A Questionnaire to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma

Completed

• Conditions: Rectal Cancer

• Registration Number: NCT01181557
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary

The aim of the present prospective study was to evaluate the prediction accuracy of EORTC QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to investigate how the quality of life (QoL) of patients with rectal cancer changes with time after cancer or after stomia.

Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to EORTC QLQ-C30/C38 questionnaire.

Detailed Description

Eligibility criteria: Italian people with adenocarcinoma of rectum. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.

Outcome measures: patient was carried out using a EORTC QLQ-C30/C38 questionnaire.To determine how surgery affects QoL, we divided patients into two groups: first rectal cancer submitted to rectal anterior resection(RAR) and latter rectal cancer submitted to rectal anterior resection with stomia(RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later of after the stoma reconversion in RARS patients

Study Timeline

• Status Verified: 2008-07
• Study Start: 2008-09
• Primary Completion: 2009-08
• Study Completion: 2009-12
• Study First Submitted: 2010-04-01
• Study First Submitted QC: 2010-08-12
• Last Update Submitted: 2010-08-12
• Study First Posted: 2010-08-13
• Last Update Posted: 2010-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• Rectal cancer

Exclusion Criteria

• Age younger than 18 years
• History of psychiatric illness
• Preoperative radiotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma	three month: first admission in hospital preoperative time	Two cohort in preoperative time: first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.

Secondary Outcome Measures

Name	Time	Method
Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma	Three months postoperative time	Two cohort in postoperative time (three months after surgical procedure): first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.
Questionnaire number 3, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma	Six months after postoperative time	Two cohort in postoperative time (six months after postoperative time): first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; 🇮🇹 Milan, Italy