Malignant Mast Cell Tumors Clinical Trial
— QASICC-EVAOfficial title:
Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter: Confirmatory Validation of QASICC Questionnaire
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
| Status | Terminated |
| Enrollment | 990 |
| Est. completion date | December 2013 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 18 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 Exclusion Criteria: - 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 |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Paul Papin - Ico | Angers | |
| France | Centre Francois Baclesse | Caen | |
| France | Chu La Timone | Marseille | |
| France | Chu de Montpellier | Montpellier | |
| France | Centre Antoine Lacassagne | Nice | |
| France | Institut Jean Godinot | Reims | |
| France | Centre Rene Huguenin | Saint Cloud | |
| France | Centre Paul Strauss | Strasbourg | |
| France | Institut Claudius Regaud | Toulouse | |
| France | Centre Alexis Vautrin | Vandoeuvre Les Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Antoine Lacassagne |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Questionnaire's 27 items tested on 990 patients to confirm QASICC external structure: convergent-divergent validity compared to EORTC-QLQC30 questionnaire. | convergent-divergent validity of the QASICC questionnaire compared to EORTC-QLQC30 questionnaire | 30 days (+/-7 days) after CVC implantation | No |