A Questionnaire to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
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ClinicalTrials.gov Identifier: NCT01181557 |
Recruitment Status :
Completed
First Posted : August 13, 2010
Last Update Posted : August 13, 2010
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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 or disease |
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Rectal Cancer |
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 |
Actual Enrollment : | 236 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Prospective Evaluation of Quality of Life in Patient With Rectal Cancer |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | December 2009 |
Group/Cohort |
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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
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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
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anterior resection of rectum
patients with rectal cancer submitted to RAR and patients with rectal cancer submitted to RARS
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- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Rectal cancer
Exclusion Criteria:
- Age younger than 18 years
- History of psychiatric illness
- Preoperative radiotherapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181557
Italy | |
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | |
Milan, Italy, 20133 |
Study Director: | alberto vannelli, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Responsible Party: | Alberto Vannelli, Ermanno Leo, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
ClinicalTrials.gov Identifier: | NCT01181557 |
Other Study ID Numbers: |
INT-D176768 |
First Posted: | August 13, 2010 Key Record Dates |
Last Update Posted: | August 13, 2010 |
Last Verified: | July 2008 |
quality of life |
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |