Clinical trial NCT01616537: Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter
Official title: Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter: Confirmatory Validation of QASICC Questionnaire
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malignant Mast Cell Tumors
Solid Organ Sites
Keywords: solid tumors
hematological malignancy
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 990
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: QASICC questionnaire's 27 items tested on 990 patients to confirm the internal structure
timeFrame: 30 days (+/- 7 days) after CVC implantation
Secondary outcomes:
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
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin - Ico
city: Caen
country: France
facility: Centre Francois Baclesse
city: Marseille
country: France
facility: Chu La Timone
city: Montpellier
country: France
facility: Chu de Montpellier
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Centre Antoine Lacassagne
name: PIERRE YVES MARCY, MD
role: PRINCIPAL_INVESTIGATOR
References: