NCT06900179

Brief Summary

Malignant fungating wounds (MFWs) affect 5-14% of patients with advanced cancer, making them a common complication in this population. Characterized by symptoms such as foul odor, heavy exudate, bleeding, moderate to severe pain, and infection, MFWs cause significant physical discomfort and pose life-threatening risks while also leading to profound psychosocial issues, including shame and social isolation. These factors severely impact patients' quality of life, with half of those diagnosed surviving only six months on average. However, clinical nursing staff often lack adequate knowledge and skills in managing MFWs, with an average accuracy rate of just 56.5%. Notable deficiencies exist in areas such as wound disinfection, odor control, and wound assessment, directly affecting the quality of patient care and highlighting an urgent need for specialized MFW training. Traditional MFW education often lacks real-life clinical scenarios and hands-on practice, resulting in a gap between learning and application and leaving learners ill-prepared for the complexities of clinical settings. In contrast, augmented reality (AR) technology presents new possibilities for nursing education. AR can create highly simulated clinical environments where learners can safely practice complex clinical skills, enhancing clinical decision-making abilities. The implementation of AR-based training programs provides nursing staff with a more realistic and effective learning experience, allowing them to better address the challenges posed by MFWs and ultimately contributing to improvements in patient care and quality of life.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress82%
Aug 2024Oct 2026

Study Start

First participant enrolled

August 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

December 31, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

December 24, 2024

Last Update Submit

December 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • MFWs care Knowledge scale

    1\. \*\*MFWs Care Knowledge Scale\*\* This study will assess MFWs care knowledge using the \*\*MFWs Care Knowledge Scale\*\*. The scale ranges from \*\*0 to 100\*\*, with higher scores indicating \*\*better\*\* knowledge levels. The assessment will be conducted at \*\*baseline and post-intervention\*\* to measure changes in MFWs care knowledge over time.

    6months

Secondary Outcomes (1)

  • Clinical Reasoning Scale

    6months

Study Arms (2)

Augmented Reality

EXPERIMENTAL

Participants in the experimental group will receive an introduction to updated malignant fungating wound (MFWs) care guidelines and clinical applications, covering essential topics such as evidence-based wound management techniques, odor control, exudate handling, bleeding prevention, and pain management. Training will also address the identification and management of common MFWs-related complications, including infection. Additionally, participants will utilize the "MFWs with AR" program, engaging in simulated scenarios to enhance clinical reasoning and decision-making skills.

Other: MFWs with AR

Classroom Teaching

PLACEBO COMPARATOR

Classroom Teaching and Case Sharing Introduction to Updated MFWs Care Guidelines and Clinical Applications MFWs Wound Care Management of Common MFWs-Related Complications

Other: Classroom Teaching

Interventions

MFWs with AR This study utilized MyWeb AR as the primary development platform to create an AR-enhanced teaching curriculum for malignant fungating wound (MFW) care. Based on the 2022 Clinical Care Guidelines for Malignant Fungating Wounds and expert input from oncology specialists, the content covers key aspects of MFW care, including wound assessment, symptom identification, and care principles such as odor control, exudate management, and infection prevention. The program uses 3D object elements and animations to create interactive AR scenarios, allowing participants to engage in simulated clinical decision-making and care management, thereby enhancing their skills in a safe and controlled environment.

Augmented Reality

Classroom Teaching and Case Sharing Introduction to Updated MFWs Care Guidelines and Clinical Applications MFWs Wound Care Management of Common MFWs-Related Complications Case Sharing on MFWs Complication Management: Researchers

Classroom Teaching

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Full-time nursing staff working in oncology wards at a teaching hospital in northern Taiwan
  • Individuals willing to participate in the study and who have signed the informed consent form

You may not qualify if:

  • Nursing staff not assigned to oncology-related wards
  • Individuals expected to be unable to complete full participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MacKay Memorial Hosital

New Taipei City, New Taipei City, 251404, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2024

First Posted

March 28, 2025

Study Start

August 1, 2024

Primary Completion

March 12, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

December 31, 2025

Record last verified: 2025-02

Locations