Clinical trial NCT00045019: Study to Assess Cancer Patients' Satisfaction With Hospital Quality of Care
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 795
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cancer patients discharged from a surgery or medical ward of oncology institute.

Brief summary: RATIONALE: Questionnaires may help determine cancer patients' satisfaction with the quality of care they received in the hospital.

PURPOSE: Clinical trial to determine the effectiveness of questionnaires in assessing cancer patients' satisfaction with the quality of care they received in the hospital.

Detailed description: OBJECTIVES:

* 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.
* 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.

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.

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

Eligibility criteria: DISEASE CHARACTERISTICS:

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

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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Paris
country: France
facility: Institut Curie - Section Medicale
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Pamplona
country: Spain
facility: Hospital De Navarra
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
Study officials:
affiliation: Institut Curie
name: Anne Bredart
role: STUDY_CHAIR
References: