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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-15001 | Other Identifier | EORTC | |
| EORTC-40003 | Other Identifier | EORTC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gastric adenocarcinoma | No protocol specific interventions. Both palliative or curative treatment allowed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quality-of-life assessment | Other | QLQ-C30 questionnaire administered. STO22 questionnaire administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| psychometric validity of the STO22 module | Quality of life scores will be evaluated for psychometric validity by:
| The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| compliance | Proportion of completed versus expected QoL questionnaires | 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. |
DISEASE CHARACTERISTICS:
Histologically confirmed gastric adenocarcinoma
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:
No concurrent enrollment on other quality of life study that would interfere with this study
Not previously enrolled on this study
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jane Blazeby, MB, CHB, FRCS, BSc, MD | University Hospitals Bristol and Weston NHS Foundation Trust | Study Chair |
| Thierry Conroy, MD | Centre Alexis Vautrin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France | |||
| Universitaetsklinikum Charite |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18979141 | Result | 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. | |
| 19715606 |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| before and after treatment |
| Berlin |
| D-10117 |
| Germany |
| University of Marburg | Marburg | D-35033 | Germany |
| Hospital De Navarra | Pamplona | 31080 | Spain |
| Sahlgrenska University Hospital | Gothenburg (Goteborg) | S-413 45 | Sweden |
| Bristol Haematology and Oncology Centre | Bristol | England | BS2 8ED | United Kingdom |
| Royal Infirmary | Glasgow | Scotland | G4 0SF | United Kingdom |
| Result |
| 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. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |