## Protocol Section
### Identification Module
**NCT ID:** NCT06417294

**Brief Title:** Effects of a 3D-Printed Port-A Catheter Model Training Course

**Official Title:** Effects of a 3D-Printed Port-A Catheter Model Training Course for Patient Discharge Instruction

#### Organization Study ID Info
**ID:** FJUH112278
#### Organization
**Class:** OTHER
**Full Name:** Fu Jen Catholic University
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fu Jen Catholic University

#### Responsible Party

**Investigator Affiliation:** Fu Jen Catholic University

**Investigator Full Name:** Ke-Yun, Chao

**Investigator Title:** Group leader of Respiratory Therapists

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to improve the knowledge and self-care skills of patients and primary caregivers regarding Port-A catheter placement through patient education.

**Detailed Description:** Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. The study aims to assess the impact of patient discharge education on their knowledge and satisfaction regarding catheter care.

Methods： This study focuses on patient education and evaluating its effectiveness. It employs a prospective randomized controlled trial with a cross-sectional design and parallel groups. The participants are divided into the 3D model group (experimental group) and the conventional education group (control group). A total of 120 subjects from the hematology-oncology ward are included in the study. The participants are randomly assigned to either the experimental group (60 participants) or the control group (60 participants) based on the month of admission, following a cluster randomization approach.

Effect： The investigator anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in patient discharge education.

### Conditions Module

**Conditions:**

- Patient Satisfaction

- Cancer

**Keywords:**

- 3D printed model

- port-a catheter

- discharge education

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Received a explanation combined with 3D medical education model

**Intervention Names:**

- Other: 3D health education model

**Label:** 3D model group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Received a regular education

**Intervention Names:**

- Other: traditional education

**Label:** traditional education group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 3D model group

**Description:** explanation combined with 3D health education model

**Name:** 3D health education model

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- traditional education group

**Description:** Regular education

**Name:** traditional education

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** higher means a better outcome

**Measure:** Patient education effectiveness questionnaire

**Time Frame:** immediately after the intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Admitted to the hematology and oncology ward of Fu Jen Catholic University Hospital
* Placed port-A catheter for the first time
* Have Chinese communication skills

Exclusion Criteria:

* Was not placing port-A for the first time.
* Refused to participate in the study.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** C00152@mail.fjuh.fju.edu.tw

**Name:** Ke-Yun Chao, PhD

**Phone:** +886905301879

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New Taipei City

**Country:** Taiwan

**Facility:** Fu Jen Catholic University Hospital, Fu Jen Catholic University

**Zip:** 24352

#### Overall Officials

**Official 1:**

**Affiliation:** Fu Jen Catholic University Hospital

**Name:** Ke-Yun Chao, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
