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

August 12, 2010 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Prospective Evaluation of Quality of Life in Patient With Rectal Cancer

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients admitted to hospital for rectal cancer, Italian resident older than 18 years, without history of psychiatric illness, or preoperative radiotherapy, dived in two cohorts patient with stoma after surgery and patients without stoma after surgery

Description

Inclusion Criteria:

  • Rectal cancer

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
rectal cancer with stoma
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 after stoma reconversion
rectal cancer without stoma
rectal cancer submitted to rectal anterior resection (RAR) Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later
anterior resection of rectum
patients with rectal cancer submitted to RAR and patients with rectal cancer submitted to RARS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Time Frame: 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.
three month: first admission in hospital preoperative time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Time Frame: 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.
Three months postoperative time
Questionnaire number 3, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Time Frame: 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.
Six months after postoperative time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

August 12, 2010

First Posted (ESTIMATE)

August 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2010

Last Update Submitted That Met QC Criteria

August 12, 2010

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT-D176768

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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