way.

Potential risks and benefits

Taking part will not directly cure or change your cancer, but your answers will help doctors improve care and support for people facing recurrent rectal cancer in the future. There are no physical risks or medication side effects. However, thinking and talking about your cancer experience can sometimes bring up difficult feelings or emotional distress. You do not have to answer any question that makes you uncomfortable, and you are free to leave the study at any time without giving a reason. Leaving the study will never affect the quality of your regular NHS care.

Locations (35)

Manchester Royal Royal Infirmary
City only
Manchester, England
St Marks Hospital
City only
Harrow, England
St James's University Hospital
Approximate
Leeds, England
Morriston Hospital
Approximate
Swansea, Wales
Addenbrookes
Approximate
Cambridge, England
Royal Devon and Exeter Hospital
Unverified
Exeter, England
Glasgow Royal Infirmary
Unverified
Glasgow, Scotland
Leicester Royal Infirmary
Unverified
Leicester, England
Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
Unverified
Nottingham, England
Heartlands Hospital
Unverified
Birmingham, England
The Christie
Unverified
Manchester, England
Oxford Radcliffe Hospital NHS Trust
Unverified
Oxford, England

Common questions

Will taking part change my current cancer treatment?

No. This is an observational quality-of-life study. Your medical team will continue to manage your care and treatment in the exact same way.

Do I have to travel for extra appointments?

Most questionnaires can be completed at home or while you are already at the hospital for your regular appointments. Interviews can often be done over the phone or online.

What kind of questions will I be asked?

You will be asked about your daily activities, physical symptoms like pain or tiredness, bowel and bladder function, and your emotional wellbeing.

What happens if a question upsets me?

You can skip any question you do not wish to answer. If you feel distressed, the study team can point you towards emotional support services or your specialist cancer nurse.

Who is running and funding this research?

The study is organized by the Clinical Trials Research Unit at the University of Leeds and is funded by Bowel Research UK and the Pelican Cancer Foundation.

How to find out more

Niamh McKigney

N.McKigney@leeds.ac.uk +44 1133438089 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.