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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045019
• Other study ID #: EORTC-15012
• Secondary ID: EORTC-15012
• Status: Completed
• Phase: N/A
• First received: September 6, 2002
• Last updated: August 24, 2012
• Start date: May 2002
• Est. completion date: March 2005

Study information

• Verified date: August 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 795
• Est. completion date: March 2005
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• quality-of-life assessment
QLQ-C30 SAT32

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels
France	Institut Bergonie	Bordeaux
France	Centre Regional Francois Baclesse	Caen
France	Institut Curie - Section Medicale	Paris
France	Centre Paul Strauss	Strasbourg
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif
Spain	Hospital De Navarra	Pamplona
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Uppsala University Hospital	Uppsala
United Kingdom	Bristol Royal Infirmary	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Spain,  Sweden,  United Kingdom,