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))

Not Applicable

Completed

• Conditions: All cancers located in pelvic region treated with radiation therapy; Cancer - Prostate; Cancer - Womb (Uterine or endometrial cancer); Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12609000972224
• Lead Sponsor: EORTC Quality of Life Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Receiving a curative dose of radiation therapy to pelvis (50-70Gy)

Exclusion Criteria

Participants will be ineligible for the study if they have previously received radiation therapy, the radiation dose prescribed is less than 50 Gy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proctitis symptoms will be measured using the proctitis module developed (EORTC PRT-23)<br><br>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<br>During first week of treatment<br>Completion of treatment<br>Post treatment (3-6 months)]

Secondary Outcome Measures

Name	Time	Method
/A[N/A]