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

Prospective Evaluation of Quality of Life in Patient With Rectal Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01181557

Enrollment

236

Registered

2010-08-13

Start date

2008-09-30

Completion date

2009-12-31

Last updated

2010-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

quality of life

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Rectal cancer

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma	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.

Secondary

Measure	Time frame	Description
Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma	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	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.

Countries

Italy

Outcome results