TREATS: Telemedicine Rash Evaluation and Assessment of Toxicity in Skin in Acute Oncology and Haematology Care: A Pilot Study
Phase: NA
Conditions: Rash, Systemic Treatments, Tele-assessment
Sponsor: Sligo General Hospital

                                                 
 
 
1 
 
CLINICAL RESEARCH PROTOCOL 
__________________________________________________________________________ 
 
Study Title 
TREATS: Telemedicine Rash Evaluation and Assessment of Toxicity in Skin in Acute 
Oncology and Haematology Care: A Pilot Study 
 
 
Protocol Number: Version 3a 
Date: 17th Oct 2025 
__________________________________________________________________________ 
Protocol Authors 
Margaret Burke and Moira Maxwell 
__________________________________________________________________________ 
Principle Investigator 
Margaret Burke, Cancer Research Nurse, Sligo university Hospital, Ireland 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                                                 
 
 
2 
 
INVESTIGATOR PROTOCOL AGREEMENT PAGE 
 
I, the undersigned, am responsible for the conduct of the trial at this site and agree to the 
following: 
- 
I understand and will conduct the trial according to the protocol, any approved 
protocol amendments, ICH GCP and all applicable regulatory authority 
requirements and national laws. 
- 
I will not deviate from the protocol without prior written approval from the 
Institutional Review Board or Independent Ethics Committee, except where 
necessary to prevent any immediate danger to the subject. 
- 
I have sufficient time to properly conduct and complete the trial within the agreed 
trial period, and I have available an adequate number of qualified staff and 
adequate facilities for the foreseen duration of the trial to conduct the trial 
properly and safely. 
- 
I will ensure that any staff at my site(s) who are involved in the trial conduct are 
adequately trained regarding the protocol and their responsibilities.   
 
 
 
Signed  
 
 
 
 
 
     Date 
____________________________                                     _________________ 
 
Margaret Burke, Principal Investigator, Sligo University Hospital 
 
 
 
 
 
 
 

                                                 
 
 
3 
 
 
CO-INVESTIGATORS 
 
Christina Callaghan, Acute Haematology Oncology Nurse, Sligo University Hospital. 
Moira Maxwell, CNM2, Cancer Research Department, Sligo University Hospital. 
Dr Lore Komanyane, Consultant Medical Oncologist, Sligo University Hospital. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                                                 
 
 
4 
 
Contents 
1.  INTRODUCTION………………………………………………………………………………………6 
 
1.1 Background Information………………………………………….……………….6 
 
2.  STUDY RATIONALE………………………………………………………………………………….6 
 
3.  STUDY AIM……………………………………………………………………………..................6 
4. STUDY OBJECTIVES………………………………………………………………………………….7 
 
5. STUDY ENDPOINTS………………………………………………………………………………….7 
 
 
5.1 Primary Endpoint……………………………………………………………………..7 
5.2 Secondary Endpoint ……………………………………………………..…….……8 
 
6. STUDY DESIGN…………………………………………………………………………………………10 
7. STUDY POPULATION………………………………………………………………………………..10 
 
 
7.1 Participant Selection and Recruitment…………..………………………….10 
 
7.2 Study Inclusion Criteria………………………………………….………………….11 
 
 
7.3 Exclusion Criteria………………………………………………………………….……11 
8. WITHDRAWL FROM STUDY………………………………………………………….…………..11 
9. INFORMED CONSENT…………………………………………………………….….……………..11 
10. METHODOLOGY………………………………………………………………………..……………12 
 
10.1 Schedule of assessment……………………………………………………………12 
10.2.Data Collection Instrument Development………………………………..12 
11. INTERVENTION………………………………………………….……………………………………12  
12. ASSESSMENTS AND PROCEDURES.………………………………………………………….12 
13. STATISTICAL METHODS……………………………………………………………………………13 
13.1 Statistical Analysis Plan……………………………………………………………..15  
14. STUDY RISKS…………………………………………………………………………………………….16 
15. STUDY BENEFITS………………………………………………………………………………………16 
16. ADVERSE EVENT REPORTING……………………………………………………………………16 
 
 
16.1 Monitoring and Detection…………………………………………….17 
16.2 
Documentation 
of 
Adverse 
Events…………………………………………………………………………………..17  
 
16.3 Reporting of Adverse Events…………………………………………18 

                                                 
 
 
5 
 
16.4 AE/SAE Follow-up and Management……………………………..18  
17. ETHICS AND REGULATORY CONSIDERATIONS……………………………………………18 
18. DATA PROTECTION……………………………………………………………………………………18 
19. DATA HANDLING……………………………………………………………………………………….18 
19.1 Data Storage……………………………………………………………………………….18 
19.2 Data Processing…………………………………………………………………………..19  
19.3 Data Confidentiality………………………………………………………………..….19  
 
20. PUBLICATION OF STUDY FINDINGS AND USE OF 
INFORMATION………………………………………………………………………………………………..19 
21. INDEMNITY ………………………………………………………………………………………………19 
Appendix 1 Patient Information Leaflet and Informed Consent………………………20 
Appendix 2 Work Flow…………………………………………………………………………………….25 
Appendix 3 Escalation protocol……………………………………………………………………….26 
Appendix 4 UKNONS Skin Toxicity Assessment…………………………………………………27 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                                                 
 
 
6 
 
 
1. Introduction 
1.1. Background and Rationale 
Dermatological adverse events (AEs) or toxicities are a common and significant side effect of systemic 
anticancer therapies (SACT), including chemotherapy, targeted therapies and immunotherapy. These 
AEs affect the skin, hair, nails, and mucosa, manifesting as rashes, dryness, itching, and other changes 
that can severely impact patients' quality of life (QoL) and adherence to treatment protocols. 
Prevalence and Impact: Dermatological adverse events (AEs) occur frequently across various cancer 
treatments. For example, papulopustular eruptions are seen in up to 91% of patients treated with 
epidermal growth factor receptor inhibitors (EGFRis). These AEs can result in physical discomfort, 
altered body image, reduced self-esteem, social inhibition, and an increased risk of infection. In severe 
cases, dermatological AEs may necessitate dose reductions, treatment deferrals, or even 
discontinuation, which can compromise therapeutic outcomes. In 2024, skin toxicities accounted for 
4.7% of referrals for AHOS assessments at Sligo University Hospital (SUH), leading to significant and 
repeatable face-to-face consultations. These consultations required chair time in the hospital and also 
contributed to travel time and a potential financial burden for patients. 
Psychosocial Implications: Dermatological AEs also contribute significantly to emotional distress, 
including anxiety and depression. This form of "psychosocial toxicity" has been referred to as the "sixth 
vital sign" in cancer care. Quality of life (QoL) scales, such as the Dermatologic Life Quality Index and 
Skindex, highlight the profound impact these conditions can have on patients' daily lives and 
emotional well-being. 
Management Challenges: Early identification and effective management of dermatological AEs are 
essential for preserving patients' quality of life and ensuring uninterrupted cancer treatment. 
However, traditional in-person dermatological assessments are not always feasible due to logistical or 
geographical barriers, which presents a significant challenge in delivering timely and appropriate care 
Role of Telemedicine:Attend Anywhere is a secure, web-based platform utilised by the HSE that 
enables remote video consultations for clinical assessments, including skin toxicities. It improves 
patient access, reduces travel, and streamlines clinic flow. The platform supports individual, urgent, 
and group consultations, making it suitable for both solo and multidisciplinary team use. 
Key features include shared virtual waiting areas, automatic patient arrival alerts, and the ability to 
transfer patients between virtual rooms. The system offers customisable patient-facing content, such 
as branded leaflets and messages in multiple languages. Post-consultation follow-up materials can be 
sent automatically. Training for healthcare professionals is mandatory before clinical use. Overall, 
Attend Anywhere supports timely, accessible, and high-quality virtual care 
 
2. 
STUDY RATIONALE: 
Given the high prevalence of dermatological AEs and their impact on treatment adherence and patient 
well-being, developing effective telemedicine protocols for skin toxicities  is crucial. This approach 
could improve access to dermatological care, enable early intervention, and ultimately enhance 
patient outcomes in oncology settings. 

                                                 
 
 
7 
 
3. 
STUDY AIM:  
Evaluate the effectiveness of telemedicine as alternative to traditional in person clinical review, in 
diagnosing and managing skin toxicities in acute oncology/haematology patients using existing UKONS 
guidelines. 
4. 
STUDY OBJECTIVES 
4.1  
Primary Objective 
To evaluate the clinical effectiveness of telemedicine consultations, compared with traditional 
in-person review, in diagnosing and managing dermatological toxicities in acute oncology and 
haematology patients in accordance with United Kingdom Oncology Nursing Society (UKONS) 
guidelines. 
 
4.2  
Secondary Objectives 
To assess patient satisfaction with the telemedicine intervention. 
To evaluate healthcare provider satisfaction with telemedicine consultations. 
To assess the feasibility of implementing telemedicine within acute oncology and 
haematology services. 
To identify potential barriers to implementation of telemedicine in this clinical context. 
 
5. 
STUDY ENDPOINT 
5.1  
Primary Endpoint 
 Clinical Resolution of Skin Toxicity (Non-Inferiority Endpoint) 
Definition: 
Proportion of patients achieving complete resolution or downgrade to Grade 0–1 skin toxicity within 
6 weeks of initial assessment. 
Comparison: 
 
Prospective 
telemedicine 
cohort 
(Attend 
Anywhere) 
vs 
 
Retrospective 2024 in-person AHOS cohort (n=56) 
Non-Inferiority 
Margin: 
Pre-specified absolute margin (e.g., −10%) to demonstrate telemedicine is not clinically inferior to 
face-to-face care. 
Measurement 
Standard: 
Grading performed using United Kingdom Oncology Nursing Society (UKONS) standardised toxicity 
assessment. 

                                                 
 
 
8 
 
Analysis: 
Difference in proportions with 95% CI; non-inferiority concluded if lower bound does not cross margin. 
 
5.2  
Secondary Endpoints 
Time-to-Clinical Resolution 
Definition: 
Number of days from first AHOS contact to documented resolution (Grade 0–1). 
Comparison: 
Telemedicine vs retrospective in-person cohort. 
Analysis: 
Kaplan–Meier time-to-event analysis or median time comparison. 
 
Escalation to In-Person Review 
Prospective Cohort Only 
Definition: 
Proportion of telemedicine patients requiring: 
 
Conversion to face-to-face review 
 
Emergency department attendance 
 
Hospital admission 
This is a safety endpoint, ensuring remote triage is clinically appropriate. 
 
Treatment Modification Rate 
Definition: 
Proportion of patients requiring: 
 
SACT dose reduction 
 
Treatment delay 
 
Treatment interruption 
Comparison between cohorts to assess impact of telemedicine on oncologic management. 
 
Unscheduled Acute Oncology Contacts 
Definition: 
Number of unplanned re-contacts with AHOS within 6 weeks. 

                                                 
 
 
9 
 
Comparison between telemedicine and retrospective face-to-face care. 
 
Patient-Reported Endpoints (Prospective Only) 
Quality of Life (QoL) 
Instrument: 
QLQ administered: 
 
Post initial assessment 
 
At resolution or week 6 
Endpoint Measures: 
 
Change in QoL score from baseline to resolution/week 6 
 
Mean QoL score at 6 weeks 
 
Patient Satisfaction 
Definition: 
Mean satisfaction score following telemedicine consultation. 
Secondary 
Measure: 
Proportion rating telemedicine as acceptable/preferable to in-person review. 
 
Feasibility Endpoints (Prospective Only) 
Uptake Rate 
Proportion of eligible patients who: 
 
Accept telemedicine 
 
Decline telemedicine 
 
Safety Endpoints 
1. Incidence of toxicity progression from Grade ≤2 to Grade ≥3 
2. Adverse clinical outcomes attributable to delayed assessment 
3. Hospital admission related to dermatologic toxicity 
 
6. 
STUDY DESIGN 
This study will use an interventional prospective pilot study using  quasi-experimental design. 

                                                 
 
 
10 
 
Duration: 6 months. 
 
7. 
STUDY POPULATION  
7.1 
 Participant Selection and Recruitment 
Participant will be used from 2 cohorts 
 
A prospective telemedicine cohort 
 
A retrospective comparator cohort (2024 in-person AHOS patients, n=56) 
Prospective Cohort (Telemedicine Arm) 
Participants will be recruited using convenience sampling from patients accessing the Acute 
Haematology/Oncology Service (AHOS) with suspected skin toxicity secondary to systemic anti-cancer 
therapy (SACT). 
At first point of contact (patient-initiated telephone call to AHOS), patients requiring visual 
dermatologic assessment will be offered review via the Attend Anywhere telemedicine platform. 
If patients express interest: 
 
Written study information will be sent via SMS. 
 
An individualised Attend Anywhere link will be issued. 
 
Study-related data will be collected following consultation. 
Patients declining telemedicine will receive standard face-to-face review but will not be included in 
the prospective study cohort. 
Participants will undergo assessment and management according to United Kingdom Oncology 
Nursing Society (UKONS) standard of care guidelines. 
Remote follow-up will occur weekly for up to 6 weeks or until toxicity resolution. 
 
Retrospective Comparator Cohort 
A retrospective review of medical records from 2024 (n=56 patients) will be undertaken. These 
patients accessed AHOS via traditional in-person consultation for SACT-related skin toxicities. 
Data collected will include: 
 
Toxicity grade 
 
Management interventions 
 
Time to resolution 
 
Escalation rates 
 
Treatment modifications 

                                                 
 
 
11 
 
This cohort will serve as the comparator group for non-inferiority analysis. 
Setting: Acute oncology/haematology nursing service within Saolta University Health Care Group. 
 
7.2  
Study Inclusion Criteria 
Participants must meet all of the following criteria: 
 
Oncology or haematology patients receiving systemic anti-cancer therapy (SACT). 
 
Presentation with new skin toxicity recognised as a known adverse effect of the administered 
SACT. 
 
Skin toxicity graded ≤ Grade 2 according to UKONS assessment criteria. 
 
Clinical stability not requiring immediate in-person review. 
 
Access to a smartphone or computer with internet capability sufficient to support 
telemedicine consultation. 
 
7.3  
Study Exclusion Criteria 
Participants will be excluded if any of the following apply: 
 
Skin toxicity graded ≥ Grade 3. 
 
Requirement for urgent or immediate in-person clinical assessment. 
 
Presentation of unexpected or atypical dermatologic toxicity not consistent with known SACT-
related adverse effects. 
 
Inability to access or use required telemedicine technology. 
8.  
WITHDRAWL FROM STUDY 
Participants will be informed of their right to refuse to participate and their right to withdraw 
from this research study 
 
9.  
INFORMED CONSENT 
Informed consent to take part in the research will be obtained.  Patients will be consented by 
a member of the study team. Participants will be given the opportunity to take their time 
between receiving the PIL and agreeing to participate in the study.   
Informed consent Pathway- 
1 
Patient contact made for assessment to AHOS 
2 
Study explained, offered participation to study, verbal consent obtained. 

                                                 
 
 
12 
 
3 
Written information sent electronically ie SMS with explicit I consent to participate in study  
discussion upon clicking the link for assessment 
4 
Link sent for Attend Anywhere 
 
10  
METHODOLOGY 
10.1 
Schedule of assessments 
Data Collection Instrument Baseline 
End 
of 
treatment 
Consent And Demographics 
 
DLQI 
 
 
Telemedicine Effectiveness 
 
 
Patient Satisfaction 
 
 
Quality Of Care 
 
 
10.2. 
Data Collection Instrument Development 
Patient experience and service utility were evaluated using a hybrid assessment framework 
comprising the validated Telemedicine Satisfaction Questionnaire (TSQ) and a study-specific Tele-
Toxicity Service Evaluation Tool. The 14-item TSQ (Yip et al., 2003) was utilized to measure three core 
domains: Quality of Care, Similarity to Face-to-Face Encounters, and Perception of Interaction, using 
a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree.' To supplement these 
validated metrics, a secondary service evaluation tool was developed to capture domain-specific 
operational data, including technical performance (e.g., image upload success), perceived benefits 
(e.g., avoided travel and faster access to specialist care), and specific barriers to remote skin toxicity 
assessment. This dual-instrument approach ensures a comprehensive evaluation of both the 
psychological acceptability of the telemedicine platform and its practical efficacy in the management 
of Systemic Anti-Cancer Therapy (SACT) toxicities. All quantitative survey data will be cross-referenced 
with clinical outcomes, including time-to-resolution and SACT dose modifications, to identify 
correlations between patient-reported satisfaction and objective clinical recovery. 
 Impact on patient well-being was evaluated using the Dermatology Life Quality Index (DLQI), a 
validated 10-item questionnaire designed to measure the health-related quality of life in patients 
suffering from skin diseases (Finlay & Khan, 1994). The DLQI assesses six primary domains: symptoms 
and feelings, daily activities, leisure, work and school, personal relationships, and treatment burden. 
Each item is scored on a 4-point Likert scale (0 = 'not at all' to 3 = 'very much'), with a total score 
ranging from 0 to 30; higher scores indicate a greater impairment in quality of life. For the purposes 
of this study, DLQI scores were collected at the point of toxicity onset and again at the 6-week follow-
up (or upon resolution). This longitudinal data allows for the calculation of the 'Minimal Clinically 
Important Difference' (MCID), enabling the research team to correlate improvements in the Kaplan-

                                                 
 
 
13 
 
Meier resolution curve with a quantifiable reduction in the psychosocial burden of SACT-induced skin 
toxicities. 
 
11. 
INTERVENTION 
Implementation of the telemedicine platform Attend Anywhere to assess and manage skin toxicity, 
following the UK Oncology Nursing Society (UKONS) standard of care guidelines. Currently, these 
guidelines are applied in face-to-face consultations for this patient group.  
 
12. 
ASSESSMENT AND PROCEEDURES 
Point of contact- the patient in the community rings the AHOS in the usual manner to discuss 
symptoms of dermatology toxicity secondary to SACT. 
1st contact assessment indicates visual assessment required. 
AHOS offers telemedicine assessment via Attend Anywhere. 
If interested provide written information to patient via text. 
If the patient is willing to proceed the Attend Anywhere individualised link will be sent to the patient.  
If not interested, patient will be reviewed in traditional face to face manner as appropriate. 
Patient is assessed using SOC UKONS assessment. SEE APPENDIX 
QLQ sent via SMS post assessment 1. 
Weekly remote monitoring for 6 weeks or until resolution. Treated per standard of care (SOC) and 
repeat assessment using Access Anywhere. 
QLQ via SMS at resolution or week 6 of follow-up. 
 
Data Collection 
Clinical Outcomes: 
Diagnostic concordance  
Time to resolution or escalation of care. 
 
Patient Satisfaction: 
Standardized patient satisfaction and QLQ survey at 6 weeks using Redcap data collection tool. 
 
13.  
STATISTICAL METHODS 
Sample Size: 25 prspective patients  

                                                 
 
 
14 
 
13.1. 
Statistical Analysis Plan 

                                                 
 
 
15 
 
Primary Outcome: Time-to-Resolution (TTR) 
The primary clinical endpoint is the Time-to-Resolution (TTR), defined as the interval (in days) from 
the onset of SACT-induced skin toxicity to the documented return to Grade 0 or the patient's baseline 
skin health. 
 
Method: TTR will be analyzed using Kaplan-Meier (KM) survival estimates. 
 
Censoring: Patients who do not achieve resolution within the 6-week (42-day) observation 
window, those who withdraw from the study, or those who experience a competing event 
(e.g., death or treatment cessation for non-toxicity reasons) will be right-censored at the date 
of their last assessment. 
 
Comparative Analysis: The Log-Rank (Mantel-Cox) test will be used to compare TTR curves 
stratified by key covariates: Initial Toxicity Grade (UKONS 1 vs. 2 vs. 3), SACT Type 
(Chemotherapy vs. Immunotherapy/Targeted), and Management Strategy (Topical vs. 
Systemic). 
 Secondary Outcome: Patient Satisfaction and Usability (TSQ & Service Evaluation) 
Patient-reported satisfaction and service utility will be assessed descriptively and analytically. 
 
Descriptive Statistics: For the Telemedicine Satisfaction Questionnaire (TSQ), mean scores and 
standard deviations will be calculated for each of the three domains (Quality of Care, Similarity 
to Face-to-Face, and Perception of Interaction). 
 
Benchmarking: A global TSQ mean score of $> 4.0$ (on the 5-point scale) will be predefined 
as "High Satisfaction." 
 
Service Evaluation: Categorical data from the custom survey (e.g., "Would you use again?", 
"Technical difficulties experienced") will be presented as frequencies and percentages. 
 Tertiary Outcome: Quality of Life (DLQI) 
The impact of skin toxicity on patient well-being will be evaluated using the Dermatology Life Quality 
Index (DLQI). 

                                                 
 
 
16 
 
 
Scoring: DLQI scores (0–30) will be categorized into clinical bands (e.g., 0–1 = No effect; 11–
20 = Very large effect). 
 
Longitudinal Analysis: A Paired t-test (or Wilcoxon Signed-Rank test for non-normal 
distributions) will be used to compare DLQI scores at onset versus 6-week follow-up to 
determine the magnitude of improvement following telemedicine intervention. 
Correlation and Multivariate Analysis 
To bridge the clinical and patient-reported data, the following inferential tests will be applied: 
 
Correlation: Spearman’s Rho ($\rho$) will be used to assess the correlation between the 
maximum DLQI score and the total Time-to-Resolution (TTR). 
 
Predictive Modeling: Multiple Logistic Regression will be employed to identify predictors of 
"Unscheduled AHOS Contacts." Independent variables will include Initial Toxicity Grade, DLQI 
score at onset, and the presence of technical difficulties (Service Evaluation). 
 
Significance Level: All statistical tests will be two-tailed, and a p-value of $< 0.05$ will be 
considered statistically significant. Analysis will be performed using SPSS 
14. STUDY RISKS 
Risks are minimal. There is a small risk that telemedicine assessment may miss a severe skin 
problem, but clear protocols are in place for escalation to in-person review if needed. 
15. STUDY BENEFITS 
Participants may benefit from more convenient and timely care, and the study may help 
improve future services for patients with skin toxicities. 
16. ADVERSE EVENT REPORTING 
An Adverse Event (AE) is any untoward medical occurrence in a participant that arises during 
the course of the study, regardless of whether it is considered related to the study 
intervention. 
A Serious Adverse Event (SAE) is defined as any AE that: 
 
Results in death 

                                                 
 
 
17 
 
 
Is life-threatening 
 
Requires inpatient hospitalisation or prolongation of existing hospitalisation 
 
Results in persistent or significant disability or incapacity 
 
Is a congenital anomaly/birth defect 
 
Is deemed medically significant by the investigator Adverse Events (AE) refers to any 
untoward event or medical occurrence that may not have a causal relationship with 
the treatment.  
 
16.1 Monitoring and Detection 
Participants will be provided with contact information for the study team and instructed 
to report any symptoms or concerns. Study staff will proactively inquire about potential 
adverse effects during scheduled check-ins.  Participants will be monitored through 
routine clinical care and follow-up appointments. 
16.2 Documentation of Adverse Events 
All adverse events must be documented in the patient’s medical records and recorded in 
the study Adverse Events Log, Appendix VIII, to include:  
 
Date and time of event onset 
 
Description of the event 
 
Severity (mild, moderate, severe) 
 
Assessment of relatedness to the study intervention (definitely, probably, possibly, 
unlikely, or unrelated) 
 
Action taken (e.g., medical treatment) 
 
Outcome and resolution date 
16.3 Reporting of Adverse Events 
 
Non-serious AEs: 
 
Logged in patient medical records and AE logs 

                                                 
 
 
18 
 
 
Reviewed during regular team meetings 
 
Reported in study summary at conclusion 
 
Serious Adverse Events 
 
Must be reported to the Principal Investigator and patients medical consultant within 
24 hours of awareness. 
 
Principal Investigator reports to the Research Ethics Committee (REC) within 7 
calendar days of awareness (for unexpected and related SAEs) 
 
Documentation medical records and AE log. 
 
16.4 AE/SAE Follow-up and Management 
All AEs will be followed until: 
 
The event resolves 
 
The participant returns to baseline health status 
 
A final outcome is established 
 
17. ETHICS AND REGULATORY CONSIDERATIONS 
Ethics approval has been obtained for this study from the ethics committee governing Sligo 
University Hospital.  All study procedures will be conducted in line with Good Clinical Practice 
Guidelines. 
18. DATA PROTECTION 
Explicit consent will be sought from participants for the processing of their data.  
Sligo University Hospital, HSE is both the data controller and data processor for this study.  
19. DATA HANDLING 
19.1 Data Storage 
Data will be retained for a period up to 5 years post completion of study and destroyed as 
per HSE policy. 

                                                 
 
 
19 
 
19.2 Data Processing 
All data collected is for the purpose of achieving the objective of this research study.  The 
data will not be processed in any way that will cause damage or distress to the participant. 
Once explicit consent has been obtained from participants their data will be 
pseudonymised by assigning a unique identifier to their data.  Only members of the 
research team will have access to the identifier key which will be locked in restricted office 
within Sligo University Hospital. 
All study documents and participant data will be stored in a locked and restricted office 
within Sligo University Hospital.  Only study team members will have access to the data.  
Data analysis will be completed on a HSE computer that is password protected, encrypted 
and cyber secure per the HSE IT security policy.  
19.3 Data Confidentiality 
All information regarding the study data or results supplied to the investigator is privileged 
and confidential information.  All research team members who have access to the data 
are bound to maintain confidentiality in line with their employment contract and 
professional conduct per their regulatory body. 
 
20. PUBLICATION OF STUDY FINDINGS AND USE OF INFORMATION  
Data associated with this study may be used in the context of scientific research and 
publications or educational material.  No participant will be identifiable from the data 
presented. 
21. INDEMNITY 
This study is registered with the Clinical Research Development Office and CIS cover obtained where 
applicable. 
  
 
 

                                                 
 
 
20 
 
 
Appendix 1 Patient information leaflet and consent 
 
Study title: TREATS: Telemedicine Rash Evaluation and Assessment of Toxicity in Skin in Acute 
Oncology and Haematology Care: A Pilot Study 
 
 
 
Principal investigator’s name: 
Margaret Burke 
Principal investigator’s title: 
Cancer Research Nurse 
 
Telephone number of principal investigator:  
086 0479985 
Consultant co-investigator’s name: 
Lore Komanyane 
 
Consultant co-investigator’s title:  
Consultant Oncologist 
 
Data Controller’s/joint Controller’s Identity:  
            
Health Service Executive  
Data Controller’s/joint Controller’s Contact Details: 
 
0719171111             
Data Protection Officer’s Identity:                                                Mr Liam Quirke  
Data Protection Officer’s Contact Details:                                
DPO @HSE west  
 
 
 
 
091 524222 
 
You are being invited to take part in a research study to be carried out at Sligo University 
Hospital by the Cancer Services department. 
Before you decide whether or not you wish to take part, you should read the information 
provided below carefully and, if you wish, discuss it with your family, friends or GP (doctor).  
Take time to ask questions – don’t feel rushed and don’t feel under pressure to make a quick 
decision. 
 
You should clearly understand the risks and benefits of taking part in this study so that you 
can make a decision that is right for you. This process is known as ‘Informed Consent’.  
 
You don't have to take part in this study. If you decide not to take part it won’t affect your 
future medical care. 
 
You can change your mind about taking part in the study any time you like.  Even if the study 
has started, you can still opt out.  You don't have to give us a reason.  If you do opt out, rest 
assured it won't affect the quality of treatment you get in the future. 
 
 

                                                 
 
 
21 
 
Why is this study being done? 
You are being invited to take part in a research study at Sligo University Hospital because you 
are 
receiving 
cancer 
treatment 
and 
have 
developed 
a 
skin 
problem. 
This study is being done to find out if video consultations (telemedicine) can be used to safely 
and effectively assess and manage skin problems caused by cancer treatments. Instead of 
always coming to the hospital for a face-to-face appointment, you may be able to use your 
smartphone or computer to show your skin to a nurse or doctor over a secure video call. We 
want to see if this is as good as a regular clinic visit, and whether patients and staff are happy 
with this new way of working. 
 
Who is organising and funding this study? 
This study is organised by Cancer Services and the Acute Oncology/Haematology Service at 
Sligo University Hospital. There is no external funding for this study; it is being carried out 
using existing hospital resources 
 
Why am I being asked to take part? 
You have been invited because you are a cancer patient under our care who has developed a 
skin problem during treatment. We aim to include about 25 patients in this study. 
 
How will the study be carried out? 
When you contact the Acute Oncology/Haematology Service with a skin problem, you may be 
offered a video consultation instead of an in-person visit. If you agree, you will receive a 
secure video link for your appointment. The nurse or doctor will assess your skin and 
recommend treatment. You may be asked to send a photo of your skin problem. As part of 
the study you will be asked to fill in a short questionnaire about your experience and quality 
of life. Your care will continue as usual, and you can still attend the hospital in person if 
needed. 
 
What will happen to me if I agree to take part? 
 
You will have a video call with a nurse or doctor to assess your skin problem. 
 
You may be asked to send a photo of your skin problem using your phone or computer. 
 
You will be asked to complete a satisfaction and quality of life questionnaire. 
 
Your care will not be affected by your decision to take part or not. 
 
You can withdraw at any time without giving a reason 
 
How long will the study take?   
You will be followed up weekly via video call until your skin problem has resolved as would 
be usual in a face to face setting. At 6 weeks (or before that if your problem has resolved) you 
will be asked again to complete a questionnaire about your experience of telemedicine 
assessments. 
 
Will I need to attend the hospital for extra visits? 
No extra hospital visits are planned as part of this study. If your skin problem needs to be seen 
in person, we will arrange a clinic appointment for you. 
 

                                                 
 
 
22 
 
Will researchers look at my medical records? 
Yes, the research team will review your medical records to confirm your diagnosis, treatment, 
and outcome of your skin problem in addition to your questionnaire responses. All 
information will be kept confidential. The AHOS nurse will have full access to your clinical 
information in order to best assess your needs. 
 
Video/and or Audio recordings? 
You may be asked to send a photo of your skin problem. These images will be stored securely 
and only used as part of your standard care.  They will form part of your medical record as 
they would if provided in the event of a routine face to face consultation and will not be 
evaluated as part of the research project. 
 
What other treatments are available to me? 
If you do not wish to proceed with a video assessment, the AHOS nurse will schedule an 
appointment for assessment in the usual manner. 
 
What are the benefits? 
You may benefit from faster and more convenient care. The study may help improve services 
for other patients with similar problems in the future. 
 
What are the risks? 
Risks are minimal. There is a small chance that a skin problem may not be fully assessed by 
video, but you will be offered an in-person appointment if needed. All information you 
provide will be kept confidential. 
 
What if something goes wrong when I’m taking part in this study? 
If you become upset or unwell during the study, please let the research team or the Acute 
Haematology Oncology Nurse know. If you have any concerns or complaints, you can contact 
the Principal Investigator or your usual care team. 
 
Will it cost me anything to take part? 
No. There are no costs for taking part, and you will not be paid for participation. 
 
Is the study confidential? 
You will join your consultation via a unique link, and it will be hosted in secure “virtual waiting 
rooms” accessible only to authorized persons. 
The video consultation will take place in a secure clinical area where there will be no other 
persons present for the duration of your consultation to ensure no inadvertent disclosures 
during the call. 
The consultation is not recorded by default however it should be noted that the consultation 
would not be recorded without your express consent to same.  
Any identifiable health information will not be stored on the video platform. 
All notes/photos taken as part of the consultation will be stored with the current hospital 
patient record. Questionnaires completed will be stored on a password protected database 

                                                 
 
 
23 
 
with a unique number to identify it and stored separate from your patient record in a secure 
office. 
Data Protection 
How will my information be used? 
We will use your personal information to help us study whether telemedicine is a good way 
to assess and manage skin problems in cancer patients. 
What is the legal basis for processing my data? 
We are processing your data for scientific research in the public interest, under Article 6(1)(e) 
and Article 9(2)(j) of the General Data Protection Regulation. 
Who will have access to my information? 
Only the research team at Sligo University Hospital will have access to your identifiable 
information. Any data used in reports or publications will be anonymised so you cannot be 
identified. 
How long will my information be kept? 
Your data will be kept securely for 5 years after the end of the study, after which it will be 
deleted or destroyed. 
What are the risks to my data? 
All reasonable steps will be taken to protect your information from loss or unauthorised 
access. In the unlikely event of a data breach, you will be informed and the breach will be 
reported to the Data Protection Commissioner. 
What are my rights? 
 
You have the right to withdraw your consent at any time. 
 
You have the right to ask for a copy of your data. 
 
You have the right to have your data corrected or deleted. 
 
You have the right to restrict or object to processing of your data. 
 
You have the right to make a complaint to the Data Protection Commissioner. 
How can I withdraw my consent? 
You can withdraw your consent at any time by contacting the Principal Investigator at the 
contact details above. This will not affect your care. 
Will my data be used for future research? 

                                                 
 
 
24 
 
Your data will only be used for this study unless you give separate permission for future use. 
If future use is planned, you will be asked for your consent. 
Where can I get further information? 
If you have any further questions about the study or if you want to opt out of the study, you 
can rest assured it won't affect the quality of treatment you get in the future.   
If you need any further information now or at any time in the future, please contact:  
Name : Chrissie Callaghan, AHOS Nurse Specialist. 
Address: Day Services Oncology Unit 
087 9932448 
 
PATIENT CONSENT FORM 
 
 
What do I do next? 
 
If you are not interested in participating in the study, please respond to this to indicate you 
would like an in person appointment which will be arranged for you in the usual manner. 
 
If you wish to proceed with the research using video call assessment and follow up please 
read the table below. 
  
1 
I have read and understood the Information Leaflet about this research project.  The 
information has been fully explained to me and I have been able to ask questions, all of 
which have been answered to my satisfaction. 
2 
I understand that I don’t have to take part in this study and that I can opt out at any time.  
I understand that I don’t have to give a reason for opting out and I understand that opting 
out won’t affect my future medical care. 
3 
I am aware of the potential risks, benefits and alternatives of this research study. 
4 
I give permission for researchers to look at my medical records to get information.  I have 
been assured that information about me will be kept private and confidential. 
5 
I have been given a copy of the Information Leaflet and this consent form will be held in 
my records. My consent will be recorded in the medical notes 
6 
I consent to take part in this research study having been fully informed of the risks, benefits 
and alternatives. 
7 
I give informed explicit consent to have my data processed as part of this research study.  
8 
I consent to be contacted by researchers as part of this research study. 
 
If you are satisfied and agree with all of the above statements and wish to participate in the 
study, please respond using the words ‘I consent’ and an appointment using video call will be 
arranged for you. 
 
 
 

                                                 
 
 
25 
 
Appendix 2 Work Flow  
 
 
 
 
 

                                                 
 
 
26 
 
Appendix 3 Escalation Protocol 
Escalation Protocol: SACT Skin 
Assessments via Telemedicine 
1. Urgent Clinical Indicators (Immediate Escalation) 
Escalate to urgent in-person review if the telemedicine assessment identifies: 
- Suspected UKONS grade > amber(Grade >2 skin toxicity per CTCAE v5.0), including: 
  - Painful or widespread rash 
  - Blistering, ulceration, desquamation 
  - Suspected Stevens-Johnson Syndrome or toxic epidermal necrolysis 
  - Infected lesions with systemic signs (e.g. fever, chills) 
- Rapid worsening of dermatologic symptoms since last assessment 
- Skin toxicity impacting performance status or treatment continuation 
 
Action: Immediate referral to acute oncology service for urgent face-to-face review. 
2. Moderate or Persistent Skin Toxicity (Planned Escalation) 
Escalate to non-urgent in-person review if: 
- Lesion or rash is not resolving with prescribed treatment 
- Diagnostic uncertainty (e.g. unclear whether rash is drug-related or infective) 
- Rash recurs despite previous intervention 
- Multiple concurrent toxicities affecting skin, mucosa, or nails 
 
Action: Book an acute oncology service for urgent face-to-face review. 
3. Patient Factors or Preference 
Escalate if: 
- Patient requests in-person review or expresses anxiety about appearance/progression 
- Patient has communication barriers (hearing, language, cognition) making remote assessment 
unreliable 
- Concerns arise about adherence, self-care, or need for hands-on support 
 
Action: Schedule face-to-face review. 
Workflow Summary for SACT Teledermatology Escalation 
Trigger 
Action 
Timeline 
UKONS grade >amber 
Urgent face-to-face via 
oncology team 
Same-day 
Persistent rash or unclear 
diagnosis 
Routine in-person review 
(OPD/clinic) 
Within 6 week 
Patient preference or 
communication need 
Face-to-face booked with 
appropriate clinician 
As appropriate 

                                                 
 
 
27 
 
Documentation & Patient Safety 
- All escalation decisions will be recorded in the oncology patient record  
Full UKONS assessment should be documented at each teleconsultation. 
- Patients will be given clear safety netting advice and contact details for the acute oncology line. 
 
 
Appendix 4 UKONS Skin Toxicity Assessments     
 

                                                 
 
 
28 
 
 

                                                 
 
 
29 
 

                                                 
 
 
30 
 
 

                                                 
 
 
31