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))

ABSTRACT: Interventions: 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 Primary outcome(s): Proctitis symptoms will be measured using the proctitis module developed (EORTC PRT-23) Proctitis is an unpleasant recurrent clinical syndrome that is manifest by bouts of the following symptoms: anorectal pain, profuse rectal bleeding or blood clots, explosive bowel urgency, frequent diarrhoea, profuse mucous discharge, faecal and/or mucous incontinence[Prior to radiation therapy During first week of treatment Completion of treatment Post treatment (3-6 months)] Study Design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective

DISEASE(S): Cancer-womb (uterine Or Endometrial Cancer),Cancer-prostate,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),All Cancers Located In Pelvic Region Treated With Radiation Therapy

PROVIDER: 2455292 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR