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

Rectal Cancer Clinical Trial

Official title:

Prospective Evaluation of Quality of Life in Patient With Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181557
• Other study ID #: INT-D176768
• Status: Completed
• Phase: N/A
• First received: April 1, 2010
• Last updated: August 12, 2010
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: July 2008
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Rectal cancer

Exclusion Criteria:

• Age younger than 18 years

• History of psychiatric illness

• Preoperative radiotherapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma	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.	three month: first admission in hospital preoperative time	No
Secondary	Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma	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.	Three months postoperative time	No
Secondary	Questionnaire number 3, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma	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.	Six months after postoperative time	No