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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neoplasms Undergoing Chemotherapy

Intervention / Treatment
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* Behavioral: psychological support (interactive/cognitive strategies)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: neoplastic patients adults not visible demolitive interventions not psychopathological diagnosis language understanding Exclusion Criteria: not neoplastic patients psychopathological diagnosis language misunderstanding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, quality of life, body-image, subcutaneous-implant