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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

August 24, 2012

Start Date ^ICMJE

April 2001

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00020826 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

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.

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Assessing Quality of Life of Patients With Stomach Cancer

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Gastric Cancer

Intervention ^ICMJE

Other: quality-of-life assessment

QLQ-C30 questionnaire administered. STO22 questionnaire administered.

Other Names:

QLQ-C30 questionnaire administered.
STO22 questionnaire administered.

Study Group/Cohort (s)

gastric adenocarcinoma

No protocol specific interventions. Both palliative or curative treatment allowed.

Intervention: Other: quality-of-life assessment

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

267

Completion Date

January 2004

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France, Germany, Spain, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00020826

Other Study ID Numbers ^ICMJE

EORTC-15001-40003, EORTC-15001, EORTC-40003

Has Data Monitoring Committee

Responsible Party

European Organisation for Research and Treatment of Cancer - EORTC

Study Sponsor ^ICMJE

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Jane Blazeby, MB, CHB, FRCS, BSc, MD	University Hospitals Bristol NHS Trust
Study Chair:	Thierry Conroy, MD	Centre Alexis Vautrin

Information Provided By

European Organisation for Research and Treatment of Cancer - EORTC

Verification Date

August 2012

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

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