Totally Implantable Venous Access Devices: Quality of Life and Body Image (BI-PORT)

Istituto Oncologico Veneto IRCCS

Status: Completed

Conditions: Neoplasms Undergoing Chemotherapy

Treatments: Behavioral: psychological support (interactive/cognitive strategies)

Study type: Interventional

Funder types: Other

Identifiers

NCT02075580

BI-PORT

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• neoplastic patients
• adults
• not visible demolitive interventions
• not psychopathological diagnosis
• language understanding

Exclusion criteria

• not neoplastic patients
• psychopathological diagnosis
• language misunderstanding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

psychological support

Experimental group

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

Treatment:

Behavioral: psychological support (interactive/cognitive strategies)

standard care

No Intervention group

Description:

this arm does not receive psychological support before and after Totally Implantable Venous Access Devices positioning