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

Neoplasms Undergoing Chemotherapy Clinical Trial

— BI-PORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075580
• Other study ID #: BI-PORT
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: Istituto Oncologico Veneto IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• neoplastic patients

• adults

• not visible demolitive interventions

• not psychopathological diagnosis

• language understanding

Exclusion Criteria:

• not neoplastic patients

• psychopathological diagnosis

• language misunderstanding

Related Conditions & MeSH terms

• Neoplasms Undergoing Chemotherapy

Intervention

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)

Locations

Country	Name	City	State
Italy	Veneto Institute of Oncology IOV-IRCCS	Padova

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Oncologico Veneto IRCCS	Fondazione Guido Berlucchi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Generic and quality of life and body image	textual analysis of discoursive modalities used by patient in self-description	15 days
Other	Generic and quality of life and body image	EORTC questionnaire: IN-PATSAT32 (patient satisfaction questionnaire)	15 days
Primary	Generic and quality of life and body image	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	Satisfaction with care	EORTC (European Organization for Research and Treatment of Cancer) questionnaire: QLQ C30 (Quality of Life Questionnaire)	15 days