Assessing Quality of Life of Patients With Stomach Cancer

August 24, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

Completed

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

Observational

Enrollment (Actual)

267

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin
  • Germany
      • Berlin, Germany, D-10117
        • Universitaetsklinikum Charite
      • Marburg, Germany, D-35033
        • University of Marburg
  • Spain
      • Pamplona, Spain, 31080
        • Hospital de Navarra
  • Sweden
      • Gothenburg (Goteborg), Sweden, S-413 45
        • Sahlgrenska University Hospital
  • United Kingdom
    • England
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
    • Scotland
      • Glasgow, Scotland, United Kingdom, G4 0SF
        • Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

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.

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.
The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
debriefing questionnaire information
Time Frame: at baseline
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
compliance
Time Frame: at the same timepoints when the QoL questionnaires are completed
Proportion of completed versus expected QoL questionnaires
at the same timepoints when the QoL questionnaires are completed
correlation between QLQ-C30 and STO22 scores
Time Frame: before and after treatment
correlations between the different established scales of the QLQ-C30 and the hypothesized STO22 scales will be calculated.
before and after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 27, 2012

Last Update Submitted That Met QC Criteria

August 24, 2012

Last Verified

August 1, 2012

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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