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Clinical Trials/NCT06678204
NCT06678204CompletedNot Applicable

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

Chung Shan Medical University1 site in 1 country200 target enrollmentStarted: November 2, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Locations
1
Primary Endpoint
Self-Care Cognition

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •participants with impaired consciousness or decreased cognitive abilities.

Arms & Interventions

Optimized illustrated pamphlets

Experimental

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.

Intervention: Optimized illustrated pamphlets (Other)

Outcomes

Primary Outcomes

Self-Care Cognition

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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