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

Primary Purpose

Consent Form, Lung Cancer, Colon Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
EDUCATION
Sponsored by
Cyprus University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Consent Form

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eleni Papoui

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EDUCATION

NON-INTERVENTION

Arm Description

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.

The difference in this group is that it will not be explained or given a form of educational intervention for management of rash.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 15, 2019
Last Updated
July 29, 2020
Sponsor
Cyprus University of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03992664
Brief Title
Education Intervention in Patients With Rash Due to Epidermal Growth Factor Receptor (EGFR) Treatment.
Acronym
EGFR
Official Title
Effectiveness of Educational Intervention for Patients That Receive Treatment With EGFRI
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyprus University of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Consent Form, Lung Cancer, Colon Cancer, Pancreas Cancer, Head and Neck Cancer, Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EDUCATION
Arm Type
Experimental
Arm Description
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.
Arm Title
NON-INTERVENTION
Arm Type
No Intervention
Arm Description
The difference in this group is that it will not be explained or given a form of educational intervention for management of rash.
Intervention Type
Other
Intervention Name(s)
EDUCATION
Other Intervention Name(s)
TRAINING PRAGRAMM
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Evaluation of the quality of life of all patients through the SF 36 questionnaire
Description
The SF 36 questionnaire will be given to every patient from the first time of the meeting. The questionnaire will be given every week.
Time Frame
4 weeks
Title
Assessing the quality of life in relation to the rash through the QLQI questionnaire.
Description
The QLQI questionnaire will be given in every patient from the second meeting because the questionnaire concerns questions about last week.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANDREAS CHARALAMBOUS, PhD
Organizational Affiliation
Cyprus University of Technology
Official's Role
Study Director
Facility Information:
Facility Name
Eleni Papoui
City
Larnaca
State/Province
Athienou
ZIP/Postal Code
7600
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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