Assessing Quality of Life of Patients With Stomach Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

October 13, 2009

Start Date ^ICMJE

April 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

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

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Gastric Cancer

Intervention ^ICMJE

Procedure: quality-of-life assessment

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

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

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 ID ^ICMJE

NCT00020826

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068717, EORTC-15001, EORTC-40003

Study Sponsor ^ICMJE

European Organization for Research and Treatment of Cancer

Collaborators ^ICMJE

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

National Cancer Institute (NCI)

Verification Date

August 2001

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