A Pilot Randomized Controlled Study on the Effects of an Educational Training Program on Skin Reactions Induced by Chemotherapies, Epidermal Growth Factor Inhibitors (EGFRI) Treatments, and Immunotherapies.
Sponsor study identifier
interventional
40
1 country
1
Study Start
January 1, 2019
Actual (reported)Primary Completion
December 12, 2020
Actual (reported)Study Completion
August 10, 2022
Actual (reported)The main adverse reaction of EGFR seen in patients is rash. EGFR treated patients have a 24-95% incidence of rash depending on the type of treatment they receive. Skin toxicity may occur in more than 80% of patients treated with cetuximab. If a severe rash (Grade 3 or 4) occurs, a dose reduction or discontinuation of treatment may be required. Also, infections are the main secondary side effect caused by the rash. The aim of the study is through a randomized clinical trial feasibility study to investigate the effectiveness of an educational intervention in patients receiving EGFRI therapy. It will be randomly selected which patients will belong to the intervention group and who in the control group. The type of program involves educational intervention.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 10, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)June 15, 2019
Actual (reported)June 20, 2019
Actual (reported)December 12, 2020
Actual (reported)August 10, 2022
Actual (reported)Skin grades
Repeated measurements were taken weekly regarding the grade of rash, pruritus and photosensitivity.
4 weeks
Functional health and wellbeing status
4 weeks
The patients in the experimental group follow the educational program once weekly, for 4 weeks.
The usual information was provided to them
The training program will focus on four parameters: cleanliness, hydration, protection from external stimuli, and finally early detection of skin side effects. The re-evaluation of the skin as well as the repetition of the questionnaires will be done every week for 4 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Eleni Papoui
Larnaca, ATHIENOU, 7600, Cyprus
ANDREAS CHARALAMBOUS, PhD
Cyprus University of Technology
40 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2019
First Posted
June 20, 2019
Study Start
January 1, 2019
Actual (reported)Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.
Primary Completion
December 12, 2020
Actual (reported)Study Completion
August 10, 2022
Actual (reported)Last Updated
February 13, 2025
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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