Adoption of Multiple Strategies to Reduce the Rate of Marker Detachment During Radiotherapy in Patients With Cancer

November 13, 2023 updated by: Chung Shan Medical University
Investigators used in-house-designed radiotherapy red and green light markers to distinguish individual measures after the provision of the initial nursing care to participants, added a homemade health education leaflet to collect data via actual observation, and counted the disappearance or fading of participants' body markers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From January 1, 2023 to June 30, 2023, a total of 200 participants were enrolled and undergoing radiation therapy. Inclusion Criteria: clear consciousness who could understand and comprehend Mandarin Chinese. Exclusion Criteria: patients with impaired consciousness or decreased cognitive abilities.

Investigators proposed a set of strategic initiatives :

  1. Consistent Schedule for the Replacement of Positioning Line Pens: Consistent Schedule for the Replacement of Positioning Line Pens: Investigators recommend implementing a standardized replacement schedule for positioning line pens, with replacement performed after every 50 uses.
  2. Tailored Educational Content: Investigators created personalized educational content tailored to each patient's educational background. This approach ensures that participants can easily understand their treatment plan.
  3. Hypoallergenic Adhesive Patches: Investigators offered a variety of hypoallergenic adhesive patches, catering to the skin characteristics of individual participants.
  4. Enriched Treatment Care Platform: Investigators commitment extended to creating a comprehensive treatment care platform, which provided guidance on positioning line usage, interactive community features, and practical information.
  5. Participants with BMI > 25 and an education level of high school or below, without specific caregivers, were identified by placing a red dot on the treatment record and on the patient's happiness card. Patients with BMI < 25 and an education level of high school or above, with specific caregivers, were identified by placing a green dot on their records.
  6. After implementing the red-green light differentiation for radiation therapy and individual interventions, educational pamphlets prepared in-house were added, to assess the maintenance status of the positioning marks.

The number of times the surface marks disappeared or faded during treatment was recorded on the day the participants completed treatment.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan (r.o.c.)
      • Taichung City, Taiwan (r.o.c.), Taiwan, 408025
        • Chung Shan Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nursing care
Investigators used in-house-designed radiotherapy red and green light markers to distinguish individual measures after the provision of the initial nursing care to participants, added a homemade health education leaflet to collect data via actual observation, and counted the disappearance or fading of participants' body markers
Other: Nursing care
  1. Consistent Schedule for the Replacement of Positioning Line Pens
  2. Tailored Educational Content
  3. Hypoallergenic Adhesive Patches
  4. Enriched Treatment Care Platform
  5. Participants with BMI > 25 and an education level of high school or below, without specific caregivers, were identified by placing a red dot on the treatment record and on the patient's happiness card. Patients with BMI < 25 and an education level of high school or above, with specific caregivers, were identified by placing a green dot on their records.
  6. Individual interventions, educational pamphlets prepared in-house were added, to assess the maintenance status of the positioning marks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of times the surface marks disappeared or faded
Time Frame: The day the participants immediately after the radiotherapy.
The number of times the surface marks disappeared or faded during treatment was recorded on the day the participants immediately after the radiotherapy.
The day the participants immediately after the radiotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-A-037

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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