Clinical trial · Interventional
Totally Implantable Venous Access Devices: Quality of Life and Body Image
Totally Implantable Venous Access Devices (TIVAD): Impact on Quality of Life and Body Image
NCT02075580CI-TRIAL-00037341BI-PORTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms Undergoing Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| psychological support (interactive/cognitive strategies) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- psychological support
- description
- 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
- interventionNames
- Behavioral: psychological support (interactive/cognitive strategies)
- type
- NO_INTERVENTION
- label
- standard care
- description
- this arm does not receive psychological support before and after Totally Implantable Venous Access Devices positioning
Primary outcomes (1)
- measure
- Generic and quality of life and body image
- timeFrame
- 15 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * neoplastic patients * adults * not visible demolitive interventions * not psychopathological diagnosis * language understanding Exclusion Criteria: * not neoplastic patients * psychopathological diagnosis * language misunderstanding
References
Publications (1)
- DERIVEDPinto 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. PMID 34867586