Clinical trial · Interventional
Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter
Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter: Confirmatory Validation of QASICC Questionnaire
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Mast Cell Tumors | Malignant Mastocytosis | ALIAS | 0.90 |
| Solid Organ Sites | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QUALITY OF LIFE QUESTIONNAIRE | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- QASICC questionnaire's 27 items tested on 990 patients to confirm the internal structure
- timeFrame
- 30 days (+/- 7 days) after CVC implantation
- description
- * Items quality * Dimensional structure * Dimensional consistence * Measure accuracy * Measure reliability * Sensitivity to change
Secondary outcomes (1)
- measure
- Questionnaire's 27 items tested on 990 patients to confirm QASICC external structure: convergent-divergent validity compared to EORTC-QLQC30 questionnaire.
- timeFrame
- 30 days (+/-7 days) after CVC implantation
- description
- convergent-divergent validity of the QASICC questionnaire compared to EORTC-QLQC30 questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available