Study to Assess Cancer Patients' Satisfaction With Hospit... | NCT00045019

ID	Type	Description	Link
EORTC-15012	Other Identifier	EORTC

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Jun 2004Actual

Completion Date

Mar 2005Actual

First Submitted Date

Sep 6, 2002

First Submission Date that Met QC Criteria

Jan 26, 2003

First Posted Date

Jan 27, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2012

Last Update Posted Date

Aug 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

795Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
quality-of-life assessment	Other	QLQ-C30 SAT32	discharged cancer patients

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

cancer patients discharged from a surgery or medical ward of oncology institute.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Institut Jules Bordet		Brussels		1000	Belgium
Institut Bergonie