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Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter: Confirmatory Validation of QASICC Questionnaire


N/A
18 Years
N/A
Not Enrolling
Both
Malignant Mast Cell Tumors, Solid Organ Sites

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Trial Information

Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter: Confirmatory Validation of QASICC Questionnaire


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

QASICC questionnaire's 27 items tested on 990 patients to confirm the internal structure

Outcome Description:

Items quality Dimensional structure Dimensional consistence Measure accuracy Measure reliability Sensitivity to change

Outcome Time Frame:

30 days (+/- 7 days) after CVC implantation

Safety Issue:

No

Principal Investigator

PIERRE YVES MARCY, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2011-A01063-38

NCT ID:

NCT01616537

Start Date:

November 2011

Completion Date:

December 2013

Related Keywords:

  • Malignant Mast Cell Tumors
  • Solid Organ Sites
  • solid tumors
  • hematological malignancy
  • Mast-Cell Sarcoma
  • Mastocytosis
  • Mastocytoma

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