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

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ClinicalTrials.gov Identifier: NCT00045019
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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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.


Condition or disease Intervention/treatment
Unspecified Adult Solid Tumor, Protocol Specific Other: quality-of-life assessment

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.


Study Design
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Study Type : Observational
Actual Enrollment : 795 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : May 2002
Actual Primary Completion Date : June 2004
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
discharged cancer patients
patients discharged from a surgery or medical ward of oncology institutes in Belgium, France, Germany, Italy, Poland, Spain, Sweden, Taiwan and United Kingdom (as part of a larger psychometric validation study) were asked to rate there level of satisfaction, using the EORTC QLQ-SAT32.
 Other: quality-of-life assessment
QLQ-C30 SAT32
Other Name: QoL


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cancer patients discharged from a surgery or medical ward of oncology institute.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045019


Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
France
Institut Bergonie
Bordeaux, France, 33076
Centre Regional Francois Baclesse
Caen, France, 14076
Institut Curie - Section Medicale
Paris, France, 75231
Centre Paul Strauss
Strasbourg, France, 67085
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Spain
Hospital De Navarra
Pamplona, Spain, 31008
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45
Uppsala University Hospital
Uppsala, Sweden, S-75183
United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Anne Bredart Institut Curie
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00045019     History of Changes
Other Study ID Numbers: EORTC-15012
EORTC-15012 ( Other Identifier: EORTC )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 27, 2012
Last Verified: August 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
unspecified adult solid tumor, protocol specific