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Totally Implantable Venous Access Devices: Quality of Life and Body Image

Not Applicable
Completed
Conditions
Neoplasms Undergoing Chemotherapy
Interventions
Behavioral: psychological support (interactive/cognitive strategies)
Registration Number
NCT02075580
Lead Sponsor
Istituto Oncologico Veneto IRCCS
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
128
Inclusion Criteria
  • neoplastic patients
  • adults
  • not visible demolitive interventions
  • not psychopathological diagnosis
  • language understanding
Exclusion Criteria
  • not neoplastic patients
  • psychopathological diagnosis
  • language misunderstanding

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
psychological supportpsychological support (interactive/cognitive strategies)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
Primary Outcome Measures
NameTimeMethod
Generic and quality of life and body image15 days

EORTC (European Organization for Research and Treatment of Cancer) questionnaire:

BR23 (Breast questionnaire, used just for BI scale, that is Body Image items)

Secondary Outcome Measures
NameTimeMethod
Satisfaction with care15 days

EORTC (European Organization for Research and Treatment of Cancer) questionnaire: QLQ C30 (Quality of Life Questionnaire)

Trial Locations

Locations (1)

Veneto Institute of Oncology IOV-IRCCS

🇮🇹

Padova, Italy

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