Evaluating Illustrated Vs. Traditional Pamphlets for Enhancing Self-Care in Radiation Therapy Patients

Not Applicable

Completed

• Conditions: Radiation Therapy; Head Neck Cancer; Breast Cancer Invasive

• Registration Number: NCT06678204
• Lead Sponsor: Chung Shan Medical University

Brief Summary

This quasi-experimental study utilized a pre- and post-test design with experimental and control groups to assess the effectiveness of optimized illustrated educational pamphlets in enhancing patient self-care cognition, satisfaction, and reducing anxiety. The experimental group received pamphlets with a combination of images and highlighted text, while the control group received traditional text-based pamphlets. The study targeted patients undergoing radiation therapy (RT) for head and neck or breast cancer for the first time. Pre-tests assessed baseline self-care cognition, and post-tests were conducted two weeks after treatment completion. The primary objective was to improve patient awareness and understanding of self-care, aiming to support both mental and physical well-being during RT.

Detailed Description

This quasi-experimental, pre- and post-test comparison study was conducted from November 2, 2023, to August 31, 2024, at a medical center in Central Taiwan, following Institutional Review Board approval (IRB No. CS2-23058). A total of 200 first-time RT patients with head and neck or breast cancer were enrolled and randomized into two groups of 100 patients each. The experimental group received optimized illustrated pamphlets covering essential RT information, common side effects, and self-care principles, while the control group received traditional text-based pamphlets.

Study Timeline

• Study Start: 2023-11-02
• Status Verified: 2024-08
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• participants with clear consciousness.
• participants could understand and comprehend Mandarin Chinese.

Exclusion Criteria

• participants with impaired consciousness or decreased cognitive abilities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Self-Care Cognition	Pre-test administered before treatment and post-test two weeks after treatment completion.	Description: Assesses patients' knowledge of radiation therapy self-care, including treatment regimen, side effects, and principles.; Tool: Self-Care Knowledge Questionnaire (SCKQ), scored on a 0-10 scale. Higher scores indicate greater self-care knowledge.
Satisfaction with Educational Materials	Post-test administered two weeks after treatment completion.	Description: Measures patient satisfaction with the educational materials (illustrated vs. text), with a focus on clarity and usefulness.; Tool: Patient Satisfaction Scale (PSS), scored on a 0-5 scale. Higher scores indicate greater satisfaction.
Anxiety Assessment	Pre-test administered before treatment and post-test two weeks after treatment completion.	Description: Evaluates patient anxiety related to radiation therapy, using the Hamilton Anxiety Rating Scale (HAMA).; Tool: Hamilton Anxiety Rating Scale (HAMA), scored on a 0-56 scale. Higher scores indicate higher anxiety.

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan