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Completed

NCT Number: NCT02075580

Totally Implantable Venous Access Devices: 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.

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Key information

Conditions

Neoplasms Undergoing Chemotherapy Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veneto Institute of Oncology IOV-IRCCS

Padova, 35128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • not neoplastic patients
  • psychopathological diagnosis
  • language misunderstanding

Treatment and study plan

psychological support (interactive/cognitive strategies)

Behavioral
  • 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)

Primary outcomes

  1. 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)

Secondary outcomes

  1. Satisfaction with care

    Time frame: 15 days

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

Other outcomes

  1. Generic and quality of life and body image

    Time frame: 15 days

    textual analysis of discoursive modalities used by patient in self-description

  2. Generic and quality of life and body image

    Time frame: 15 days

    EORTC questionnaire: IN-PATSAT32 (patient satisfaction questionnaire)

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Collaborators

  • Fondazione Guido Berlucchi

Registry information

Official study title

Totally Implantable Venous Access Devices (TIVAD): Impact on Quality of Life and Body Image

Acronym: BI-PORT

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2014
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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