An observational study in Gastric Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 7 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-27.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Observational
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.
OBJECTIVES:
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).
PROJECTED ACCRUAL: Approximately 220 patients (110 per group) will be accrued for this study within 2 years.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 267 is close to the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study sample will be composed of a consecutive series of patients with gastric cancer meeting the eligibility criteria in each participating centre. The definition of gastric cancer is adenocarcinoma of the stomach, and includes all tumours of the fundus, body and antrum, linitis plastica and tumours of the cardia that infiltrate the gastro-oesophageal junction and distal oesophagus from below; classified as type III according to Siewert (1998. The study sample will be stratified by treatment - potentially curative and purely palliative.
DISEASE CHARACTERISTICS:
Patients treated with curative intent according to one of the following criteria:
Patients with initial diagnosis of gastric cancer or recurrent disease with plans to receive one of the following therapies with palliative intent:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
No protocol specific interventions. Both palliative or curative treatment allowed.
Other: quality-of-life assessment
QLQ-C30 questionnaire administered. STO22 questionnaire administered.
Also known as: QLQ-C30 questionnaire administered., STO22 questionnaire administered.
psychometric validity of the STO22 module
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.
Time frame: The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment.
debriefing questionnaire information
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.
Time frame: at baseline
compliance
Proportion of completed versus expected QoL questionnaires
Time frame: at the same timepoints when the QoL questionnaires are completed
correlation between QLQ-C30 and STO22 scores
correlations between the different established scales of the QLQ-C30 and the hypothesized STO22 scales will be calculated.
Time frame: before and after treatment
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC