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

This study has been completed.
Sponsor:
Information provided by:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT01181557
First received: April 1, 2010
Last updated: August 12, 2010
Last verified: July 2008
  Purpose

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.


Condition
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Quality of Life in Patient With Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma [ Time Frame: Three months postoperative time ] [ Designated as safety issue: No ]
    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 [ Time Frame: Six months after postoperative time ] [ Designated as safety issue: No ]
    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.


Enrollment: 236
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

  • Rectal cancer

Exclusion Criteria:

  • Age younger than 18 years
  • History of psychiatric illness
  • Preoperative radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181557

Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
Study Director: alberto vannelli, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  More Information

No publications provided

Responsible Party: Alberto Vannelli, Ermanno Leo, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01181557     History of Changes
Other Study ID Numbers: INT-D176768
Study First Received: April 1, 2010
Last Updated: August 12, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
quality of life

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 22, 2014