Use of the Skin Cancer Quality of Life Impact Tool (SCQOLIT) - a Feasibility Study in Non-melanoma Skin Cancer
Phase: NA
Conditions: Skin Neoplasm, Squamous Cell Carcinoma, Basal Cell Carcinoma
Sponsor: Oxford University Hospitals NHS Trust

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Study Title:  Use of the Skin Cancer Quality of Life Impact Tool (SCQOLIT) – a feasibility study 
in non-melanoma skin cancer 
Internal Reference Number / Short title: Utility of the Skin Cancer Quality of Life Impact Tool 
OUHT PID Ethics Ref: 11054 
Date and Version No: 1st February 2015, V3.0 
Clinical Trials.gov: NCT02580916 
 
 
Chief Investigator: 
Dr Rubeta N H MATIN 
Post-CCT Medical Dermatology Fellow 
Dermatology Department, Churchill Hospital 
Old Road, Headington, Oxford, OX3 7LJ 
 
Co-Investigators:  
Elizabeth Gibbons, PROM group, Health Services Research Unit, Nuffield 
Department of Population Health, University of Oxford 
Sponsor:  
Oxford University Hospitals NHS Trust  
Funder: 
Oxfordshire Health Services Research Committee grant Reference 1127  
Chief Investigator Signature:  
 
 
No potential conflicts of interest to declare. 
 
 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, host organisation, and members of the Research Ethics Committee, 
unless authorised to do so. 
 

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TABLE OF CONTENTS 
1. 
SYNOPSIS .............................................................................................................................................. 4 
2. 
ABBREVIATIONS .................................................................................................................................... 4 
3. 
BACKGROUND AND RATIONALE ........................................................................................................... 5 
4. 
OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS .......................................................................... 7 
5. 
STUDY DESIGN ...................................................................................................................................... 7 
6. 
PARTICIPANT IDENTIFICATION .............................................................................................................. 9 
6.1. 
Study Participants ......................................................................................................................... 9 
6.2. 
Inclusion Criteria for Groups 1 – 3 ................................................................................................ 9 
6.3. 
Exclusion Criteria for Groups 1 – 3 ............................................................................................... 9 
7. 
STUDY PROCEDURES ........................................................................................................................... 10 
7.1. 
Recruitment ................................................................................................................................ 10 
7.2. 
Informed Consent ....................................................................................................................... 10 
7.3. 
Screening and Eligibility Assessment .......................................................................................... 12 
7.4. 
Subsequent Visits ........................................................................................................................ 12 
7.5. 
Discontinuation/Withdrawal of Participants from Study ........................................................... 13 
7.6. 
Definition of End of Study ........................................................................................................... 13 
8. 
STUDY DATA COLLECTION .................................................................................................................. 13 
9. 
STATISTICS AND ANALYSIS .................................................................................................................. 14 
9.1. 
Description of Statistical Methods .............................................................................................. 14 
9.2. 
The Number of Participants ........................................................................................................ 15 
9.3. 
Analysis of Outcome Measures/Endpoints ................................................................................. 15 
10. 
DATA MANAGEMENT ..................................................................................................................... 16 
10.1. 
Access to Data ......................................................................................................................... 16 
10.2. 
Data Recording and Record Keeping ...................................................................................... 16 
11. 
QUALITY ASSURANCE PROCEDURES ............................................................................................... 17 
12. 
ETHICAL AND REGULATORY CONSIDERATIONS .............................................................................. 17 
12.1. 
Declaration of Helsinki ............................................................................................................ 17 
12.2. 
ICH Guidelines for Good Clinical Practice ............................................................................... 17 
12.3. 
Approvals ................................................................................................................................ 17 
12.4. 
Reporting ................................................................................................................................ 17 
12.5. 
Participant Confidentiality ...................................................................................................... 17 
13. 
FINANCE AND INSURANCE .............................................................................................................. 18 
13.1. 
Funding ................................................................................................................................... 18 

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13.2. 
Insurance ................................................................................................................................ 18 
14. 
PUBLICATION POLICY ...................................................................................................................... 18 
15. 
REFERENCES .................................................................................................................................... 19 
16. 
APPENDIX A:  STUDY FLOW CHART FOR ALL PARTICIPANTS. ......................................................... 20 
17. 
APPENDIX B:  SCHEDULE OF STUDY PROCEDURES FOR GROUP 2 – CLINIC-BASED. ....................... 20 
18. 
APPENDIX C:  SCQOLIT TOOL Questionnaire. ................................................................................. 21 
19. 
Appendix D: EQ-5D Questionnaire ................................................................................................. 22 
20. 
Appendix E: AMENDMENT HISTORY ............................................................................................... 23 
 

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1. SYNOPSIS 
Study Title 
Use of the Skin Cancer Quality of Life Impact Tool (SCQOLIT) – a 
feasibility study in non-melanoma skin cancer 
Internal ref. no. / short 
title 
Feasibility and utility of the Skin Cancer Quality of Life Impact Tool 
Study Design 
Feasibility study 
Study Participants 
Patients with histological diagnosis of non-melanoma skin cancer 
Planned Sample Size 
300 patients 
Planned Study Period 
1 year 
 
Objectives 
Endpoints 
Primary 
 
To establish the acceptability of 
using the SCQOLIT tool as an 
assessment of patient reported 
outcome measures (PROMs) for 
patients with non-melanoma skin 
cancer (NMSC) attending 
dermatology clinics 
 
Mixed methods 
1) Analysis of 
a) Patient participation rates 
b) Questionnaire response 
rates 
c) Missing values 
2) Analysis of patient and staff 
preferences, views and experiences 
 
Secondary 
 
To determine the psychometric 
properties of the SCQOLIT as a 
tool for patients with NMSC 
 
Analysis of:  
a) Construct validity 
b) Responsiveness  
c) Clinically Important Difference 
d) Floor and ceiling effects 
e) Intra- and Inter-participant 
change scores 
 
 
2. ABBREVIATIONS 
 
BAD 
British Association of Dermatologists 
BCC 
Basal cell carcinoma 
CI 
Chief Investigator 
CRF 
Case Report Form 
CTRG 
Clinical Trials & Research Governance, University of Oxford 

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DCT 
Direct care team 
DLQI 
Dermatology Life Quality Index 
GCP 
Good Clinical Practice 
GP 
General Practitioner 
ICF 
Informed Consent Form 
ICH 
International Conference of Harmonisation 
MDT 
Multidisciplinary Team 
NHS 
National Health Service 
NMSC 
Non melanoma skin cancer 
NRES 
National Research Ethics Service 
OUH 
Oxford University Hospitals NHS Trust 
PI 
Principal Investigator 
PIS 
Participant Information Sheet 
PROM 
Patient reported outcome measure 
QOL 
Quality of life 
R&D 
NHS Trust R&D Department 
REC 
Research Ethics Committee 
SCC 
Squamous cell carcinoma 
SCQOLIT 
Skin Cancer Quality of Life Impact Tool 
SOP 
Standard Operating Procedure 
URN 
Unique reference number 
 
3. BACKGROUND AND RATIONALE 
 
Patient-reported outcome measures (PROMs) offer enormous potential to improve quality and results of 
Dermatology services, providing validated evidence of health from the patient perspective. They can 
assess levels of health needs in populations with skin disease, and over time, can provide evidence of 
outcomes of services for the purposes of audit, quality assurance and comparative performance 
evaluation. They may also improve the quality of interactions between clinicians and patients in the 
Dermatology clinic. Lord Darzi’s Interim Report on the future of the NHS recommended that PROMs 
should play a more significant role in our approach to clinical quality in the NHS (1). Using PROMs is 
recommended as a method to improve the experience of patients with cancer, and in prostate cancer 
has been demonstrated to uncover specific, previously unidentified, issues which were affecting a large 
number of people (2). This evidence is therefore essential to planning provision of appropriate 
monitoring and support services, including specialist psychological support services.  
 
In addition, PROMs data have the potential to impact on clinical decision-making and thus plausibly 
guide commissioning choices. As a result, PROMs have been assessed nationally since April 2009, for four 
elective surgical procedures (hip replacement, knee replacement, varicose vein and groin hernia surgery) 

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to determine whether and how commissioners and patients can best use this information to guide 
decisions about services and support options (3).  It therefore seems reasonable that in the future, 
PROMs could be extended to evaluate outcomes in other specialties including Dermatology, to support 
the commissioning process.  
 
Referrals of skin lesions (including suspected skin cancers) comprise 30 – 45% of specialist Dermatology 
outpatient work (4). This is likely to intensify, as skin cancer is the most rapidly increasing cancer among 
fair-skinned populations worldwide. In England, the incidence of and mortality from skin cancer are 
increasing each year, with current estimates in excess of 100 000 new cases of non-melanoma skin 
cancer (NMSC) per annum, although this is likely to be a gross underestimate due to incomplete 
reporting. NMSC are rarely life threatening, however, both disease and treatments can be associated 
with substantial morbidity and confer significant financial burden to the NHS.  Consequently, the British 
Association of Dermatologists commissioned the Patient-reported Outcomes Measurement Group, 
Oxford to review the evidence for PROMs for skin cancer (5). The authors concluded that there was a 
limited volume of published evidence for the application of generic PROMs (e.g. Dermatology Life Quality 
Index (DLQI)) in skin cancer. Cancer-specific quality of life (QOL) questionnaires appeared more sensitive 
than generic PROMs in capturing relevant QOL issues. In the NMSC population, these issues include 
scarring, disfigurement, anxiety and fear of future skin cancers (6,7). Although limited attempts have 
been made to develop PROMs specific to NMSC, the authors suggested that further evaluations are 
needed (5).  
 
One particular skin cancer-specific PROM that was evaluated in this review was the Skin Cancer Quality 
of Life Impact Tool (SCQOLIT) [Appendix C]. The SCQOLIT is a ten-item instrument developed specifically 
for patients with non-metastatic skin cancer. Item generation and reduction was undertaken using 100 
patients with both melanoma and non-melanoma skin cancers (6). Responses were obtained evaluating 
the impact of their skin cancer on these ten items using a 4-point Likert scale. All responses were totalled 
scores with a maximum achievable score of 30 (similar to the DLQI). The instrument was further 
evaluated with 54 patients with melanoma and 59 patients with NMSC. Reproducibility using intraclass 
correlation coefficients for both groups was reported to be greater than 0.72. Internal consistency 
(Cronbach’s alpha) for the NMSC group was 0.81. Convergent validity was supported by significant 
correlation of change of scores between SCQOLIT and the DLQI. The SCQOLIT demonstrated some 
sensitivity to change with statistically significant differences in scores from baseline to three months but 
this was not considered to be clinically significant (8). The authors of the commissioned review on 
PROMs for Patients with Skin Cancer (5) concluded that the SCQOLIT questionnaire demonstrated 
evidence in favour of reproducibility, validity, internal consistency but felt that it required further 
evaluation (6).   
 
The decision to evaluate the SCQOLIT in this study, includes its similarity in overall format and brevity to 
that of the DLQI which is a PROM now widely used in routine medical dermatology clinical practice, thus 
making it a good candidate for incorporation into busy skin cancer clinics. The SCQOLIT takes less than 
five minutes for the patient to complete and its similar score calculation to the DLQI, a PROM familiar to 
Dermatologists, means that this questionnaire incurs low administrative burden. Acceptability and 
feasibility of this tool has never been rigorously assessed in Dermatology clinics. Studies evaluating 
PROMs in NMSC have been largely assessed in relation to surgical treatments yet basal cell carcinoma 
can be effectively treated using medical treatments e.g. topical immunomodulators and photodynamic 
therapy, and to date, PROMs have not been investigated in these sub-populations.  
 

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Justification summary 
There are very few studies evaluating PROMs in skin cancer yet the incidence of all skin cancers is rapidly 
increasing and confers significant burden on NHS healthcare resources. The British Association of 
Dermatologists commissioned the Patient-Reported Outcome Measurement Group in Oxford to 
undertake a structured review of PROMs in skin cancer in 2013 (5), and the authors concluded that 
although limited attempts had been made to develop PROMs specific to NMSC, larger studies are 
needed to evaluate their use in clinical practice. This feasibility study is designed to evaluate one of the 
PROMs tools reviewed by the authors – the SCQOLIT questionnaire (8), and aims to establish its utility 
and impact in patients with non-melanoma skin cancers attending dermatology clinics. We will assess 
both patient and clinician acceptability of the SCQOLIT questionnaire tool for use in a busy skin cancer 
clinic. By determining the impact of using the SCQOLIT questionnaire on patients with NMSC, we hope to 
identify any unmet needs and potentially use these results to inform future clinical decisions and/or 
service planning.  
In the long-term, a validated NMSC-specific PROM would allow robust comparison of quality of care 
pathways from a patient perspective, across different specialties. In addition, it could help to standardize 
multi-centred randomized controlled trials for emerging treatments and more appropriately direct 
healthcare resources to improve quality of life in patients with NMSC. 
4. OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS 
Objectives 
Outcome Measures/Endpoints  
Primary Objective 
To establish the acceptability of using the 
SCQOLIT tool as an assessment of patient 
reported outcome measures (PROMs) for 
patients with non-melanoma skin cancer (NMSC) 
attending Dermatology clinics 
 
 
Mixed methods 
1) Analysis of 
a) Patient participation rates 
b) Questionnaire response rates 
c) Missing values 
2) Analysis of patient and staff preferences, 
views and experiences 
 
Secondary Objectives 
To determine psychometric properties of the 
SCQOLIT as a tool for patients with NMSC 
Analysis of:  
a) 
Construct validity 
b) 
Responsiveness  
c) 
Clinically Important Difference 
d) 
Floor and ceiling effects 
e) 
Intra- and Inter-participant change    
scores 
5. STUDY DESIGN 
 
Plan of Investigation 

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To undertake a prospective feasibility study investigating the utility and impact of the SCQOLIT tool in 
patients presenting with a new diagnosis of non-melanoma skin cancer.  
Participants: 
All patients referred to the Dermatology Tumour outpatient clinics in the Churchill Hospital, Oxford with 
a clinically suspected non-melanoma skin cancer (NMSC) will be considered for participation. Entry 
criteria will be as broad and inclusive as possible to increase external validity. Patients will be 
approached by the Chief Investigator (clinician who is part of the normal direct care team [DCT]) or other 
clinicians directly responsible for the patient’s care in the Dermatology clinic. Following obtaining 
consent to participate in the study, patients will be asked to complete between 2 and 3 questionnaires at 
2 – 3 time-points according to the study flowchart (Appendix A). 
 
Group 1 (Postal group) – these are patients who will be identified from the histological diagnosis of their 
skin cancer by members of the DCT and deemed ‘low risk’; questionnaires will be administered by post.  
Group 2 (Clinic-based) – these are patients who will be identified from the histological diagnosis of their 
skin cancer by members of the DCT, for whom all aspects of the study will be conducted in the 
Dermatology clinic. 
Participants will be invited to complete the SCQOLIT and EQ-5D (used for comparison purposes, given its 
widespread use in other healthcare contexts in the UK) questionnaires [Appendices C & D) at:  
a) baseline (after histological diagnosis of a NMSC is confirmed – both Groups) 
b) 3 months – either by postal (Group 1) or face-to-face (Group 2) dependent on whether the 
patient is returning to the Dermatology clinic for routine follow-up  
c) at 6-9 months in the dermatology clinic if the patient is deemed high risk (squamous cell 
carcinoma with high risk clinicopathological features as listed by the National British Association 
Dermatologists Multiprofessional Guidelines for management of SCC) (Group 2 only) (9) 
 
We aim to minimize any inconvenience to the patient and the study aims to evaluate the SCQOLIT as 
part of the patients’ routine clinical pathway as determined by their skin cancer subtype and in keeping 
with local and national guidelines for management (9).  
Demographic details (age, gender, Fitzpatrick skin type) and clinicopathological information (skin cancer 
type, histological subtype, site, tumour diameter, previous history of skin cancer, active current medical 
conditions, medication history) for all study participants will be recorded so this information can be 
correlated with the participant questionnaire scores. Subgroup analysis of scores will also be undertaken.  
Group 3 (Interviews): A Qualitative Researcher (Co-Investigator) will undertake structured interviews 
with approximately 20 patients from both Group 1 and 2. Potential participants will be invited to 
volunteer their contact details at the time of consent to the Questionnaire study. This is optional; they 
may refuse to do so and still take part in the main questionnaire study. The patient will then be 
contacted by the Qualitative Researcher (Co-Investigator) at a later date and subsequently consented for 
the interview. Consent can take place on the telephone (details provided in section 7.1) but this will be 

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confirmed face-to-face in written form when the patient attends the Dermatology department for the 
interview.  
Group 4 (Clinician focus group): As part of clinical governance arrangements, monthly Dermatology 
Departmental Clinical Governance meetings are held with staff (including Dermatology doctors, 
Dermatology nurses, Dermatology healthcare assistants and Skin Cancer Nurse Specialists) to discuss 
service improvement issues. Preliminary discussion on 15th July 2014 (approx. 20 attendees) confirmed 
engagement and willingness of the Dermatology clinical team to support the project. We aim to discuss 
the project at the end of the study period in the same setting, to establish staff perspectives on the 
study, to establish usefulness of the SCQOLIT tool and to identify any barriers to implementation. Staff 
will be provided with [PIS 4: Focus group] and invited to consent to the focus group work using Consent 
Form – Focus Group (Clinicians). 
Mixed methods will be used to evaluate the acceptability of the SCQOLIT tool as a process of PROM data 
collection in the Dermatology clinic (detailed in section 9). 
6. PARTICIPANT IDENTIFICATION 
6.1. Study Participants 
There will be four categories of participants, Groups 1 – 3 are participants with a new diagnosis of non-
melanoma skin cancer (primary or recurrent) on any site of the body: 
Group 1 (Postal) – this will include those patients with a ‘low risk’ NMSC as deemed by Oxford Skin 
Cancer Multidisciplinary Team guidelines  
Group 2 (Clinic-based) – this will include those patients with a ‘moderate to high risk’ NMSC as deemed 
by Oxford Skin Cancer Multidisciplinary Team guidelines 
Group 3 (Interview) – these will be volunteers selected from Groups 1 and 2.  
Group 4 (Focus Group : Clinicians) – this will include any Dermatology staff member who is involved in 
consenting and collecting PROMS data and has a role for direct care of patients attending Dermatology 
outpatient clinics.  
6.2. Inclusion Criteria for Groups 1 – 3 
• 
Male or Female, aged 18 years or above. 
• 
Participant is willing and able to give informed consent for participation in the study. 
• 
All patients with a histopathological diagnosis of NMSC (primary or recurrent disease) will be 
included.  
• 
All treatments used for NMSC will be included in the study; excision, shave excision, curettage 
and cautery, Mohs micrographic surgery, photodynamic therapy and topical treatments e.g. 
imiquimod cream.   
6.3. Exclusion Criteria for Groups 1 – 3  

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The participant may not enter the study if ANY of the following apply: 
• 
Concurrent internal malignancy as this is likely to significantly influence QOL.  
• 
Patients referred onwards to other specialties for management of their skin cancer e.g. Plastic 
surgeons / Clinical oncology.  
• 
Other significant dermatological diseases e.g. severe inflammatory or blistering skin conditions 
as this may influence QOL.  
• 
Inability to consent for themselves.  
7. STUDY PROCEDURES 
7.1. Recruitment 
 
Groups 1 & 2 
Patients referred to the Dermatology Department in the Churchill Hospital, Oxford, with a clinically 
suspected non-melanoma skin cancer will be identified by the Chief Investigator (who is a member of the 
direct care team) or other clinicians who are part of the direct care team, from the Dermatology Tumour 
outpatient clinics. At the time of their initial visit, eligible patients with a suspected skin cancer will be 
approached by a member of their direct care team (clinician or trained dermatology nurse) and provided 
with the relevant patient information leaflet (recruitment to Group 1 or 2).  
Group 3: Interviews 
Recruitment to Group 3 will be offered to all patients who consent to the Questionnaire study. They will 
be asked when they consent to this, if they agree to be contacted at a later date for an interview and will 
voluntarily provide their contact details on the [Contact Interview Form]. Their contact details will be 
collected by the Chief Investigator. Participants will be advised that only a selected sample of 20 
individuals will be contacted at a later date to be invited to interview and therefore they are unlikely to 
be contacted. Once the patient has a confirmed diagnosis of NMSC and is therefore eligible for inclusion 
in the study, the CI will pass their contact details to the Qualitative Researcher (Co-Investigator) who will 
contact selected participants at a later date. Patients who decline to participate may volunteer 
information about why they don’t want to take part, and this information (their reason for declining) will 
be recorded. 
Group 4: Focus Group (Clinicians) 
Clinicians who work in the Dermatology Department, have direct care responsibilities for patients with 
NMSC and who have been involved with the study will be invited to attend the Focus Group.  
7.2. Informed Consent 
Members of the direct care team (which includes the Chief Investigator) with appropriate training will 
discuss the study with the potential participant and take informed consent from participants who wish to 
join. This will take place in the Dermatology outpatient clinic.  

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All patients attending the Dermatology Tumour clinic are referred by their GP with a suspected skin 
cancer. All patients will therefore be approached and depending on their suspected type of skin cancer 
they will be offered one of two Patient Information Leaflets to keep:  
PIS: Group 1 (Postal group) – these are patients who are deemed clinically to have a ‘low risk’ NMSC.  
PIS: Group 2 (Clinic-based) – these are patients who are deemed clinically to have a ‘moderate to high 
risk’ NMSC. 
The participant will be allowed as much time as they wish to consider the information, and will be 
provided with the opportunity to question the Chief Investigator, other Dermatology clinical staff or 
other independent parties, to decide whether they will participate in the study. Participants will be given 
either PIS Group 1 or PIS Group 2 at the initial consultation to keep. The PIS details the exact nature of 
the study and what it will involve for the participant. There will be an opportunity to go through the PIS 
in detail with their clinician at the time of consenting. It will be clearly stated in the PIS that the 
participant is free to withdraw from the study at any time for any reason without prejudice to future 
care, and with no obligation to give a reason for withdrawal. 
Consent will be obtained subsequently when the patient attends for surgical intervention (part of routine 
clinical care). This can be between 3 hours after the initial consultation (small proportion of high risk 
patients offered surgery on the day if the service is available) to up to six weeks later (routine minor 
operation for basal cell carcinoma). All clinicians who are involved in the direct care of patients who 
attend with a suspected skin cancer, are both suitably qualified and experienced for this role and have 
had appropriate training. Written Informed Consent will then be obtained by means of participant dated 
signature and dated signature of the person who presented and obtained the Informed Consent. A copy 
of the signed Informed Consent form (Consent Form – Study) will be given to the participant.  
Group 3 (Interviews): The Qualitative Researcher (Co-Investigator) will undertake structured interviews 
with 20 patients randomly selected from both Groups 1 and 2. Patients will be invited to voluntarily 
provide their contact details at the time of initial consent to the main Questionnaire study using a 
separate ‘Contact Interview Form’. Patients will be advised at this time that they may not necessarily be 
contacted at a later date if they are not selected for the Interview study. The contact details of the 
patients will be stored by the CI and once patients are entered into the questionnaire study, their details 
will then be sent securely to the Qualitative Researcher. The randomly selected patients will 
subsequently be contacted by the Qualitative Researcher (Co-Investigator) who will invite patients to 
participate by posting the separate Patient Information Leaflet: Group 3 (Interviews) and consent form 
(Consent Form – Interviews) to them. Patients will be allowed sufficient time to review the PIS. They will 
be provided with the Qualitative Researcher’s contact details and the CI contact details on the PIS, if they 
have any queries.  The patient will be contacted by telephone by the Qualitative Researcher and a 
mutually agreed interview date will be arranged once the patient has consented verbally on the 
telephone. At the beginning of the face-to-face interview the Qualitative Researcher will confirm that the 
patient is happy to proceed and record written consent [Consent form – Interviews] to enter this part of 
the study. The patient will be offered the option to withdraw at this point if they decide to do so.  
Group 4 (Focus Group – Clinicians): Clinicians who work in the Dermatology Department, have direct 
care responsibilities for patients with NMSC and who have been involved with the study will be invited to 

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consent to a focus group and be provided with a PIS 4: Focus Group (Clinicians). This will take place as 
part of a monthly Dermatology Clinical Governance Meeting.  
7.3. Screening and Eligibility Assessment 
Participants will be identified from the Dermatology Tumour Clinics. These occur on a daily basis in the 
morning (Monday to Friday) with additional clinics on Wednesday and Thursday afternoons. Participants 
will be approached by the clinician at the initial consultation visit when they attend with a clinically 
suspected skin cancer. They will be provided with the relevant PIS according to risk of NMSC (assessed 
clinically as part of standard care). Once the participants have been provided with sufficient time to 
consider the study they will be consented to enter using ‘Consent Form – Questionnaire Study’. This can 
be between 3 hours and 6 weeks, depending on when their surgical procedure takes place. A small 
proportion of patients in Group 2 may have surgery on the same day of the initial consultation if this 
service is available. If patients are too anxious regarding the surgery taking place on the same day, they 
will not be invited to enter the study. The clinician who has direct care for the patient will assess the 
situation to make this decision, based on their clinical judgement.   
Patients will be deemed eligible to enter the study by the Chief Investigator (member of the DCT), once a 
histological diagnosis of NMSC is confirmed for patients who have consented to participate in the study. 
Participants will be provided with baseline questionnaires as detailed in section 7.4 following 
confirmation of study eligibility.  
7.4. Subsequent Visits 
Following the participant’s informed consent to participate in the study and confirmation of their 
eligibility (i.e. histological diagnosis of NMSC confirmed*), patients will be asked to complete a SCQOLIT 
and EQ-5D questionnaire according to the study schedule (Appendix A) at visit numbers: 
1) Baseline visit   
a) by post if patient is given their diagnosis by post (Group 1 – considered low risk skin cancer group 
as determined from Oxford Skin Cancer MDT guidelines) 
b) or face-to-face when the diagnosis is given in clinic (Group 2 – considered moderate – high risk 
skin cancer group as determined from Oxford Skin Cancer MDT guidelines) 
2) At 3 months follow up 
a) postal, for those patients discharged to community care, deemed ‘low risk’ (Group 1) 
b) or face-to-face if the patient is returning to the dermatology clinic for routine follow-up (Group 2 
– high risk skin cancer) 
3) At 6 – 9 months in the Dermatology clinic if the patient is deemed high risk i.e. squamous cell 
carcinoma with high risk clinicopathological features (denoted by the National BAD Multidisciplinary 
Guidelines for management of SCC) or rare NMSC (Group 2 only – See Appendix B). 
 
* Participants will be entered into the study and should have completed the baseline questionnaire 
within three weeks of the date that they were informed of their diagnosis of NMSC (not date of 
pathological diagnosis). 
 
There will be no additional visits to the clinic required for any aspect of the questionnaire study. The 
timeline for administering questionnaires in the clinic has been set according to the standard care 
pathway for these patients. This reflects routine clinical practice and the feasibility study is designed to 
run as close as possible to the standard pathway of care.  

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Participants will also receive a reminder telephone call from the Chief Investigator about each 
questionnaire once they receive them in the post to maximize response rates. This will occur 10-14 days 
after the questionnaires have been posted.  
 
Structured interviews (Group 3) will be undertaken after three to six months from date of entry into the 
study, for individuals who volunteer to be contacted by the Qualitative Researcher. Twenty individuals 
who have participated in the study from both Groups 1 and 2 will be invited to attend. Patients who 
volunteer their contact details will be informed that only 20 patients will be chosen at random for an 
interview. This is also written on the consent to provide details form. Patients will be contacted at 
random until 10 patients from Groups 1 and 2 have completed an interview. The interview will be 
undertaken at a time convenient to the patient in the Dermatology Outpatient Department.  
 
Group 4:  A clinician focus group will be undertaken to establish staff preferences and views regarding 
the study methodology and the SCQOLIT tool. This will be led by the Qualitative Researcher and 
supported by the Chief Investigator and will take place as part of the regular monthly Dermatology 
Departmental Clinical Governance meetings, which are undertaken to discuss service evaluation issues. It 
will involve 10 – 15 clinicians including Dermatology doctors, Dermatology nursing staff, skin cancer 
nurse specialists and health care assistants who have been involved in the questionnaire study. This will 
take place after the questionnaire and patient participant interviews have been analysed.  
7.5. Discontinuation/Withdrawal of Participants from Study 
Each participant has the right to withdraw from the study at any time.  In addition, the Investigator may 
discontinue a participant from the study at any time if the Investigator considers it necessary for any 
reason including: 
• 
New diagnosis of other serious medical or mental health condition that significantly impacts on 
quality of life.  
• 
Withdrawal of Consent 
Withdrawal from the study will not result in exclusion of the data for that participant from analysis, as 
these data will provide information regarding feasibility of use of the SCQOLIT in dermatology clinics. The 
reason for withdrawal will be recorded on the CRF. Withdrawn participants will not be replaced. If a 
withdrawing patient requests data to be excluded and/or destroyed this request will be adhered to. This 
has also been documented in the PIS.  
7.6. Definition of End of Study 
The end of study is the date of the last visit / telephone follow-up / interview of the last participant. 
8. STUDY DATA COLLECTION 
The data collected in this study are two quality of life questionnaires – the SCQOLIT tool (Appendix C) 
and the EQ-5D (Appendix D), which will printed on double-sided paper. These will be administered 
according to the schedule detailed in Appendix A. All patients will be designated a Questionnaire - 
Unique reference number (Q-URN) by the CI and this will be used on all questionnaires (rather than 
names or initials).  

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For Group 1 – Study questionnaires will be sent in a separate sealed envelope with the diagnosis letter to 
patients who have consented to the study. These will be completed at home and returned by post in a 
pre-paid envelope. A covering letter will be sent to patients explaining what they need to do [see 
example Covering letter]. The Chief Investigator will review all responses and if they are concerned that 
the patient has significant impairment of their QOL, then as part of the standard duty of care to these 
patients, the Chief Investigator will contact the patient to assess this further and arrange follow-up in the 
clinic or with the Skin Cancer Nurse Specialist as deemed clinically required.  
For Group 2 – Study questionnaires will be completed in the clinic. The questionnaires will be completed 
by the patient on their own and then reviewed by clinicians who are involved in the direct care of the 
patient and the scores will be calculated in the clinic. This has been agreed by Dermatology clinical staff 
at the Clinical Governance meeting (15th July 2014). Any specific high-scoring items identified will be 
discussed with the patient at the time. Any specific issues identified from the questionnaires will allow 
for open dialogue with the clinician. If there is sufficient concern that the patient has significant QOL 
impairment (score greater than 20/30 or any specific item scoring highly e.g. concerns about dying) then 
the patient will be referred to the Skin Cancer Nurse Specialist, as would be carried out as part of the 
standard care pathway for patients who are deemed to be significantly anxious or concerned about their 
diagnosis. This process is important as clinical staff will then be able to feedback at the focus group in the 
Dermatology Departmental Clinical Governance Meeting, regarding unmet needs and unidentified 
patient concerns. Any action taken by the clinicians will be reported to the CI and recorded on the CRF. 
Group 3: Interviews – Twenty patients from Groups 1 and 2 will be interviewed by the Co-investigator 
(Qualitative Researcher). This will take place after three to six months from date of entry into the study, 
for individuals who volunteer to be contacted by the Qualitative Researcher. The interview will be 
undertaken at a time convenient to the patient when they attend Dermatology Outpatients for a follow-
up appointment. All interviews will be recorded using Olympus DSS digital recorder and transcribed 
verbatim by the researcher. Data will be anonymous and identified by an Interview unique reference 
number (URN). The interview URN (I-URN) will be different to the Questionnaire study URN (Q-URN) so 
that the data cannot be linked. Participants will not be identified in any report. Only their gender and 
from which group they have been recruited from (i.e. Group 1 or 2 from the Questionnaire study) will be 
recorded. Patient consent forms, interview recordings and transcripts will be stored securely in locked 
cabinets/drawers at the University of Oxford. Electronic details will be encrypted and stored on 
password-protected University of Oxford computers. The Chief Investigator will have access to these 
data and there will be a filenote in the Research Study Master File stating where the data is being stored. 
Group 4: Focus Group (Clinicians) – Approximately 10 – 15 Dermatology clinical staff will be invited to 
attend focus group work to establish staff preferences, views and experiences of collecting PROMs data 
in a clinical setting. Their gender and role (Doctor or other) will be recorded. All focus group work will be 
recorded using Olympus DSS digital recorder and transcribed verbatim by the researcher. Data will be 
anonymous and unidentifiable and when published will not be able to be traced back to any individual. 
Data will be stored on password-protected computers in the University of Oxford.  
9. STATISTICS AND ANALYSIS 
9.1. Description of Statistical Methods 

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As this is a feasibility study, both quantitative and qualitative data will be analysed. There will be no 
specific interim analyses of data but for Group 2, patients who complete the questionnaires in clinic will 
also have the chance to discuss their scores with their clinician (as described above). Clinicians will have 
the opportunity to feedback specific issues for individuals to the Chief Investigator and this will be 
recorded on the CRF. They will also have the opportunity to discuss general issues at the Staff focus 
group in the Dermatology Departmental Clinical Governance meeting.  
Statistical analyses of PROM scores will be undertaken using Excel and SSPS software with statistical 
support from the Health Services Research Group, University of Oxford. Data reviewed will be in an 
anonymised form.   
All interviews will be recorded using Olympus DSS digital recorder and transcribed verbatim by the 
researcher. A framework analysis, developed from the interview schedule and from themes that 
emerged during fieldwork, will be conducted using NVivo V.10 qualitative analysis software. All coding 
will be performed by the Qualitative Researcher.  
9.2. The Number of Participants 
Overall, a minimum of 300 participants will be required to complete the feasibility study. This is based on 
previous studies having used much smaller numbers to validate the SCQOLIT tool (8). This is a realistic 
sample size which can be recruited from the Dermatology Department; patient recruitment figures are 
derived from median numbers (+/- range) of patients seen in the Oxford Dermatology Department in 
2013 with basal cell carcinoma (mean 160, range 140 – 172 / month) and squamous cell carcinoma 
(median 203, range 157 – 220 / month) obtained from a local departmental audit and the Skin Cancer 
Multidisciplinary Team Meeting IT data, respectively.  
For the qualitative aspects of the study (Group 3) there will be a total of 20 volunteers interviewed (10 
from each of Groups 1 and 2). 
For Group 4 there will be 10-15 clinicians invited to the focus group.  
9.3. Analysis of Outcome Measures/Endpoints 
All data will be included in the analyses as this is a feasibility study.  
The study is designed to explore the willingness of patients and clinicians to use the SCQOLIT 
questionnaire in a clinical setting, the ease of use of the SCQOLIT questionnaire and its usefulness in 
clinical practice. As mixed methods are being used, both quantitative and qualitative analyses will be 
undertaken.  
Acceptability of use of the SCQOLIT as a tool for PROM assessment in the Dermatology Tumour clinic will 
be assessed using mixed methods: 
1) Quantitative analysis of 
a) Patient participation rates 
b) Questionnaire response rates 
c) Missing values 
2) Qualitative analysis of patient and staff preferences, views and experiences 

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Psychometric properties of the SCQOLIT as a tool for patients with NMSC will be assessed by quantitative 
analysis of:  
a) 
Construct validity 
b) 
Responsiveness  
c) 
Clinically Important Difference 
d) 
Floor and ceiling effects 
e) 
Intra- and Inter-participant change scores 
This will be carried out by the Chief Investigator supported by the Health Services Research Group.  
The Qualitative Researcher will undertake qualitative analyses. A framework analysis, developed from 
the interview schedule and from the themes, which emerged during fieldwork, will be conducted using 
NVivo V.10 qualitative analysis software. 
10. DATA MANAGEMENT 
10.1. 
Access to Data 
Direct access will be granted to authorised representatives from the Sponsor or host institution for 
monitoring and/or audit of the study to ensure compliance with regulations. 
10.2. 
Data Recording and Record Keeping 
All data will be stored in the Research Study Master File by the Chief Investigator in a locked cabinet in 
the Dermatology Department Clinical Offices (1st Floor), Churchill Hospital. Patients will be assigned a Q-
URN code by the Chief Investigator and data will be anonymised. The Chief Investigator will be the only 
member of the research team who will be able to link the patient identifiable data with the Patient URN 
and this information will be stored in a password-protected Excel spreadsheet which is on a password-
protected NHS Computer based in the Dermatology Department Offices. Data from questionnaires will 
be entered onto a different Password-protected Excel spreadsheet for quantitative analyses. All data 
analysed in collaboration with the Health Services Research Unit, University of Oxford will be 
anonymised.  
Audio data will be stored using an I-URN (different to the Q-URN) and will be stored by the Qualitative 
Researcher on a password-protected University of Oxford computer in the Qualitative Researcher’s 
office in the Health Services Research Unit, Nuffield Department of Population Health, University of 
Oxford, Old Road Campus. In addition, only patient gender and the group from which they have been 
recruited from (i.e. Group 1 or 2 from the Questionnaire study) will be recorded. The location of these 
data will be referenced using a Filenote in the Research Study Master File held by the CI. The Qualitative 
researcher does not require access to patient medical records or clinical information except that which is 
anonymised research data for analysis. Only the CI will be able to link data to individuals.  
All research data (questionnaires, audio tapes, interview transcripts and consent forms) will be stored for 
5 years.  

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11. QUALITY ASSURANCE PROCEDURES 
The study may be monitored, or audited in accordance with the current approved protocol, ICH GCP, 
relevant regulations and standard operating procedures. 
12. ETHICAL AND REGULATORY CONSIDERATIONS 
12.1. 
Declaration of Helsinki 
The Investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki.  
12.2. 
ICH Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in full conformity with relevant regulations and 
with the ICH Guidelines for Good Clinical Practice (CPMP/ICH/135/95) July 1996. 
12.3. 
Approvals 
The protocol, informed consent form, participant information sheet and any proposed advertising 
material will be submitted to an appropriate Research Ethics Committee (REC), and host institution(s) for 
written approval. 
The Investigator will submit and, where necessary, obtain approval from the above parties for all 
substantial amendments to the original approved documents. 
12.4. 
Reporting 
The CI shall submit an Annual Progress report to the host organisation and Sponsor.  In addition, an End 
of Study notification and final report will be submitted to the same parties and the funding body if 
required. Participants who request information regarding the outcome of the study will be provided with 
a letter using the template [Outcome Letter]. 
12.5. 
Participant Confidentiality 
The study staff will ensure that the participants’ anonymity is maintained.  The participants will be given 
a URN by the CI and data will only be identified by their URN number on the CRF and on any electronic 
database.  All documents will be stored securely and only accessible by study staff and authorised 
personnel. The study will comply with the Data Protection Act, which requires data to be anonymised as 
soon as it is practical to do so. Participants will be de-identified and all documents assigned an 
anonymised code. Data will be stored on password-protected computers and hard copies of consent 
forms in secure, locked cabinets in Oxford University Hospitals NHS Trust. 
Recruitment to Group 3 will be offered to all patients who voluntarily provide their contact details for a 
potential interview. Their contact details will be collected by the Chief Investigator (part of the direct 
care team). Once the patient is entered into the Questionnaire study (i.e. has a confirmed diagnosis of 
NMSC), the CI will pass the patient details onto the Qualitative Researcher (Co-Investigator) who will 
contact selected participants at a later date. This information will be stored securely in a locked cabinet 

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in a locked office in the University of Oxford. This information will be destroyed as soon as the study is 
complete. 
 
Recruitment to Group 4 will be anonymised. The only personal details recorded will be role i.e. Doctor / 
Other (this includes nurses, health care assistants an cancer nurse specialists) and gender of the 
individual. No data will be linked back to individuals and they will not be assigned a URN. They will not be 
identifiable in any publication.  
13. FINANCE AND INSURANCE 
13.1. 
Funding 
Oxfordshire Health Services Research Committee grant awarded.  
13.2. 
Insurance 
NHS bodies are legally liable for the negligent acts and omissions of their employees. If a participant is 
harmed while taking part in a clinical research study as a result of negligence on the part of a member of 
the study team this liability cover would apply. 
Non-negligent harm is not covered by the NHS indemnity scheme. The Oxford University NHS Trust, 
therefore, cannot agree in advance to pay compensation in these circumstances. 
In exceptional circumstances an ex-gratia payment may be offered. 
14. PUBLICATION POLICY 
The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and 
any other publications arising from the study.  Authors will acknowledge that the study was funded by 
[pending]. Authorship will be determined in accordance with the ICMJE guidelines and other contributors 
will be acknowledged. 
Study results will not be routinely disseminated to study participants unless specifically requested. In 
these circumstances, participants will be provided with any publications that arise from this work.

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15. REFERENCES. 
1. Lord Darzi. NHS Next Stage Review Interim Report. October 2007. 
http://www.nhshistory.net/darzi-interim.pdf 
2. Improving Outcomes: A Strategy for Cancer – Third Annual Report. Dec 2013. 
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/264511/IOSC_
3rd_Annual_Report_-_Proof_version_-_9_December_2013_v2.pdf 
3. Andrew Wineberg. Provisional Monthly Patient Reported Outcome Measures (PROMs) in 
England. April 2014.  http://www.hscic.gov.uk/catalogue/PUB13751/prov-mon-proms-eng-
apr13-nov13-dat-qual-note.pdf 
4. Schofield , J , Grindlay , D & Williams , H 2009 , Skin conditions in the UK : a health care needs 
assessment . Centre of Evidence Based Dermatology, University of Nottingham. 
5. Gibbons E, Casañas i Comabella C, Fitzpatrick R. A structured review of patient-reported outcome 
measures for patients with skin cancer, 2013. Br J Dermatol. 2013 Jun;168(6):1176-86. 
6. Burdon-Jones D, Thomas P, Baker R. Quality of life issues in non-metastatic skin cancer. Br J 
Dermatol 2010; 162:147-51 
7. Rhee JS, Matthews BA, Neuberg M, Burzynski M, Nattinger AB. Creation of a quality of life 
instrument for non-melanoma skin cancer patients. Laryngoscope 2005; 115: 1178-85. 
8. Burdon-Jones D, Gibbons K. The Skin Cancer Quality of Life Impact Tool (SCQOLIT): a validated 
health-related quality of life questionnaire for non-metastatic skin cancers. J Eur Acad Dermatol 
Venereol. 2013 Sep; 27(9):1109-13. 
9. Motley RJ, Preston PW, Lawrence CM. Multi-professional guidelines for the management of the 
patient with primary cutaneous squamous cell carcinoma. London (UK): British Association of 
Dermatology (BAD); 2009 Dec 11; 34. 
 
 
 
 
 
 
 
 
 
 
 
 

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16. APPENDIX A:  STUDY FLOW CHART FOR ALL PARTICIPANTS. 
 
*Mode of giving diagnosis is standard care – pre-determined by Dermatology Skin Cancer MDT guidelines  
17. APPENDIX B:  SCHEDULE OF STUDY PROCEDURES FOR GROUP 2 – CLINIC-BASED. 
 
Procedures 
Visits  
Screening  
(Point of 
referral – first 
clinic visit)* 
Baseline (within 
three weeks of 
being given a 
diagnosis of NMSC 
– verbal or postal) 
3 
months 
follow 
up 
6 - 9 months 
follow up  
Informed consent 
Y (after being 
given PIS) 
Y 
 
 
Demographics 
Y 
 
 
 
Medical history 
Y 
Y 
 
 
Eligibility assessment 
(histological diagnosis of 
NMSC) 
Y 
 
 
 
SCQOLIT questionnaire 
and EQ-5D questionnaire 
 
Y 
Y 
Y (high risk 
SCC patients 
only) 
Structured interviews 
 
 
 
Y 
 
* This visit is applicable to all participants in the study including Group 1 (postal group) 

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18. APPENDIX C:  SCQOLIT TOOL Questionnaire. 
 
 

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19. Appendix D: EQ-5D Questionnaire. 
 

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20. Appendix E: AMENDMENT HISTORY 
 
Amendment 
No. 
Protocol 
Version 
No. 
Date 
issued 
Author(s) of changes 
Details of Changes made