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Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter (QASICC-EVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01616537
Recruitment Status : Terminated
First Posted : June 11, 2012
Last Update Posted : November 16, 2015
Information provided by (Responsible Party):
Centre Antoine Lacassagne

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

Condition or disease Intervention/treatment Phase
Malignant Mast Cell Tumors Solid Organ Sites Other: QUALITY OF LIFE QUESTIONNAIRE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 990 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter: Confirmatory Validation of QASICC Questionnaire
Study Start Date : November 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Intervention Details:
    Other Names:
    • QASICC
    • EORTC QLQ-C30

Primary Outcome Measures :
  1. QASICC questionnaire's 27 items tested on 990 patients to confirm the internal structure [ Time Frame: 30 days (+/- 7 days) after CVC implantation ]
    • Items quality
    • Dimensional structure
    • Dimensional consistence
    • Measure accuracy
    • Measure reliability
    • Sensitivity to change

Secondary Outcome Measures :
  1. Questionnaire's 27 items tested on 990 patients to confirm QASICC external structure: convergent-divergent validity compared to EORTC-QLQC30 questionnaire. [ Time Frame: 30 days (+/-7 days) after CVC implantation ]
    convergent-divergent validity of the QASICC questionnaire compared to EORTC-QLQC30 questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01616537

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Centre Paul Papin - Ico
Angers, France, 49933
Centre Francois Baclesse
Caen, France, 14076
Chu La Timone
Marseille, France, 13000
Chu de Montpellier
Montpellier, France, 34295
Centre Antoine Lacassagne
Nice, France, 06189
Institut Jean Godinot
Reims, France, 51056
Centre Rene Huguenin
Saint Cloud, France, 92210
Centre Paul Strauss
Strasbourg, France, 67065
Institut Claudius Regaud
Toulouse, France, 31052
Centre Alexis Vautrin
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Centre Antoine Lacassagne
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Principal Investigator: PIERRE YVES MARCY, MD Centre Antoine Lacassagne

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Responsible Party: Centre Antoine Lacassagne Identifier: NCT01616537    
Other Study ID Numbers: 2011-A01063-38
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: February 2013
Keywords provided by Centre Antoine Lacassagne:
solid tumors
hematological malignancy
Additional relevant MeSH terms:
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Mast-Cell Sarcoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type