NCT02075580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

5 years

First QC Date

February 5, 2014

Last Update Submit

February 26, 2019

Conditions

Neoplasms Undergoing Chemotherapy

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Satisfaction with care

    15 days

Other Outcomes (2)

  • Generic and quality of life and body image

    15 days

  • Generic and quality of life and body image

    15 days

Study Arms (2)

psychological support

EXPERIMENTAL

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

Behavioral: psychological support (interactive/cognitive strategies)

standard care

NO INTERVENTION

this arm does not receive psychological support before and after Totally Implantable Venous Access Devices positioning

Interventions

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)

psychological support

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • not neoplastic patients
  • psychopathological diagnosis
  • language misunderstanding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veneto Institute of Oncology IOV-IRCCS

Padua, 35128, Italy

Location

Related Publications (1)

  • Pinto E, Granziera E, Cagol M, Cappellato S, Alfieri R, Mari V, Meroni M, Zagonel V, Conte P, Pilati P, Castoro C, Cavallin F, Scarpa M. Totally Implantable Venous Access Devices: A Randomized Controlled Trial on the Effect of Psychological Support on Quality of Life and Body Image (BI-PORT). Front Psychol. 2021 Nov 12;12:703497. doi: 10.3389/fpsyg.2021.703497. eCollection 2021.

    PMID: 34867586DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Drug Interactions

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 5, 2014

First Posted

March 3, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

IT(1)