Assessing Quality of Life of Patients With Stomach Cancer
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|ClinicalTrials.gov Identifier: NCT00020826|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 27, 2012
RATIONALE: Assessing quality of life in patients who are undergoing cancer treatment may help determine the effect of treatment on these patients.
PURPOSE: Clinical trial to study the effectiveness of a quality of life assessment in patients who are receiving treatment for stomach cancer.
|Condition or disease||Intervention/treatment|
|Gastric Cancer||Other: quality-of-life assessment|
- Determine the scale structure, reliability, and validity of the tumor-specific questionnaire, QLQ-STO22, in assessing the quality of life of patients with gastric cancer.
- Determine the questionnaire's sensitivity to change in clinical health status in these patients.
OUTLINE: Patients are stratified according to type of treatment (potentially curative vs potentially palliative), disease stage (local and locoregional vs metastatic), Karnofsky performance status (less than 80% vs more than 80%), and initial weight gain (none vs less than 10% of total body weight vs 10% or more of total body weight).
- Curatively Treated Group: Quality of life is assessed at 4 weeks prior to surgery and 3 months after surgery in patients receiving total or partial gastrectomy with curative intent; at 4 weeks prior to chemotherapy and/or radiotherapy, 4 weeks prior to surgery, and 3 months after surgery in patients receiving neoadjuvant chemotherapy and/or radiotherapy followed by total or partial gastrectomy with curative intent; at 4 weeks prior to chemotherapy and/or radiotherapy and 6 weeks after completion of therapy in patients receiving adjuvant chemotherapy and/or radiotherapy following total or partial gastrectomy; and at 4 weeks prior to therapy and 3 months after completion of therapy in patients receiving endoscopic mucosal resection or laparoscopic wedge resection.
- Palliatively Treated Group: Quality of life is assessed at 3 weeks prior to palliative therapy and 4 weeks after beginning palliative therapy.
PROJECTED ACCRUAL: Approximately 220 patients (110 per group) will be accrued for this study within 2 years.
|Study Type :||Observational|
|Actual Enrollment :||267 participants|
|Official Title:||An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (The QLQ-STO22) In Assessing The Quality Of Life Of Patients With Gastric Cancer|
|Study Start Date :||April 2001|
|Primary Completion Date :||May 2003|
|Study Completion Date :||January 2004|
No protocol specific interventions. Both palliative or curative treatment allowed.
Other: quality-of-life assessment
QLQ-C30 questionnaire administered. STO22 questionnaire administered.
- psychometric validity of the STO22 module [ Time Frame: The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment. ]
Quality of life scores will be evaluated for psychometric validity by:
- Scale structure using multi-trait scaling analysis
- Reliability using tests of internal consistency
- Test-retest reliability in patients recruited in the UK
- Validity using inter-scale correlations and known group comparisons
- Sensitivity to change using two measurements of Quality of Life and ANOVA to look for the significance of changes in quality of life scores as a function of observed changes in clinical status over time.
- debriefing questionnaire information [ Time Frame: at baseline ]Patients will be asked to complete a short debriefing questionnaire covering questions about the time taken to complete the EORTC QLQ-C30 and QLQ-STO22; the need for help in completing the questionnaires and querying whether any of the questionnaire items were confusing; difficult to answer or upsetting.
- compliance [ Time Frame: at the same timepoints when the QoL questionnaires are completed ]Proportion of completed versus expected QoL questionnaires
- correlation between QLQ-C30 and STO22 scores [ Time Frame: before and after treatment ]correlations between the different established scales of the QLQ-C30 and the hypothesized STO22 scales will be calculated.
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): NCT00020826
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Berlin, Germany, D-10117|
|University of Marburg|
|Marburg, Germany, D-35033|
|Hospital De Navarra|
|Pamplona, Spain, 31080|
|Sahlgrenska University Hospital|
|Gothenburg (Goteborg), Sweden, S-413 45|
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|Glasgow, Scotland, United Kingdom, G4 0SF|
|Study Chair:||Jane Blazeby, MB, CHB, FRCS, BSc, MD||University Hospitals Bristol NHS Foundation Trust|
|Study Chair:||Thierry Conroy, MD||Centre Alexis Vautrin|