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Assessing Quality of Life of Patients With Stomach Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00020826
First received: July 11, 2001
Last updated: August 24, 2012
Last verified: August 2012

July 11, 2001
August 24, 2012
April 2001
May 2003   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]

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.
Not Provided
Complete list of historical versions of study NCT00020826 on ClinicalTrials.gov Archive Site
debriefing questionnaire information [ Time Frame: at baseline ] [ Designated as safety issue: No ]
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.
Not Provided
  • compliance [ Time Frame: at the same timepoints when the QoL questionnaires are completed ] [ Designated as safety issue: No ]
    Proportion of completed versus expected QoL questionnaires
  • correlation between QLQ-C30 and STO22 scores [ Time Frame: before and after treatment ] [ Designated as safety issue: No ]
    correlations between the different established scales of the QLQ-C30 and the hypothesized STO22 scales will be calculated.
Not Provided
 
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Gastric Cancer
Other: quality-of-life assessment
QLQ-C30 questionnaire administered. STO22 questionnaire administered.
Other Names:
  • QLQ-C30 questionnaire administered.
  • STO22 questionnaire administered.
gastric adenocarcinoma
No protocol specific interventions. Both palliative or curative treatment allowed.
Intervention: Other: quality-of-life assessment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
267
January 2004
May 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Spain,   Sweden,   United Kingdom
 
NCT00020826
EORTC-15001-40003, EORTC-15001, EORTC-40003
No
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Jane Blazeby, MB, CHB, FRCS, BSc, MD University Hospitals Bristol NHS Foundation Trust
Study Chair: Thierry Conroy, MD Centre Alexis Vautrin
European Organisation for Research and Treatment of Cancer - EORTC
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP