Assessing Quality of Life of Patients With Stomach Cancer

European Organisation for Research and Treatment of Cancer (EORTC)

Status: Completed

Conditions: Gastric Cancer

Treatments: Other: quality-of-life assessment

Study type: Observational

Funder types: NETWORK

Identifiers

NCT00020826

EORTC-40003 (Other Identifier)

EORTC-15001 (Other Identifier)

EORTC-15001-40003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

267 participants in 1 patient group

gastric adenocarcinoma

Description:

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

Treatment:

Other: quality-of-life assessment