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

February 26, 2019 updated by: Marco Scarpa, Istituto Oncologico Veneto IRCCS

Totally Implantable Venous Access Devices (TIVAD): Impact on 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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Padova, Italy, 35128
        • Veneto Institute of Oncology IOV-IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • not neoplastic patients
  • psychopathological diagnosis
  • language misunderstanding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
  • 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)
No Intervention: standard care
this arm does not receive psychological support before and after Totally Implantable Venous Access Devices positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with care
Time Frame: 15 days
EORTC (European Organization for Research and Treatment of Cancer) questionnaire: QLQ C30 (Quality of Life Questionnaire)
15 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generic and quality of life and body image
Time Frame: 15 days
textual analysis of discoursive modalities used by patient in self-description
15 days
Generic and quality of life and body image
Time Frame: 15 days
EORTC questionnaire: IN-PATSAT32 (patient satisfaction questionnaire)
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • BI-PORT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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