Assessing Quality of Life of Patients With Stomach Cancer
NCT ID: NCT00020826
Last Updated: 2012-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
267 participants
OBSERVATIONAL
2001-04-30
2004-01-31
Brief Summary
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PURPOSE: Clinical trial to study the effectiveness of a quality of life assessment in patients who are receiving treatment for stomach cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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gastric adenocarcinoma
No protocol specific interventions. Both palliative or curative treatment allowed.
quality-of-life assessment
QLQ-C30 questionnaire administered. STO22 questionnaire administered.
Interventions
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quality-of-life assessment
QLQ-C30 questionnaire administered. STO22 questionnaire administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Jane Blazeby, MB, CHB, FRCS, BSc, MD
Role: STUDY_CHAIR
University Hospitals Bristol and Weston NHS Foundation Trust
Thierry Conroy, MD
Role: STUDY_CHAIR
Centre Alexis Vautrin
Locations
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Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Universitaetsklinikum Charite
Berlin, , Germany
University of Marburg
Marburg, , Germany
Hospital De Navarra
Pamplona, , Spain
Sahlgrenska University Hospital
Gothenburg (Goteborg), , Sweden
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Royal Infirmary
Glasgow, Scotland, United Kingdom
Countries
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References
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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.
Other Identifiers
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EORTC-15001
Identifier Type: OTHER
Identifier Source: secondary_id
EORTC-40003
Identifier Type: OTHER
Identifier Source: secondary_id
EORTC-15001-40003
Identifier Type: -
Identifier Source: org_study_id