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Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter

NCT01616537 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 990

Last updated 2015-11-16

No results posted yet for this study

Summary

Background Patient satisfaction with or acceptance of care assessment is increasingly taken into account in oncology. Most cancer and other critically-ill patients require a totally-implanted Central Venous Catheter (CVC) for their treatment consisting of a reservoir connected to a central venous catheter, which may or may not be valved. It is impossible to estimate the number of CVC used in oncology. However, some authors claim that, in 2005, over 7 million CVCs were placed in the United States in both chronic and acute care. Although many patients fitted with a CVC are able to undertake activities which are hindered with other external vascular access devices, they are often physically or psychologically anxious about their device. To our knowledge, no validated questionnaire measuring patient acceptance of and satisfaction with their CVC has been reported in the literature. Based on these observations, the aim of our study was to develop and to validate a French-language questionnaire dubbed QASICC (Questionnaire for Acceptance of and Satisfaction with Implanted Central Venous Catheter) assessing patient satisfaction with and acceptance of their CVC. QASICC is designed as a multi-dimensional, self-administered questionnaire comprising approximately 30 items related to the use, appearance and pros and cons of the device as well as quality of life as perceived by patients using one for treatment.

Objective The purpose of the study is to validate a French-language self-administered questionnaire (QASICC) designed to evaluate patients' satisfaction and acceptance concerning their totally-implanted central venous catheter: confirmatory validation of questionnaire psychometric properties.

Study Design This is a prospective, multicenter, open study.

Primary Outcome Measures:

Questionnaire's 27 items tested on 990 patients to confirm QASICC internal structure:

* Items quality
* Dimensional structure
* Dimensional consistence
* Measure accuracy
* Measure reliability
* Sensitivity to change

Conditions

  • Malignant Mast Cell Tumors
  • Solid Organ Sites

Interventions

OTHER

QUALITY OF LIFE QUESTIONNAIRE

QASICC AND EORTC QLQ-C30 ADMINISTRATION 30 DAYS AFTER CVC IMPLANTATION

Sponsors & Collaborators

  • Centre Antoine Lacassagne

    lead OTHER

Principal Investigators

  • PIERRE YVES MARCY, MD · Centre Antoine Lacassagne

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01616537 on ClinicalTrials.gov