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

November 13, 2015 updated by: Centre Antoine Lacassagne

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

990

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Centre Paul Papin - Ico
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Marseille, France, 13000
        • CHU La Timone
      • Montpellier, France, 34295
        • CHU de Montpellier
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Reims, France, 51056
        • Institut Jean Godinot
      • Saint Cloud, France, 92210
        • Centre René Huguenin
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Vandoeuvre Les Nancy, France, 54511
        • Centre Alexis Vautrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days (+/- 7 days) after CVC implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days (+/-7 days) after CVC implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Antoine Lacassagne

Investigators

  • Principal Investigator: PIERRE YVES MARCY, MD, Centre Antoine Lacassagne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Estimate)

November 16, 2015

Last Update Submitted That Met QC Criteria

November 13, 2015

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A01063-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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