Malignant Mast Cell Tumors Clinical Trial
Official 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
QASICC Questionnaire The QASICC questionnaire included 27 questions (Q) assessing seven
dimensions: pain during placement or use (Q1, Q2), contribution to the comfort of the
treatment (Q3, Q4, Q7, Q10, Q12), esthetics and privacy (Q5, Q6, Q8, Q11, Q17, Q19), the
impact on professional activities, social and sports (Q9, Q13, Q14, Q18, Q20), the impact on
daily activities (Q15, Q16, Q21, Q22 ), local discomfort (Q23, Q24, Q25, Q26) and overall
satisfaction (Q27). The device-related answers were of two types: Likert or visual analogue
scale. Four types of Likert response were available: "no", "low," "moderate,"
"significant,"/"never," "sometimes," "often," "always "/" very easy "," easy "," difficult
"," very difficult "/" not at all "," somewhat "," a lot "," extremely ". These questions
are scored 0, 33, 67, 100, respectively, when the scores are correlated with symptoms, or
100, 67, 33, 0 when the scores are inversely correlated with symptoms. Visual analog scales
(VAS) have a length of 100 mm. The score represents the number of mm measured on the scale.
A mean score of acceptance and satisfaction can be calculated on a scale of 0 to 100 for all
seven dimensions using the following formula: {(100-score DO) + CO + score (score ES-100) +
(100-PR score) + (100-ES score) + (score 100-IN) + SA score} / 7. The higher the overall
score, the greater the acceptance and satisfaction
The questionnaire is administered to the patient 30 days (+/-7 days) after CVC implantation.
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Intervention Model: Single Group Assignment, Masking: Open Label