Clinical trial NCT00020826: Assessing Quality of Life of Patients With Stomach Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: adenocarcinoma of the stomach
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
Secondary outcomes:
measure: debriefing questionnaire information
timeFrame: at baseline
Other outcomes:
measure: compliance
timeFrame: at the same timepoints when the QoL questionnaires are completed
measure: correlation between QLQ-C30 and STO22 scores
timeFrame: before and after treatment
Locations:
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
city: Berlin
country: Germany
facility: Universitaetsklinikum Charite
city: Marburg
country: Germany
facility: University of Marburg
city: Pamplona
country: Spain
facility: Hospital De Navarra
city: Gothenburg (Goteborg)
country: Sweden
facility: Sahlgrenska University Hospital
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: England
city: Glasgow
country: United Kingdom
facility: Royal Infirmary
state: Scotland
Study officials:
affiliation: University Hospitals Bristol and Weston NHS Foundation Trust
name: Jane Blazeby, MB, CHB, FRCS, BSc, MD
role: STUDY_CHAIR
affiliation: Centre Alexis Vautrin
name: Thierry Conroy, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.