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| Name | Class |
|---|---|
| Fondazione Guido Berlucchi | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| standard care | No Intervention | this arm does not receive psychological support before and after Totally Implantable Venous Access Devices positioning |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| psychological support (interactive/cognitive strategies) | Behavioral |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Generic and quality of life and body image | textual analysis of discoursive modalities used by patient in self-description | 15 days |
| Generic and quality of life and body image | EORTC questionnaire: IN-PATSAT32 (patient satisfaction questionnaire) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veneto Institute of Oncology IOV-IRCCS | Padova | 35128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34867586 | Derived | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004347 | Drug Interactions |
| ID | Term |
|---|---|
| D000069437 | Pharmacological Phenomena |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
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| 15 days |