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

NCT02075580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2019-02-27

No results posted yet for this study

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.

Conditions

  • Neoplasms Undergoing Chemotherapy

Interventions

BEHAVIORAL

psychological support (interactive/cognitive strategies)

* 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)

Sponsors & Collaborators

  • Fondazione Guido Berlucchi

    collaborator OTHER
  • Istituto Oncologico Veneto IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2018-09-30
Completion
2018-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02075580 on ClinicalTrials.gov