Title: Development of an intervention to reduce distress caused by brachytherapy for locally advanced cervical cancer
Funder: Health Education England

Abstract: Introduction The standard treatment for locally advanced cervical cancer is chemotherapy and radiotherapy including brachytherapy. Brachytherapy, a type of internal radiation therapy, where applicators are placed in the uterus and vagina is offered at 40 radiotherapy departments in the UK. In the past brachytherapy treatment used low dose rate (LDR) radioactive sources with treatment times typically 2-3 days. Newer treatments use a high dose rate (HDR) source so the treatment is delivered in minutes, but multiple treatments (3-5) are required to give equivalent radiobiological effect. Technical developments in gynaecological brachytherapy, using MR imaging to plan dose delivery and the addition of hollow needles into the cervix tumour itself, have been shown to increase local tumour control and reduce side effects. The treatment requires women to have the applicators/needles inserted in a theatre and to remain still on a bed for the planning and treatment period. Some centres give HDR brachytherapy as a day case procedure. Other centres keep patients in hospital overnight with applicators remaining in place and repeat treatments over 2-3 days. The impact of these technical and scheduling changes on patient experience and psychological distress is a growing concern among clinicians as we do not know how much this contributes to distress. A systematic review found 23 studies reporting women's experiences of brachytherapy. These studies were focussed in two main areas: descriptions of women's psychological experiences such as stress, anxiety, distress, humiliation, pain and use of complementary strategies to reduce distress; anaesthetic/analgesia and sedation methods during brachytherapy. Mostly pain was found to be mild to moderate, but some women experienced severe pain. Some reported that women said it was their worst ever experience. There was found to be no standard way of delivering the treatment or methods of helping women to cope. It is proposed that both physical and psychological distress during and after brachytherapy should be examined, for both day case (single insertion per treatment) and inpatient admissions (multiple treatments per insertion). This will inform the development of an intervention to improve patient experience of this highly effective but invasive treatment.Method Exploratory phase: A UK survey of practice to find out what service provision, pain management, and psychological support is in place in different centres. This will be via an online questionnaire sent to the 40 UK centres carrying out gynaecological brachytherapy. From this appropriate collaborative centres will be identified. Semi-structured patient interviews will be carried out with 25 women from 5 UK centres, up to 6 weeks after completion of brachytherapy for cervical cancer. Centres will be enlisted to allow exploration of patient experiences across a range of techniques and pathways in current UK practice. Transcribed interviews will be analysed using systematic thematic analysis. This will be used to develop a patient experience questionnaire. A patient experience questionnaire will be completed by over 200 patients from UK centres. The questionnaire will provide free text opportunities so both qualitative and quantitative data will be obtained. The data will be analysed to quantify the experiences of women and qualitative data by thematic analysis to add to the information from the in-depth interviews. Intervention development phase: Mapping patient behaviours and experiences of distress to design and development of the intervention- eg group support, online support, information leaflet, pain management guidelines etc. Final phase to establish proof of concept: Testing of the intervention with a small number of patients, to test acceptability, uptake and material provision. Results/Conclusion It is anticipated that an intervention will be developed to reduce distress, which may include a combination of group support, online support, information leaflet, pain management guidelines, non-pharmacological strategies and psychological strategies.

Lay abstract: Brachytherapy, a type of internal radiation therapy, is a treatment offered to women with cervix cancer. It is given after a course of external radiotherapy and chemotherapy to women with locally advanced cervical cancer, usually when surgery is not possible. It involves placing a number of applicators like hollow tubes inside the womb and then putting a radioactive source into the applicators to deliver a dose of radiation to kill cancer cells.Some centres give brachytherapy in 3 or 4 day case procedures. Others give treatments with 1 or 2 overnight stays, with applicators remaining in place for up to 48 hours. Women have to stay in bed and not move while the applicators are inside them, but may have less visits and less anaesthetics overall. These different regimes are thought to be equally as effective in controlling the cancer, but we do not know how much this affects women's experiences.The researcher has looked at all the published studies that tell us about women's experiences and written a report called a systematic literature review. This has found a number of reports that have shown a significant proportion of women who experienced a lot of physical and psychological distress during and after brachytherapy. The causes of distress appears to be quite complicated, with many different factors such as anxiety, pain, memories of pain from their last treatment, lying in a room on their own for a long time, having to lie still for a long time while applicators are inside them and the amount of time feeling embarrassed and humiliated. One study showed that over 4 in 10 women had symptoms of post-traumatic stress disorder 3 months after finishing brachytherapy. A number of other studies found that pain was generally mild to moderate, but that a small number of women suffered with severe pain. Some studies have looked at different ways of giving anaesthetics and pain killers to try and lower pain levels. Some used general anaesthetics where a patient is unconscious, some gave numbing injections into the spine and some sprayed local anaesthetic onto the cervix itself. They have measured pain and other side effects to try and find out what works best. Overall it was found that there is no standard way of giving anaesthetics and pain killers and is likely to be dependent on availability and cost of resources. Also, the amount of time for the procedure varies a lot, and some methods will be better suited to shorter or longer treatment times.To be able to find a way to reduce distress from brachytherapy, we need to understand better what parts of the treatment causes most upset to women. Also we want to find out what women found helped them cope, and what they think would have made it better for them. To find this out the study will have 3 stages:1. Exploratory stageA survey of all UK radiotherapy departments to find out how they give brachytherapy, what type of anaesthetics, what painkillers, how long it takes and how many treatments, and if any extra support like counselling is offered to help women cope.Interviews with 25 women, from 5 different hospitals who do the treatment in different waysA survey of over 200 women across to find out what they had experienced. 2. Development of an intervention (to reduce distress) From the information collected, the researcher will work out what needs to be done to help women cope better with brachytherapy. This may include better pain control, relaxation therapies like music videos or counselling.3. Testing the intervention A small number of women will try out the intervention to see if it can be used to help them cope. With advances in computer technology, this leads to ways of planning the treatment so that higher radiation doses can be given to the cervix cancer, and reducing doses to the normal tissues close by, such as bowel, and bladder. This means that cure rates can go up and side effects go down, but overall time for highly skilled staff time is likely to increase and therefore time to give the treatments will be longer. So trying to help women cope with this longer time will be increasingly important in the future.Overall the aim of this study is to develop an intervention to help women cope better with this highly effective but potentially distressing treatment.

Research activity codes: 6.5 RADIOTHERAPY AND OTHER NON-INVASIVE THERAPIES
Health categories: CANCER AND NEOPLASMS