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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02075580

Acronym

BI-PORT

Enrollment

128

Registered

2014-03-03

Start date

2013-09-30

Completion date

2018-12-31

Last updated

2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms Undergoing Chemotherapy

Keywords

cancer, quality of life, body-image, subcutaneous-implant

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.

Interventions

BEHAVIORALpsychological 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Generic and quality of life and body image	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

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

Other

Measure	Time frame	Description
Generic and quality of life and body image	15 days	textual analysis of discoursive modalities used by patient in self-description

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026