Education Intervention in Patients With Rash Due to Epidermal Growth Factor Receptor (EGFR) Treatment.

Study Overview
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Brief Summary
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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.

Detailed Description
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In recent years, EGFRI (Epidermal Growth Factor Receptor Inhibitor) have evolved as effective anti-cancer drugs. They are distinguished in monoclonal antibodies (cetuximab and panitumumab) and EGFR (TKIs) kinase inhibitors gefitinib, erlotinib and lapatinib, where they are used in the treatment of colon, rectal, head and neck, lung, pancreas and of breast. According to studies, the usual treatment for the prevention and treatment of skin rash refers to the use of antibiotics such as doxycycline, tetracycline and cortisone products such as hydrocortisone. It is also recommended to use moisturizing cream. The study of Carmine P. et al., 2011 mentions the need to investigate educational measures for the rash due to EGFR treatment.

Official Title
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Effectiveness of Educational Intervention for Patients That Receive Treatment With EGFRI

Conditions
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Consent Form, Lung Cancer, Colon Cancer, Pancreas Cancer, Head and Neck Cancer, Breast Cancer

Intervention / Treatment
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* Other: EDUCATION


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who take EGFR therapy for the first time. Classify at 0 or 1 according to WHO performance status. Exclusion Criteria: Patients with previous exposure to EGFR treatment. People already suffering from rash. People already suffering with other dermatological problems, eg psoriasis. People already taking part in any other study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDUCATION<br>If the patient is in the experimental team, questionnaires and printed education information will be given first and after the completion of the forms, the intervention will be followed. | Other: EDUCATION<br>* 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.<br>* Other names: TRAINING PRAGRAMM;|
| No Intervention: NON-INTERVENTION<br>The difference in this group is that it will not be explained or given a form of educational intervention for management of rash. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Through a randomized feasibility clinical trial to investigate the effectiveness of an educational intervention in conjunction with routine management of rash in patients receiving EGFRI therapy. | Identify the degree of rash using the NCI-CTCAE criteria. the degree of rash will compare in the experimental group (education) and in the non-experimental group (no education). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the quality of life of all patients through the SF 36 questionnaire | The SF 36 questionnaire will be given to every patient from the first time of the meeting. The questionnaire will be given every week. | 4 weeks | 
| Assessing the quality of life in relation to the rash through the QLQI questionnaire. | The QLQI questionnaire will be given in every patient from the second meeting because the questionnaire concerns questions about last week. | 3 weeks |