Effects of a 3D-Printed Port-A Catheter Model Training Course

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417294
• Other study ID #: FJUH112278
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Fu Jen Catholic University
• Contact: Ke-Yun Chao, PhD
• Phone: +886905301879
• Email: C00152[@]mail.fjuh.fju.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Admitted to the hematology and oncology ward of Fu Jen Catholic University Hospital

• Have Chinese communication skills

Exclusion Criteria:

• Refused to participate in the study.

Related Conditions & MeSH terms

• Cancer
• Patient Satisfaction

Intervention

Other:
• 3D health education model
explanation combined with 3D printed health education model
• traditional education
Regular education

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital, Fu Jen Catholic University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient education effectiveness questionnaire	higher scores mean a better outcome	immediately after the intervention