An international field study of the reliability and validity of a proctitis specific quality of life module (European Organisation for Research and Treatment of Cancer Quality of Life Module for Proctitis-23 items (EORTC QLQ-PRT23))

Plan of Investigation The primary objective of Phase IV of the study will be to test the scale structure, reliability and validity and cross-cultural applicability of the proctitis module (EORTC QLQ-PRT23) to be used alone or together with the EORTC Quality of Life Questionnaire (EORTC QLQ-C30) in patients who are receiving radiation therapy to their pelvic region. Participants Patients will be recruited from collaborating hospitals in Australia, Norway, Germany, Italy and France. This will enable the testing of the questionnaire in Anglo-Saxon countries, Northern Europe and Southern Europe. We aim to recruit patients who have received a curative dose of radiation therapy to their pelvic region (50-70Gy). This will include tumours located in the following sites: prostate, cervix and rectum. Patients will be eligible for the study if they are receiving a radical course of pelvic irradiation (50-70 Gy) and able to converse freely in the language that the questionnaire is written. Participants will be ineligible for the study if they have previously received radiation therapy, the radiation dose prescribed is less than 50 Gy and they are participating in other Quality of Life trials that might interfere with this study. Trial Design This is a cross-sectional longitudinal descriptive study, which collects Quality of Life data alongside socio-demographic and clinical background data at three time points during the patients’ radiation therapy treatment. The following time points will be used to test for acute proctitis: 1. At least two (2) weeks prior to radiotherapy treatment (when they see their clinician); 2. During the first (1st) week of treatment; 3. At the end of treatment; 4. At the three (3) to six (6) months scheduled follow-up appointment, after treatment completion. Patients will be asked to complete the first questionnaire when they are seeing their clinician during a routine visit. On subsequent occasions the questionnaire will be either provided when they present for treatment or alternatively posted to them with reply paid envelopes so that patients can post these questionnaires back to them. Administration of the questionnaire at these time points will facilitate evaluation of how the patients’ experiences of acute proctitis change as they proceed through treatment. Socio-demographic details collected will include age, geographical location, education and clinical background data will include diagnosis, tumour site and radiation dose prescribed. Patients will be stratified by treating centre and tumour site. A second group of participants will be asked to complete questionnaires at two time points once treatment is complete to measure chronic proctitis. The time points used will be 1. When patient is experiencing ‘moderate to severe’ symptoms; 2. When patient is experiencing ‘minor to mild’ symptoms. Patients who participate in the study will be asked to complete a demographics questionnaire, the EORTC QLQ-C30 and the proctitis module (EORTC QLQ-PRT23). They will then be asked to respond to the following questions as recommended by the EORTC quality of life group: a) How long did it take you to complete the questionnaire? b) Did anyone help you to complete the questionnaire? c) Were there questions that you found confusing or difficult to answer? d) Were there questions that you found upsetting? The clinicians involved in treating these patients and identifying them for the study will be asked to complete the EORTC Tadiation Therapy Oncology Group classification system for each patient at each time point. Data collection will occur over a period of three years.