Patient reported outcomes in prostate cancer radiotherapy version 1.1
Research type
Research Study
Full title
Patient reported outcomes in patients treated within a randomised trial of image-guided radiotherapy for localised prostate cancer.
IRAS ID
144699
Contact name
David Dearnaley
Contact email
Sponsor organisation
The Institute of Cancer Research
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The development of new, complex radiotherapy technologies has lead to the introduction of image-guided radiotherapy (IGRT) in some radiotherapy centres in the UK. Image guided techniques can track a mobile organ like the prostate each day during treatment. This allows more accurate delivery of radiotherapy and IGRT may improve disease control. Also, it permits the margins around the prostate to be reduced resulting in less normal tissue being irradiated, which may reduce unwanted normal tissue radiotherapy effects.
IGRT requires more resources (equipment, treatment time, skills) and the potential benefits of this technique is being evaluated in the CHHiP trial, which was comparing different treatment schedules for the radiotherapy of prostate cancer. The CHHiP trial is a large UK trial, where 3216 men were recruited between October 2002 and June 2011 to either receive standard radiotherapy treatment with 37 treatments, or a shorter treatment duration of 19 or 20 treatments. Between July 2010 and June 2011, 293 patients entered into the main study, also consented to receive treatment within the CHHiP IGRT sub-study. The patients were randomized to receive their radiotherapy schedule either (i) without IGRT, (ii) with IGRT and standard prostate treatment margins or (iii) with IGRT and reduced margins.
Each patient during and after treatment within the CHHiP IGRT sub-study were asked questions by the team looking after them regarding urinary and bowel symptoms and sexual function. This information has been collected, however, there is evidence that this data does not correlate well with patients own documentation, in the form of patient completed questionnaires.
Therefore, this information is important to evaluate and previous studies have shown that after two years from completion of radiotherapy, patient reported measures are stable. Patients within the CHHiP IGRT sub-study have completed more than two years of follow up and we would like to offer patients treated within this sub-study the opportunity to document in the form of validated questionnaires their bowel, urinary and sexual function and quality of life.
This data would then be used with the other data already collected to evaluate the side effects in each treatment group.
Patients will be contacted via post with a participant information sheet, questionnaire pack and stamped addressed envelope. Completion of this questionnaire pack is completely voluntary and has no impact on their planned follow-up schedule within the CHHiP IGRT sub-study.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
14/SW/1071
Date of REC Opinion
19 Sep 2014
REC opinion
Further Information Favourable Opinion