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Completed

NCT Number: NCT00020826

Assessing Quality of Life of Patients With Stomach 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Alexis Vautrin, Vandœuvre-lès-Nancy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality-of-Life Assessment

Other

QLQ-C30 questionnaire administered. STO22 questionnaire administered.

Other names: QLQ-C30 questionnaire administered., STO22 questionnaire administered.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. compliance

    Time frame: at the same timepoints when the QoL questionnaires are completed

    Proportion of completed versus expected QoL questionnaires

  2. 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.

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2003
Study completion
2004
First posted
Jan 27, 2003
Registry last updated
Aug 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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