Totally Implantable Venous Access Devices: Quality of Life and Body Image
NCT ID: NCT02075580
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2013-09-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
psychological support (interactive/cognitive strategies)
* cognitive/behavioural intervention (6 times starting from hospital admission, in 90 days; for arm of intervention)
* metacognitive techniques (6 times starting from hospital admission, in 90 days; for arm of intervention)
* psychoeducational intervention (6 times starting from hospital admission; for arm of intervention)
* questionnaires: EORTC questionnaires and a written structured interview (3 times: hospital admission,15 days after surgical intervention, 90 days after intervention; in both arms)
standard care
this arm does not receive psychological support before and after Totally Implantable Venous Access Devices positioning
No interventions assigned to this group
Interventions
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psychological support (interactive/cognitive strategies)
* cognitive/behavioural intervention (6 times starting from hospital admission, in 90 days; for arm of intervention)
* metacognitive techniques (6 times starting from hospital admission, in 90 days; for arm of intervention)
* psychoeducational intervention (6 times starting from hospital admission; for arm of intervention)
* questionnaires: EORTC questionnaires and a written structured interview (3 times: hospital admission,15 days after surgical intervention, 90 days after intervention; in both arms)
Eligibility Criteria
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Inclusion Criteria
* adults
* not visible demolitive interventions
* not psychopathological diagnosis
* language understanding
Exclusion Criteria
* psychopathological diagnosis
* language misunderstanding
18 Years
80 Years
ALL
No
Sponsors
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Istituto Oncologico Veneto IRCCS
OTHER
Fondazione Guido Berlucchi
OTHER
Responsible Party
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Marco Scarpa
MD, PhD
Locations
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Veneto Institute of Oncology IOV-IRCCS
Padua, , Italy
Countries
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References
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Pinto E, Granziera E, Cagol M, Cappellato S, Alfieri R, Mari V, Meroni M, Zagonel V, Conte P, Pilati P, Castoro C, Cavallin F, Scarpa M. Totally Implantable Venous Access Devices: A Randomized Controlled Trial on the Effect of Psychological Support on Quality of Life and Body Image (BI-PORT). Front Psychol. 2021 Nov 12;12:703497. doi: 10.3389/fpsyg.2021.703497. eCollection 2021.
Other Identifiers
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BI-PORT
Identifier Type: -
Identifier Source: org_study_id
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