Trial record 6 of 35 for:    "Cutaneous mastocytosis"

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT01616537
First received: June 7, 2012
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 Intervention
Malignant Mast Cell Tumors
Solid Organ Sites
Other: QUALITY OF LIFE QUESTIONNAIRE

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter: Confirmatory Validation of QASICC Questionnaire

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • QASICC questionnaire's 27 items tested on 990 patients to confirm the internal structure [ Time Frame: 30 days (+/- 7 days) after CVC implantation ] [ Designated as safety issue: No ]
    • Items quality
    • Dimensional structure
    • Dimensional consistence
    • Measure accuracy
    • Measure reliability
    • Sensitivity to change


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    convergent-divergent validity of the QASICC questionnaire compared to EORTC-QLQC30 questionnaire


Enrollment: 990
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: QUALITY OF LIFE QUESTIONNAIRE
    QASICC AND EORTC QLQ-C30 ADMINISTRATION 30 DAYS AFTER CVC IMPLANTATION
    Other Names:
    • QASICC
    • EORTC QLQ-C30
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616537

Locations
France
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
Investigators
Principal Investigator: PIERRE YVES MARCY, MD Centre Antoine Lacassagne
  More Information

No publications provided

Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT01616537     History of Changes
Other Study ID Numbers: 2011-A01063-38
Study First Received: June 7, 2012
Last Updated: February 20, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Antoine Lacassagne:
solid tumors
hematological malignancy

Additional relevant MeSH terms:
Mast-Cell Sarcoma
Mastocytoma
Mastocytosis
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014