Quality of Life Sub-study (UK only)
There will be several sub-studies running alongside the main trial, one such study is The Quality of Life (QoL). There has been a lot of research into the contribution of mastectomy and chemotherapy to QoL, but less so on the effect of radiotherapy on quality of life in patients who have undergone a mastectomy.
It is hoped that most hospitals in the UK will agree to ask their patients to take part in the QoL sub study. The assessments will take the form of patient questionnaires, similar to those used in other trials which patients have not found too difficult or time-consuming. The first questionnaire will be explained to you and completed in the clinic. Further questionnaires will be sent out to you at 1, 2, 5 and 10 years after your treatment.
It is important that we use questionnaires which are the same as those that are already being used in other national breast cancer trials so that we can compare results more easily. We think that the most likely symptoms will be fatigue, chest wall symptoms, appearance of the chest wall and anxiety and depression, but we will also monitor physical health, social effects and any specific adverse effects.
Your General Practitioner (GP) will be informed that you are taking part in the study and with your permission will be advised of any clinically significant information that comes to light.