Clinical trial · Observational
Assessing Quality of Life of Patients With Stomach Cancer
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
NCT00020826CI-TRIAL-00007894completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quality-of-life assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- gastric adenocarcinoma
- description
- No protocol specific interventions. Both palliative or curative treatment allowed.
- interventionNames
- Other: quality-of-life assessment
Primary outcomes (1)
- measure
- psychometric validity of the STO22 module
- timeFrame
- The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment.
- description
- 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.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed gastric adenocarcinoma * Patients treated with curative intent according to one of the following criteria: * Plan to undergo total or partial gastrectomy with curative intent * Plan to receive neoadjuvant chemotherapy and/or radiotherapy followed by total or partial gastrectomy with curative intent * Prior total or partial gastrectomy with curative intent and currently receiving adjuvant chemotherapy and/or radiotherapy * Prior endoscopic mucosal resection or laparoscopic wedge resection of early gastric cancer OR * Patients with initial diagnosis of gastric cancer or recurrent disease with plans to receive one of the following therapies with palliative intent: * Total or partial gastrectomy or bypass procedure * Endoscopic procedure (e.g., stent insertion) * Chemotherapy and/or radiotherapy * Supportive measures only * No concurrent enrollment on other quality of life study that would interfere with this study * Not previously enrolled on this study PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Any performance status Life expectancy: * At least 2 months for patients treated with curative intent * At least 4 weeks for patients treated with palliative intent Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other concurrent malignancies except basal cell carcinoma of the skin * No mental impairment that would preclude completion of questionnaire * No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics
References
Publications (2)
- RESULTOnate-Ocana LF, Alcantara-Pilar A, Vilar-Compte D, Garcia-Hubard G, Rojas-Castillo E, Alvarado-Aguilar S, Carrillo JF, Blazeby JM, Aiello-Crocifoglio V. Validation of the Mexican Spanish version of the EORTC C30 and STO22 questionnaires for the evaluation of health-related quality of life in patients with gastric cancer. Ann Surg Oncol. 2009 Jan;16(1):88-95. doi: 10.1245/s10434-008-0175-9. Epub 2008 Nov 1. PMID 18979141
- RESULTSadighi S, Montazeri A, Sedighi Z, Mohagheghi MA, Froutan H. Quality of life in patients with gastric cancer: translation and psychometric evaluation of the Iranian version of EORTC QLQ-STO22. BMC Cancer. 2009 Aug 28;9:305. doi: 10.1186/1471-2407-9-305. PMID 19715606