Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter
QASICC-EVA
1 other identifier
interventional
990
1 country
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2011
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedNovember 16, 2015
February 1, 2013
2 years
June 7, 2012
November 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
QASICC questionnaire's 27 items tested on 990 patients to confirm the internal structure
* Items quality * Dimensional structure * Dimensional consistence * Measure accuracy * Measure reliability * Sensitivity to change
30 days (+/- 7 days) after CVC implantation
Secondary Outcomes (1)
Questionnaire's 27 items tested on 990 patients to confirm QASICC external structure: convergent-divergent validity compared to EORTC-QLQC30 questionnaire.
30 days (+/-7 days) after CVC implantation
Interventions
QASICC AND EORTC QLQ-C30 ADMINISTRATION 30 DAYS AFTER CVC IMPLANTATION
Eligibility Criteria
You may qualify if:
- years and older
- Patient who benefited or will benefit from the implantation of a CVC
- Solid tumor or hematologic malignancy
- WHO Performance Status 0-2
You may not qualify if:
- Any severe psychopathological disorder preventing completion of the questionnaire or invalidating questionnaire's measures
- Severe depressive state
- Non malignant pathology
- Inability to respond to questionnaires
- Patient not speaking fluent French
- Patient unable to consent
- Patient under guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Centre Paul Papin - Ico
Angers, 49933, France
Centre Francois Baclesse
Caen, 14076, France
Chu La Timone
Marseille, 13000, France
Chu de Montpellier
Montpellier, 34295, France
Centre Antoine Lacassagne
Nice, 06189, France
Institut Jean Godinot
Reims, 51056, France
Centre Rene Huguenin
Saint-Cloud, 92210, France
Centre Paul Strauss
Strasbourg, 67065, France
Institut Claudius Regaud
Toulouse, 31052, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PIERRE YVES MARCY, MD
Centre Antoine Lacassagne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 11, 2012
Study Start
November 1, 2011
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
November 16, 2015
Record last verified: 2013-02