“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A study to create an assessment for possible sexual difficulties in women after radiotherapy for cancers of the womb or cervix
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
We know from research that women and health professionals still find their sexual health challenging to talk about and manage after cancer treatment. Although this is a private and sensitive subject, it is important for health professionals to make sure they are giving enough information and support in this area during and after cancer treatment.
The study team will use the information they collect to design a questionnaire about sexual recovery for women to complete on a laptop while waiting to see their doctor. This assessment can be used by patients and health professionals as part of the routine follow up appointments. The study will run in 3 parts. Parts 1 and 2 will design and test the assessment. Part 3 will be a pilot study to try out the assessment on a small group of women and health professionals. It will also train health professionals to use the assessment. And test if the new questionnaire, and guidance for professionals, improves support and information given to women after treatment.
The aim of this study is to help health professionals to improve assessment of possible sexual and relationship consequences of pelvic radiotherapy for gynaecological cancer. You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will be used to help women with cancer in the future.
Who can enter
You may be able to enter this study if you
- Have cancer of the cervix or cancer of the womb (endometrial cancer)
- Have had radiotherapy aimed to cure your cancer (radical radiotherapy), with or without internal radiotherapy (brachytherapy) or chemotherapy or you have had surgery aimed to cure your cancer between 3 months and 5 years ago
- Are due to have hospital check ups between 3 months and 5 years after your treatment
You cannot enter this study if
- You are having radiotherapy to the area between your hips (pelvic radiotherapy) to control symptoms rather than cure your cancer
- Your treatment did not get rid of all of your cancer, or your cancer is now getting worse
- The staff caring for you think that you are not physically or emotionally well enough to take part
- You cannot easily have a conversation in English
The team will also recruit health professionals with current experience of caring for women after radiotherapy for cervical or womb cancer.
This study is in 3 parts. In part 1, the study team observed radiotherapy clinics. They also interviewed health professionals involved in radiotherapy care, and spoke to 24 women patients who have had radiotherapy to the area between their hips (pelvic radiotherapy). Part 1 of this study has now finished.
The team have used the information they collected in part 1 to design an assessment questionnaire to help women and health care professionals address any sexual difficulties brought about by radiotherapy or surgery to the pelvis. Part 2 of the study will test this questionnaire. It will recruit 220 women.
The first 20 women taking part in part 2 have an interview with a study researcher. This interview is designed to find out whether or not the questions in the questionnaire are the most useful and important ones to ask. The researcher will also ask whether
- You found the questions clear and easy to understand
- They were presented in a sensible order
- You found any of the questions difficult to answer because they ask about sexual difficulties
You have this interview on the day of a routine appointment, in a private room close to your clinic or at time convenient to you and the researcher in your own home or at Kings College, University of London. This interview should not last longer than an hour. If you agree, the researcher will make an audio recording of the interview, or make detailed notes if you don’t want it to be recorded.
The next 200 women to be recruited will fill out the questionnaire at home and return it to the study team by post in a pre paid envelope. The team will look at any comments you make on the questionnaire to check that it is easy to use and would be suitable to help other women in the future.
After the team have looked at the feedback from this questionnaire and made any final changes to it, they will programme it into a laptop computer to use in part 3 of the study.
If you are one of the first 20 women to take part in stage 2, you will have your interview on the same day as your routine outpatient clinic appointment. If this is unsuitable for any reason, the team will arrange another time and date convenient for you.
The team do not expect that there will be any risks involved with taking part in this study. But if this study does raise issues that you would like to discuss further, they will be happy to give you information, or suggest other specialist sources of advice.
How to join a clinical trial
Dr Isabel White
Addenbrookes NHS Trust
Barts Health NHS Trust
Experimental Cancer Medicine Centre (ECMC)
Gateshead Health NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
King's College London
Macmillan Cancer Support
National Institute for Health Research Cancer Research Network (NCRN)
Royal United Hospital Bath NHS Trust
The Christie NHS Foundation Trust
The Royal Marsden NHS Foundation Trust