NCT06678204

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
Last Updated

November 7, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

October 29, 2024

Last Update Submit

November 5, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

Study Arms (1)

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.

Other: Optimized illustrated pamphlets

Interventions

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.

Optimized illustrated pamphlets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • participants with impaired consciousness or decreased cognitive abilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2024

First Posted

November 7, 2024

Study Start

November 2, 2023

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

November 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations