A study looking at two rehabilitation programmes for people with cancer (PRO-REHAB)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This is a study to develop and test two rehabilitation programmes for people with cancer.
More about this trial
Cancer and its treatment may cause physical, social, emotional or psychological difficulties. But the impact that cancer has on a person varies. The term
Research into rehabilitation programmes for heart disease has shown that offering different forms of rehabilitation helps more people, as this is more likely to meet their individual needs.
Researchers have developed two different cancer rehabilitation programmes. One is an individual home based programme. The other is a group based programme.
The study team need people with
- breast cancer
- bowel cancer
- lung cancer
- prostate cancer
- head and neck cancer
to help them test the programmes in a pilot study, before a large trial to see if cancer rehabilitation improves peoples’ health and wellbeing.
Who can enter
You may be able to join this study if all of these apply. You
- Have breast cancer, bowel cancer, lung cancer, prostate cancer or head and neck cancer
- Finished your initial treatment such as surgery, chemotherapy or radiotherapy in the last year
- Are at least 18 years old
- Have had treatment at University Hospital Coventry and Warwickshire, Warwick Hospital or George Eliot Hospital
You cannot join this study if you have (or have had) a serious mental health problem.
Trial design
The researchers need 150 people to join the pilot study. This part of the study is randomised. The people taking part are put into treatment groups at random. Neither you nor the study team will be able to decide which group you are in.
- 50 people will have the individual home based programme
- 50 people will have the group based programme
- 50 people will have usual care (the
control group )
If you have the group based programme, you go to group meetings once or twice a week for 8 to 12 weeks. The sessions are run by a range of healthcare professionals. At the first session, they will do some baseline tests and discuss what your needs are. They will give you some advice about things that can help people to cope with stress and improve their health and wellbeing. This will take up to an hour.
The team will offer you a range of things that may help with rehabilitation including a tailored exercise programme and ways to reduce anxiety and depression. They will advise you to wear comfortable clothing and flat shoes for the sessions.
If you have the home based programme, a healthcare professional will visit you at home. Or, if you prefer, you can see them at another venue that suits you. They will do some baseline tests and discuss your needs and concerns. Where possible, they will set goals with you to address these. They will design a tailored exercise programme for you. They will also give you a rehabilitation guide book to support you through the programme and relaxation CD.
After the first meeting, you will have further face to face appointments or phone calls to see how you are getting on. The number of meetings and phone calls you have will be decided between you. They will continue for 12 weeks.
If you are in the control group, you will have usual care. This means you will continue to see your specialist doctors, nurses and GP as usual. The study team will also invite you to take part in a focus group to talk about the care you receive.
Whichever group you are in, the study team will ask you to attend 2 follow up appointments, at 3 months and at 6 months. You will complete a short fitness assessment at the rehabilitation centre.This is the same as 1 you do at the start of the study. You also complete some questionnaires either following your assessment or if you would prefer at home.
The study team will ask some people to have interviews or attend focus groups. In these, people will be asked what they think of the care they have received and how it could be changed.
They will make audio recordings of the interviews and meetings, but everything that is discussed is
The researchers will use the feedback from the focus groups to improve the programmes. They will also send details of the programmes to a number of health care professionals for their comments.
When the pilot study is finished, the researchers will test the programmes in a trial to see if they improve peoples’ health and wellbeing.
Hospital visits
Everybody will see a member of the study team and have some tests when they join the pilot study. These include
- A test to see how far you can walk
- Blood pressure check
- Checking the level of sugar in your blood by pricking your finger
- Height, weight and
body mass index (BMI) measurements
The study team will do the same tests again after 3 months and 6 months.
If you have the group based programme, you will go to sessions over 8 to 12 weeks.
If you have the home based programme, a healthcare professional will visit you at home, or you can see them at another venue if you prefer. They will also phone you a number of times over 12 weeks.
The length of time that a focus group discussion takes will depend on how much people have to say, but it is likely to last about an hour. The study team will pay for your travel and parking costs.
If you can’t go to the focus group, they will phone you to get your feedback about the programme.
Side effects
The study team don’t expect there to be any side effects from taking part in this study.
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.
Chief Investigator
Professor Annie Young
Supported by
Coventry University
George Eliot Hospital
NIHR Clinical Research Network: Cancer
NIHR Research for Patient Benefit (RfPB) Programme
University Hospitals Coventry and Warwickshire
University of Warwick
Warwick Hospital
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040