Malignant Mast Cell TumorsQASICC-EVANCT01616537
Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter
A study testing QUALITY OF LIFE QUESTIONNAIRE in people with Malignant Mast Cell Tumors and Solid Organ Sites, run by Centre Antoine Lacassagne at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Mast Cell Tumors, Solid Organ Sites
- What is being tested?
- QUALITY OF LIFE QUESTIONNAIRE
- How many people
- 990 participants
- Where
- 10 sitesFrance
- Study dates
- Nov 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Centre Paul Papin - Ico
Angers, 49933
Centre Francois Baclesse
Caen, 14076
Chu La Timone
Marseille, 13000
Chu de Montpellier
Montpellier, 34295
Centre Antoine Lacassagne
Nice, 06189
Institut Jean Godinot
Reims, 51056
Centre Rene Huguenin
Saint-Cloud, 92210
Centre Paul Strauss
Strasbourg, 67065
Institut Claudius Regaud
Toulouse, 31052
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Malignant Mast Cell Tumors, Solid Organ Sites
- Being tested
- QUALITY OF LIFE QUESTIONNAIRE
- Keywords
- solid tumors, hematological malignancy
- Medical subject headings
- Mast-Cell Sarcoma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUALITY OF LIFE QUESTIONNAIREOther
Also called QASICC, EORTC QLQ-C30
QASICC AND EORTC QLQ-C30 ADMINISTRATION 30 DAYS AFTER CVC IMPLANTATION
What is being measured
The primary outcome is the main question the study is designed to answer.
QASICC questionnaire's 27 items tested on 990 patients to confirm the internal structure
- Items quality
- Dimensional structure
- Dimensional consistence
- Measure accuracy
- Measure reliability
- Sensitivity to change
Measured: 30 days (+/- 7 days) after CVC implantation
Secondary outcomes (1)
Questionnaire's 27 items tested on 990 patients to confirm QASICC external structure: convergent-divergent validity compared to EORTC-QLQC30 questionnaire.
convergent-divergent validity of the QASICC questionnaire compared to EORTC-QLQC30 questionnaire
Measured: 30 days (+/-7 days) after CVC implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Mast Cell TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 990 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PIERRE YVES MARCY, MD, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616537
- Sponsor's protocol ID
- 2011-A01063-38
- Acronym
- QASICC-EVA
- Status last verified
- Feb 2013
- First submitted
- 7 Jun 2012
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter: Confirmatory Validation of QASICC Questionnaire
- ClinicalTrials.gov ID
- NCT01616537
- Acronym / sponsor ID
- QASICC-EVA / 2011-A01063-38
- Conditions
- Malignant Mast Cell Tumors, Solid Organ Sites
- Keywords
- solid tumors, hematological malignancy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 990 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QUALITY OF LIFE QUESTIONNAIREAlso: QASICC, EORTC QLQ-C30QASICC AND EORTC QLQ-C30 ADMINISTRATION 30 DAYS AFTER CVC IMPLANTATION | Other | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
Related trials for Malignant Mast Cell Tumors
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Active, not recruitingPhase 2
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
Acute Biphenotypic Leukemia, Acute Leukemia
RecruitingPhase 2
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN)
Not yet recruitingPhase 2
Depletion of CD45RA Positive Naive T Cells for the Prevention of Graft Versus Host Disease in Older Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Acute Leukemia or Myelodysplastic Syndrome
Acute Biphenotypic Leukemia, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PIERRE YVES MARCY, MD principal investigator
Centre Antoine Lacassagne
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QUALITY OF LIFE QUESTIONNAIRE in people with Malignant Mast Cell Tumors and Solid Organ Sites, run by Centre Antoine Lacassagne at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QASICC questionnaire's 27 items tested on 990 patients to confirm the internal structure (time frame: 30 days (+/- 7 days) after CVC implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015; AzTrials last refreshed its copy on 8 Nov 2026.