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

• Sponsor: Chung Shan Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06132295
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 33.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Radiation Therapy; Cancer Patients; Tattooing	Other: Nursing care	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Adoption of Multiple Strategies to Reduce the Rate of Marker Detachment During Radiotherapy in Patients With Cancer
• Actual Study Start Date: Jan 1, 2023
• Actual Primary Completion Date: Jun 30, 2023
• Actual Study Completion Date: Jun 30, 2023

Arms and Interventions

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; Consistent Schedule for the Replacement of Positioning Line Pens Tailored Educational Content Hypoallergenic Adhesive Patches Enriched Treatment Care Platform 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. Individual interventions, educational pamphlets prepared in-house were added, to assess the maintenance status of the positioning marks.

Outcome Measures

Primary Outcome Measures

1. The number of times the surface marks disappeared or faded [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chung Shan Medical University	Taichung City	Taiwan (r.o.c.)	Taiwan	408025

Sponsors and Collaborators

• Chung Shan Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chung Shan Medical University
• ClinicalTrials.gov Identifier: NCT06132295
• Other Study ID Numbers: 2023-A-037
• First Posted: Nov 15, 2023
• Last Update Posted: Nov 15, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 15, 2023