- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00020826
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vandoeuvre-les-Nancy, France, 54511
- Centre Alexis Vautrin
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Berlin, Germany, D-10117
- Universitaetsklinikum Charite
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Marburg, Germany, D-35033
- University of Marburg
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Pamplona, Spain, 31080
- Hospital de Navarra
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Gothenburg (Goteborg), Sweden, S-413 45
- Sahlgrenska University Hospital
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England
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Bristol, England, United Kingdom, BS2 8ED
- Bristol Haematology and Oncology Centre
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Scotland
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Glasgow, Scotland, United Kingdom, G4 0SF
- Royal Infirmary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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gastric adenocarcinoma
No protocol specific interventions.
Both palliative or curative treatment allowed.
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QLQ-C30 questionnaire administered.
STO22 questionnaire administered.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Quality of life scores will be evaluated for psychometric validity by:
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The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
debriefing questionnaire information
Time Frame: at baseline
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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.
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at baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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compliance
Time Frame: at the same timepoints when the QoL questionnaires are completed
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Proportion of completed versus expected QoL questionnaires
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at the same timepoints when the QoL questionnaires are completed
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correlation between QLQ-C30 and STO22 scores
Time Frame: before and after treatment
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correlations between the different established scales of the QLQ-C30 and the hypothesized STO22 scales will be calculated.
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before and after treatment
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Collaborators and Investigators
Investigators
- Study Chair: Jane Blazeby, MB, CHB, FRCS, BSc, MD, University Hospitals Bristol and Weston NHS Foundation Trust
- Study Chair: Thierry Conroy, MD, Centre Alexis Vautrin
Publications and helpful links
General Publications
- Onate-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.
- Sadighi 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EORTC-15001-40003
- EORTC-15001 (Other Identifier: EORTC)
- EORTC-40003 (Other Identifier: EORTC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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