Radiation TherapyNCT06132295
Adoption of Multiple Strategies to Reduce the Rate of Marker Detachment During Radiotherapy in Patients With Cancer
A study testing Nursing care in people with Radiation Therapy and Cancer Patients, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Therapy, Cancer Patients, Tattooing
- What is being tested?
- Nursing care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants with clear consciousness.
- participants could understand and comprehend Mandarin Chinese.
Who cannot join
- participants with impaired consciousness or decreased cognitive abilities.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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 :
- 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.
- 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.
- Hypoallergenic Adhesive Patches: Investigators offered a variety of hypoallergenic adhesive patches, catering to the skin characteristics of individual participants.
- 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.
- 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.
- 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.
- Conditions
- Radiation Therapy, Cancer Patients, Tattooing
- Being tested
- Nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing careOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Nursing care | Experimental | 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 Receives: Other: Nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of times the surface marks disappeared or faded
The number of times the surface marks disappeared or faded during treatment was recorded on the day the participants immediately after the radiotherapy.
Measured: The day the participants immediately after the radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132295
- Sponsor's protocol ID
- 2023-A-037
- Status last verified
- Jul 2023
- First submitted
- 7 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoption of Multiple Strategies to Reduce the Rate of Marker Detachment During Radiotherapy in Patients With Cancer
- ClinicalTrials.gov ID
- NCT06132295
- Acronym / sponsor ID
- 2023-A-037
- Conditions
- Radiation Therapy, Cancer Patients, Tattooing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 :
- 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.
- 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.
- Hypoallergenic Adhesive Patches: Investigators offered a variety of hypoallergenic adhesive patches, catering to the skin characteristics of individual participants.
- 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.
- 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.
- 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing care | Experimental | Other: Nursing careInvestigators 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- participants with clear consciousness.
- participants could understand and comprehend Mandarin Chinese.
Key exclusion criteria (1 listed)
- participants with impaired consciousness or decreased cognitive abilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing care1. 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. | Other | Nursing care |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing care in people with Radiation Therapy and Cancer Patients, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of times the surface marks disappeared or faded (time frame: The day the participants immediately after the radiotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.