Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Study to Assess Cancer Patients' Satisfaction With Hospital Quality of Care

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Educational/Counseling/Training	Closed	18 and over	Other	EORTC-15012 NCT00045019

Objectives

1. Determine the scale structure, reliability, and validity of the QLQ-SAT32 patient satisfaction module in assessing the perception of the quality of care received in hospitals by patients with cancer.
2. Determine the success of the QLQ-SAT32 patient satisfaction module when used with the QLQ-C30 core quality of life questionnaire, in terms of expanding on quality of life evaluation or providing information on treatment acceptability or preference of these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed cancer
• Hospitalization of at least 3 days
• No clinical evidence of brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Prior chemotherapy allowed

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Prior surgery for cancer allowed

Other

• No concurrent participation in other quality of life studies that would preclude this study

Patient Characteristics:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No psychological, familial, sociological, or geographical condition that would preclude study
• Able to understand the language of the questionnaire
• Mentally fit to complete a questionnaire

Expected Enrollment

A total of 640-768 patients (160-192 per stratum) will be accrued for this study.

Outline

This is a descriptive, multicenter study. Patients are stratified according to age (18 to 49 vs 50 and over) and the cancer therapy received in hospital (surgery vs chemotherapy).

Patients in all strata receive the QLQ-SAT32 and QLQ-C30 questionnaires, a debriefing questionnaire, and the Oberst patient satisfaction visual analog scale prior to hospital discharge. Patients complete the materials at home within 7 days of discharge. A group of 100 patients have a repeat QLQ-SAT32 module mailed to them to be completed within 7 days of receipt of first questionnaire.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Anne Bredart, Study coordinator		Ph: 33-144-324-033

Registry Information
Official Title		An International Field-Testing Study Of The Reliability And Validity Of A Patient Satisfaction Module (QLQ-SAT32) Assessing Cancer Patients' Perception Of The Quality Of Care Received Within The Hospital
Trial Start Date		2002-05-31
Registered in ClinicalTrials.gov		NCT00045019
Date Submitted to PDQ		2002-06-19
Information Last Verified		2002-11-22

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