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

NCT01181557 | Completed DMC

• 1 other identifier: INT-D176768
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma

  Three months postoperative time

• Questionnaire number 3, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma

  Six months after postoperative time

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Rectal cancer

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Milan, Italy, 20133, Italy

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• alberto vannelli, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: August 13, 2010
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 13, 2010

Record last verified: 2008-07

Locations

IT (1)