Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A study looking at the first year after diagnosis for people with mouth cancer and their partners
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Head and neck cancers
Mouth (oral) cancer
Status:
Closed
Phase:
Other
This study is looking to improve our understanding of what it means to be diagnosed with and treated for mouth cancer, or have a partner who has been. So far, there is little research in this area. To help improve the way we support people with mouth cancer and their families, we need to find out what people’s needs are and how they change over time. This can be called ‘survivorship’, and relates to things such as people’s 
, support networks and physical and mental wellbeing.
Researchers in this study will talk to people with mouth cancer, as well as partners of people living with this condition. They will also gather information from questionnaires, and diaries of people’s experiences since diagnosis. The aim of this study is to better understand what it means to be diagnosed with and treated for mouth cancer, or to have a partner who has been.
Who can enter
Please note - You cannot volunteer to take part in this study. If you are suitable to join, the person running this study will ask if you would like to take part. This study is divided into 2 parts – the pilot study and the main study.
The pilot study is a small scale version of the main study.
People may be able to enter either part of this study if they
- Have recently been diagnosed with mouth cancer
- Are about to start treatment for mouth cancer, to cure it rather than to control symptoms
- Are at least 18 years of age
People cannot enter the study if they have had treatment for cancer, but it has come back.
If you take part in the main study, you will also need to join another study called Head and Neck 5000, which this one is linked to. You would not be able to join Head and Neck 5000 if
- Your head and neck cancer is a type of lymphoma
- Your cancer did not start in your head or neck
- You have had treatment for your head and neck cancer, but it has come back
The team will also recruit the partners of some of those taking part for both the pilot and the main study. Partners taking part need to be over 18.
Trial design
The pilot part of the study will recruit 4 people with mouth cancer, and 2 partners. If a person takes part in the pilot study, as either a patient or a partner, a member of the research team will interview them about their experiences before and after the diagnosis. With permission, they will tape record the interview so that they can write everything down later to study.
The team will use this interview to look at topics covered, and to work out the best way to ask questions for the main study interviews. Couples taking part can choose whether they would like to be interviewed together or on their own.
The main study will recruit 15 people with mouth cancer, and 8 partners. People taking part in the main study also need to take part in Head and Neck 5000.
People taking part have 3 interviews as part of the study. They may also keep a diary of any experiences or feelings they have about their cancer and treatment over the first 9 months of the study. And, continue to complete the questionnaires as part of the Head and Neck 5000 study.
The team will ask permission to look at some of their Head and Neck 5000 questionnaires. They would like to use the interviews to ask more about some of the questionnaire answers and diary entries.
If you are a partner taking part, you will also have 3 interviews and keep a diary, to tell the study team your experiences or feelings about your partner’s cancer and treatment. But you will not take part in Head and Neck 5000.
Hospital visits
People taking part in the pilot study will have their interview at some point before starting treatment, either at hospital or at home.
People taking part in the main study will have their interviews
- Before starting cancer treatment
- 4 months after the first interview
- 12 months after the first interview
Each interview will take about an hour and a half and will take place either at the hospital or at home.
Side effects
There are no expected side effects from this study. But if people feel any distress as a result of taking part the team will help them to get further support.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Miss Holly Cole-Hawkins
Supported by
National Institute for Health Research (Training Fellowship)
National Institute for Health Research Cancer Research Network (NCRN)
University Hospitals Bristol NHS Foundation Trust
University of Bristol
Freephone 0808 800 4040
Last review date
CRUK internal database number:
Oracle 7658
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Around 1 in 5 people take part in clinical trials
