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
  Purpose

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.


Condition Intervention
Gastric Cancer
Other: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 267
Study Start Date: April 2001
Study Completion Date: January 2004
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020826

Locations
France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Germany
Universitaetsklinikum Charite
Berlin, Germany, D-10117
University of Marburg
Marburg, Germany, D-35033
Spain
Hospital De Navarra
Pamplona, Spain, 31080
Sweden
Sahlgrenska University Hospital
Gothenburg (Goteborg), Sweden, S-413 45
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Royal Infirmary
Glasgow, Scotland, United Kingdom, G4 0SF
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Jane Blazeby, MB, CHB, FRCS, BSc, MD University Hospitals Bristol NHS Trust
Study Chair: Thierry Conroy, MD Centre Alexis Vautrin
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00020826     History of Changes
Other Study ID Numbers: EORTC-15001-40003, EORTC-15001, EORTC-40003
Study First Received: July 11, 2001
Last Updated: August 24, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on October 23, 2014