- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02075580
Totally Implantable Venous Access Devices: Quality of Life and Body Image (BI-PORT)
February 26, 2019 updated by: Marco Scarpa, Istituto Oncologico Veneto IRCCS
Totally Implantable Venous Access Devices (TIVAD): Impact on Quality of Life and Body Image
Our hypothesis is that totally Implantable Venous Access Devices in neoplastic patients modify body image and self-representation.
Therefore, the purpose of this study is to evaluate the efficacy of psychological intervention on patients undergone this surgical practice.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
128
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
-
-
-
Padova, Italy, 35128
- Veneto Institute of Oncology IOV-IRCCS
-
-
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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- neoplastic patients
- adults
- not visible demolitive interventions
- not psychopathological diagnosis
- language understanding
Exclusion Criteria:
- not neoplastic patients
- psychopathological diagnosis
- language misunderstanding
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: psychological support
Arm A will undergo psychological support and standard care prior and post TIVAD (Totally Implantable Venous Access Devices) insertion Arm B will undergo standard care prior and post TIVAD insertion
|
|
No Intervention: standard care
this arm does not receive psychological support before and after Totally Implantable Venous Access Devices positioning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generic and quality of life and body image
Time Frame: 15 days
|
EORTC (European Organization for Research and Treatment of Cancer) questionnaire: BR23 (Breast questionnaire, used just for BI scale, that is Body Image items) |
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with care
Time Frame: 15 days
|
EORTC (European Organization for Research and Treatment of Cancer) questionnaire: QLQ C30 (Quality of Life Questionnaire)
|
15 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generic and quality of life and body image
Time Frame: 15 days
|
textual analysis of discoursive modalities used by patient in self-description
|
15 days
|
Generic and quality of life and body image
Time Frame: 15 days
|
EORTC questionnaire: IN-PATSAT32 (patient satisfaction questionnaire)
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2013
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
February 5, 2014
First Submitted That Met QC Criteria
February 26, 2014
First Posted (Estimate)
March 3, 2014
Study Record Updates
Last Update Posted (Actual)
February 27, 2019
Last Update Submitted That Met QC Criteria
February 26, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- BI-PORT
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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