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

Enhancing Self-care Strategies in Radiation Therapy Patients Through Diverse Smart and Flipped Education Compared to Traditional Text Booklets

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.

Study Overview

• Status: Completed
• Conditions: Head Neck Cancer; Radiation Therapy; Breast Cancer Invasive
• Intervention / Treatment: Other: Optimized illustrated pamphlets

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• participants with impaired consciousness or decreased cognitive abilities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Optimized illustrated pamphlets; Participants in the experimental group received optimized illustrated educational pamphlets designed to enhance understanding of self-care during radiation therapy (RT). These pamphlets included images with key text highlights tailored for better cognitive retention. Pretests were administered before the start of treatment, and posttests were conducted two weeks after the completion of RT.

Other: Optimized illustrated pamphlets; Participants in the control group received traditional text-based pamphlets covering similar self-care information for RT. Pretests were administered before the start of treatment, and posttests were conducted two weeks after the completion of RT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Care Cognition	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.	Pre-test administered before treatment and post-test two weeks after treatment completion.
Satisfaction with Educational Materials	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.	Post-test administered two weeks after treatment completion.
Anxiety Assessment	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.	Pre-test administered before treatment and post-test two weeks after treatment completion.

Collaborators and Investigators

• Sponsor: Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 2024-A-037 (Other Grant/Funding Number: Chung Shan Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No