A Qualitative Study of Patients' Attitudes to the Risks and Potential Benefits of Potential Toxicities of Radical Re-irradiation for Lung Cancer
Conditions: Lung Cancer, Recurrence
Sponsor: NHS Greater Glasgow and Clyde

 
 
 
A qualitative study of patients’ attitudes to the risks and 
potential benefits of potential toxicities of radical re-
irradiation for lung cancer  
 
 
 
Short title: Lung cancer patients’ attitudes to a second course of 
radiotherapy  
 
 
 
 
 
This study will be performed according to the UK Policy Framework for Health and 
Social Care Research (2017) and WORLD MEDICAL ASSOCIATION 
DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving 
Human Subjects 1964 (as amended). 
 
 
 
 
 
 
 
 
Sponsor: 
 
 
 
 
NHS Greater Glasgow & Clyde 
Funders: 
 
 
 
 
The Beatson Cancer Charity (TBC) 
Conflict of interest statement: 
None of the protocol authors have declared a 
potential conflict of interest 
 
 
 
 
 
 
 
 
 
Protocol version and date: 
Version 1.6, 18/02/2021 
IRAS project number: 
 289918 
NHS GG&C R&I reference number: 
GN20ON632 
REC number: 
21/SS/0015 

 
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Key study contacts 
 
Principal Investigator/PhD student 
Dr Robert Rulach 
 
 
 
 
 
Level 4, Registrar Room, 
The Beatson West of Scotland Cancer Centre, 
1053 Great Western Road, 
Glasgow, G12 0YN 
E-mail: Robert.Rulach@ggc.scot.nhs.uk 
 
Supervisors 
 
 
 
Dr Stephen Harrow 
The Beatson West of Scotland Cancer Centre, 
1053 Great Western Road, 
Glasgow, G12 0YN 
 
Prof Anthony Chalmers 
University of Glasgow  
Wolfson Wohl Cancer Research Centre,  
Institute of Cancer Sciences,  
Garscube Estate,  
Glasgow, G61 1QH 
 
Qualitative Research Lead 
 
Dr Katie Robb 
 
 
 
 
 
The University of Glasgow 
Institute of Health and Wellbeing,  
Gartnavel Royal Hospital, Admin Building, 1st Floor, 
1055 Great Western Road, Glasgow, G12 0XH 
 
Sponsor 
 
 
 
NHS GGC R&I Sponsor 
Emma-Jane Gault 
 
 
 
 
 
Room 327, 
 
 
 
 
 
Wolfson Medical School Building, 
 
 
 
 
 
University Avenue, 
 
 
 
 
 
Glasgow, G12 8QQ 
 
 
 

 
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CONTENTS 
 
Synopsis 
4 
1. Introduction 
5 
1.1. Lung cancer and recurrence 
 
1.2. Current treatments for recurrent disease 
 
1.3. Current evidence for radical re-irradiation 
 
1.4. Need for a prospective trial of radical re-irradiation  
 
1.5. Patient acceptance of re-irradiation 
 
1.6. Patient attitude to risk of toxicity 
 
1.7. Relationship of symptoms from initial radiotherapy and willingness for re-
treatment 
 
1.8. Choice of Quality of Life scoring system and need for a baseline 
comparator 
 
1.9. Rationale and summary 
 
2. Aims and Objectives 
9 
2.1. Aims 
 
2.2. Primary objectives 
 
2.3. Secondary objectives 
 
3. Methodology 
10 
3.1. Study design 
 
3.2. Inclusion and exclusion criteria 
 
3.3. Recruitment and sampling 
 
3.4. Consent 
 
3.5. Semi-structured interview 
 
3.6. End of study 
 
3.7. Potential risks and benefits 
 
3.8. Mitigation for SARS-CoV-2 
 
3.9. Data storage and retention 
 
4. Statistical considerations and method of analysis 
14 
4.1. Sample size 
 
4.2. Method of analysis 
 
5. Ethics 
15 
6. Finance and indemnity 
16 
7. Publications 
17 
8. References 
18 
Appendix A – Attitudes to Re-irradiation literature search  
20 
Appendix B – Consent form, Patient Information sheet, Interview structure 
21 
 
 
 

 
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SYNOPSIS 
 
 
Study Title: 
 
A qualitative study of patients’ attitudes to the risks and potential 
benefits of radical re-irradiation for lung cancer 
 
 
Study Design: 
 
 
Single centre, qualitative interviews 
 
Study Objectives: 
 
Primary Objective 
 
(1) Explore patients’ feelings and concerns about having a second 
course of radiotherapy for recurrent lung cancer 
 
Secondary Objectives 
 
(1) Identify factors that patients consider when deciding on 
potential treatments in the setting of locally recurrent lung 
cancer (including effect of COVID-19 on treatment choice) 
(2) Investigate how patients’ acceptance of side effects changes 
with the different projected outcomes of re-irradiation 
(3) Explore the relationship between the toxicities patients 
experienced during radiotherapy and their attitudes to a 
second course of radiotherapy 
(4) Investigate patients’ awareness of surveillance imaging after 
radical treatment and willingness for scans 
 
 
Study Population: 
 
Patients treated in the West of Scotland Cancer Centre who have 
completed a course of radical radiotherapy to their thorax for lung  
cancer 
 
 
Procedure: 
 
• 
Consent patient during radiotherapy (at radiotherapy on-
treatment review clinic) 
• 
Confirm consent and arrange interview at 4 weeks after 
completion of radiotherapy 
• 
Semi-structured interview at 5 weeks after completion of 
radiotherapy (by telephone or video consultation) 
 
 
Outcome: 
 
Identification of patients’ concerns regarding re-irradiation to direct 
future clinical trial design 
 
 
 
 
 

 
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1. INTRODUCTION 
 
1.1 
Lung cancer and recurrence 
 
Lung cancer is the most lethal malignancy in the UK, with over 45,000 people diagnosed 
each year, and over 39,000 deaths1. Of those suitable for radical treatment, it is estimated 
that approximately 45% of lung cancer patients (approximately 5,000 patients in the UK) will 
have radical radiotherapy to their chest as part of initial treatment2. However, there is a 
substantial risk of either: isolated recurrent thoracic disease (which occurs in 20-30% of 
patients with non-small cell lung cancer (NSCLC) treated with radiotherapy or 
chemoradiotherapy3,4) or; development of a second primary lung cancer (the risk of which is 
14% over 10 years after initial treatment5). There are an estimated 800 patients per year in 
the UK who may be suitable for further radical treatment yet there are no clear treatment 
guidelines in this situation.  
 
1.2. 
Current treatments for recurrent disease 
 
For patients with recurrent disease or a metachronous lung primary, treatment options 
comprise systemic treatment, surgery, or thoracic re-irradiation. Each has risks and potential 
benefits.  
 
Systemic therapies may be very effective for patients with EGFR mutated, ALK rearranged or 
PDL1 expressing tumours with disease control lasting for many months or years6,7,8. 
Unfortunately, this applies to a minority of patients: EGFR mutations and ALK re-arrangements 
are present in only 10% of NSCLC cases, and high PDL1 levels are seen in 24 to 28%. In 
patients without these molecular biomarkers, cytotoxic chemotherapy offers a median 
progression free survival of only 4 months9. With all systemic treatments, the patient is 
continually ‘on treatment’ and must attend hospital clinics regularly for assessment and blood 
tests, while experience multiple potential side effects that may be severe enough to cause 
hospitalisation, the risk of which is up to 68%9 for patients receiving cytotoxic chemotherapy. 
In addition, systemic treatments (with the exception of immunotherapy) rarely offer long-term 
disease control.  
 
Life extending options for localised disease recurrence are surgery or radical re-irradiation. 
For surgery, patients need to be fit enough to tolerate a major operation, which is often not the 
case due to the prevalence of cardiac and respiratory co-morbidities in this group. Radical re-
irradiation can offer long-term disease control in selected patients and avoids the risks of 
surgery. Radiotherapy is generally completed within a few weeks (typically 2-6 weeks), and 
patients are monitored without treatment until their clinical condition changes, which could be 
many months or years. This compares well to systemic therapies, where patients would be on 
2-4 weekly cycles of treatment until disease progression, with the continual risks of toxicity.  
 
However, re-irradiation may cause severe toxicities in some patients. This is likely to be due 
to the cumulative dose received by the normal tissues surrounding the tumour. There is limited 
evidence to predict how normal tissues recover after an initial course of radiation. This means 
that it is unclear what the cumulative dose limits are for the organs at risk (OAR) in the thorax. 
Furthermore, some recurrent cancers may be resistant to radiotherapy, leading to concerns 

 
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about futility of treatment. Therefore, it is important to develop high quality prospective trials 
to determine the safety and efficacy of radical re-irradiation. 
 
1.3. 
Current evidence for radical re-irradiation 
 
Thoracic re-irradiation has been performed since 1963 with variable results and toxicities10. 
The benefits are good symptom control when given at palliative doses and long-term 
disease control in a minority of patients who are radically treated. There is currently a lack of 
high level evidence to inform clinicians of the safety and efficacy of radical re-irradiation, with 
only one prospective phase 1 study evaluating thoracic re-irradiation and several 
retrospective reviews11.  
 
The phase I study (Wu et al. 2003) evaluated radical dose, conventionally fractionated re-
irradiation to recurrent lung cancers in 23 patients, who received a median dose of 66 Gray 
(Gy) at first treatment, and 51 Gy at re-irradiation. Median overall survival (OS) from re-
irradiation was 14 months (range 2-37), with no acute grade 3 or greater toxicities recorded 
(RTOG grading). There was a 22% rate of grade 1-2 pneumonitis and 9% rate of grade 1-2 
oesophagitis. There have been several retrospective reviews of re-irradiation using radical 
doses and conventional fractionation12,13,14,15,16. For radical dose re-irradiation, median OS in 
these reviews ranged from 7.1 to 13.5 months with 1 year local control rates of 57% to 66%. 
The radiotherapy techniques used in these studies are often outdated (e.g. 3D conformal 
radiotherapy) and have methodological flaws including inaccurate toxicity reporting since 
they are database reviews, rather than prospective trials. 
 
1.4. 
Need for a prospective trial of radical re-irradiation 
 
Local data from the Beatson West of Scotland Cancer Centre demonstrates that only 6.7% of 
the expected number of patients who may be eligible for re-irradiation receive this treatment. 
Reasons for the low uptake of this treatment include: limited prospective trial data 
demonstrating efficacy, concerns about safety, no clear guidance on surveillance post-radical 
radiotherapy leading variable detection of recurrence and patient refusal. A Canadian working 
group documented clinician’s opinions on offering re-irradiation, with 35% declining to re-treat 
a standardized case17. As there clearly are different opinions on optimal treatment for patients 
with recurrent disease, a contemporary prospective clinical trial is warranted. The outcomes 
of this study would be robust data on safety, local control and overall survival. This will help 
develop treatment options for patients with recurrent disease. A recent survey of UK clinical 
oncologists demonstrates widespread enthusiasm for contemporary re-irradiation studies, 
with 76% of responders interested in further research on this topic18.  
 
 
1.5. 
Patient attitudes to re-irradiation 
 
The key aim of this study is to elucidate patients’ concerns about re-irradiation. This 
information is needed to firstly assess whether patients would accept re-irradiation as a 
treatment. Secondly, any barriers to participation identified in this qualitative study can be 
addressed in the clinical trial design. A literature search yielded no published data regarding 
patient acceptance or patient experience of re-irradiation for any tumour groups (see 
Appendix A). There could be many reasons why patients do not want to have re-irradiation 

 
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such as reluctance to undergo uncomfortable repeat investigations, issues regarding 
transport to the radiotherapy centre, side effects from the original treatment or anxiety about 
experimental treatment. Awareness of patients’ concerns about re-irradiation is crucial to 
develop a feasible clinical trial.  
 
1.6. 
Patients’ consideration of alternative treatments in the locally recurrent setting 
 
As previously mentioned, no guidelines exist for the treatment of locally recurrent lung 
cancer. The choices for patients include systemic treatment, radical radiotherapy or a watch 
and wait strategy in asymptomatic patients. How patients choose between these treatment 
options is important to explore because any randomization in a prospective trial will need 
both equipoise from the clinician, but also patient agreement that either treatment arm is 
appropriate. There are no published data on this topic. This discussion is particularly 
pertinent during the COVID-19 pandemic as patients and clinicians attempt to reduce the 
amount of hospital visits and treatments that could deplete the immune system. This 
interview study will identify what treatments patients would agree to, thereby improving the 
future trial design. 
 
1.7. 
Relationship of symptoms from initial radiotherapy and willingness for re-treatment 
 
Joseph et al., when reporting a re-irradiation workshop, stated that patients who tolerated 
initial radiotherapy poorly were  unsuitable for re-irradiation17. This refers to clinicians’ 
concerns of causing severe toxicity with re-irradiation and may be a barrier to successful trial 
recruitment. Historically, re-irradiation has a significant risk of toxicity. The rates of severe 
toxicity may be lower using the newly published cumulative dose constraints, although these 
need validation. There are no prospective published data regarding whether patients who 
have toxicities are less likely to want further treatment. There is a need to identify if there is a 
relationship between the severity of patients’ symptoms during initial treatment and their 
willingness for re-irradiation. This study will explore whether, despite toxicities from first the 
first radiotherapy course, patients still would consider aggressive re-treatment, and if so, 
what changes would they want to make their second course of radiotherapy more tolerable. 
 
 
1.8. 
Patients’ attitude to risk of toxicity 
 
The safety of the prospective re-irradiation clinical trial depends in part on the use of 
cumulative dose constraints to the normal tissue OARs. The evidence for re-irradiation dose 
constraints is limited. In general, the higher the cumulative dose to an OAR, the greater the 
risk of toxicity. There is no published evidence describing patient’s attitude to risk, and what 
toxicities they would accept for a given outcome. 
 
In addition, new radiotherapy technology has become available to distribute the dose of 
radiotherapy across different OARs. The first iteration of this approach is intensity modulated 
radiotherapy (IMRT) which is now the standard of care for radiotherapy in many tumour 
sites. The benefit of this approach is to reduce the areas receiving a high dose of 
radiotherapy, but increase the area receiving a low dose bath. By reducing the OARs 
receiving the highest dose, the side effects patients develop are reduced. 
 

 
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One development of IMRT is multi-criteria optimisation (MCO). This uses a planning 
algorithm which generates multiple plans simultaneously. This allows the clinician to keep 
the tumour dose the same, but shift the dose from different OARs, to achieve the best plan. 
Recent work has demonstrated that using MCO in re-irradiation planning can reduce dose to 
the oesophagus significantly, at the cost of increasing the dose to the lungs19. The 
significance for the patient is that the clinician is reducing the risk of oesophagitis and 
swallowing difficulties, but increasing the risk of pneumonitis and breathlessness. There is 
no published evidence describing what side effects lung cancer patients would accept and, if 
they had to have a side-effect, which would they prefer. Further research into this will guide 
clinicians to make treatment planning decisions with patient input. 
 
1.9. 
Attitudes to surveillance after radical radiotherapy 
 
Any future prospective trial in recurrent lung cancer requires timely detection of local relapse.  
Recent guidelines have suggested surveillance CT scans every 6 months to detect recurrent 
disease, although the strength of evidence supporting these recommendations are weak. 
The majority of studies focus on the overall benefits that surveillance has on outcome and 
very few report on patient’s quality of life. This interview study will explore patients’ attitudes 
to surveillance scanning, and discuss the benefits and risks of either approach. Further 
information on this is important in the context of a re-irradiation trial as it is anticipated that 
surveillance CT scans will be a key method of identifying suitable trial patients. 
 
1.10. Rationale and Summary  
 
A prospective clinical trial to evaluate radical re-irradiation for lung cancer is urgently needed, 
as there are no contemporary robust trial data about this treatment. The results could have 
significant benefits for an under-served lung cancer population, by finding out which patients 
should receive re-irradiation, and how to deliver re-irradiation safely. However, to ensure that 
this interventional trial is designed appropriately and that it recruits well, it is necessary to 
interview patients who have already completed one course of radiotherapy. This group of 
patients have been chosen because they would be eligible for the re-irradiation clinical trial, 
and they have experienced radical lung radiotherapy and its side-effects. 
 
The purpose of this qualitative study is to discover what the potential barriers to accepting re-
irradiation are, explore patients’ attitudes to alternative treatments for local recurrence, what 
side effects are most concerning, and acceptance of surveillance CT scans. To be able to 
explore fully patients’ concerns and attitudes, semi-structured interviews will be conducted. 
The interviews will take place after patients have completed their first course of radiotherapy. 
The information learnt from these patients’ experience will shape a future re-irradiation 
prospective trial protocol to ensure that it is both acceptable to patients and clinically relevant.  
 

 
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2. AIMS AND OBJECTIVES 
 
2.1 Aims 
 
The aim of this study is to explore patients’ experience of radical radiotherapy for lung 
cancer and their attitudes to having a second treatment. 
 
2.2. Primary Objectives 
 
(1) Explore patients’ feelings and concerns about having a second course of 
radiotherapy 
 
2.3. Secondary Objectives 
 
 
(1) Identify factors that patients consider when deciding on potential treatments in 
the setting of locally recurrent lung cancer (including effect of COVID-19 on 
treatment choice) 
(2) Investigate how patients’ acceptance of side effects changes with the different 
projected outcomes of re-irradiation 
(3) Explore the relationship between the toxicities patients experienced during 
radiotherapy and their attitudes to a second course of radiotherapy 
(4) Investigate patients’ awareness of surveillance imaging after radical treatment 
and willingness for scans 
 

 
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3. METHODOLOGY 
 
3.1. 
Study design 
 
This is a qualitative interview study. The semi-structured qualitative interviews will take place 
after radiotherapy is completed and explore positive and negative aspects of that treatment, 
followed by discussion about concerns about re-irradiation, and risk of side-effects. Figure 1 
provides an overview of the study design. 
 
3.2. 
Inclusion and Exclusion Criteria  
 
Patients must meet all of the following inclusion criteria to be considered for this study: 
• 
Age 18 years old or above 
• 
Pathological or radiological diagnosis of non-small cell lung cancer 
• 
Undergoing radical radiotherapy to the thorax using the following fractionations (55 
Gray in 20 fractions, 54 Gray in 36 fractions or any Stereotactic Ablative Body 
Radiotherapy (SABR) fractionation that delivers a biological effective dose of greater 
than 100Gy10) as part of their primary lung cancer treatment at time of study 
enrolment 
• 
Patients receiving concurrent and/or adjuvant systemic therapies are permitted 
• 
Radiotherapy is delivered in the Beatson West of Scotland Cancer Centre 
• 
Signed, written informed consent  
• 
Willing and able to complete study processes  
 
Patients who meet any of the following exclusion criteria will not be enrolled on to the study: 
• 
Not fluent in English 
 
3.3. 
Recruitment and sampling 
 
In order to ensure adequate representation of patients receiving systemic treatment and 
different types of radiotherapy (as their experience of treatment will vary considerably), four 
patients will be recruited from each of the following radiotherapy sub-types: SABR, 
Continuous hyperfractionated accelerated radiotherapy CHART, concurrent 
chemoradiotherapy and radiotherapy alone.  
 
For patients undergoing SABR, they will be approached by a radiographer at their mould 
room appointment, where the aims of the study and the study procedures will be explained, 
and participant information sheet will be given to them. They will then have approximately 3 
weeks to consider this information. When they return to have their radiotherapy, the 
radiographer will enquire if they wish to be involved in this study. If so, they will be seen by 
the researcher for consent on the same day. 
 
Patients receiving CHART, concurrent chemoradiotherapy, or radiotherapy alone, will be 
recruited through the on-treatment review clinic. This clinic at the Beatson West of Scotland 
Cancer Centre is where patients having radical radiotherapy are monitored every week 
during their treatment. It is staffed by clinical nurse specialists and radiographers. They will 
pre-screen new patients attending their first/second on-treatment review clinic during the first 

 
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two weeks of radical radiotherapy. Patients who meet the inclusion criteria will be 
approached by the clinical nurse specialist/radiographer in the clinic. The aim of the study 
and the study rationale will be described and an information sheet will be given to the 
patients (see Appendix B).  
  
3.4. 
Consent 
 
When the patient returns to the Beatson for the on-treatment radiotherapy review in the 
following week (i.e. the second/third week of treatment), or in the first week of radiotherapy 
treatment for patients receiving SABR, the nurse specialist/radiographer will ask the patient if 
they would like to discuss the study with the researcher. If the patient agrees, the patient will 
meet the researcher and answer any questions. If the patient wishes to participate in the 
study, they will complete three consent forms with the researcher, one for the patient to 
keep, one for the site file and one for the medical notes. Consent will be re-confirmed at the 
pre-interview phone call and at the start of the interview. If the patient would like to conduct 
the interview using the NHS Anywhere virtual consultation platform, a web address will be 
given to the patient at this point. 
 
3.5.  
Semi-structured interview 
 
The patient and the researcher will arrange a mutually convenient time for the qualitative 
interview 4 weeks after completion of radiotherapy (+/- 5 days). On this pre-interview call, 
the patient will also re-confirm the consent to be involved in this study. If the patient wished 
to use the NHS Anywhere platform, then the web address will be also re-confirmed with 
them. Patients will also be invited to have a family member or friend nearby for the interview 
to offer support if needed. The interview will be performed after 5 weeks as it allows for most 
of the acute side effects of treatment to subside, but the patient would not have any idea of 
how effective the treatment has been, as this may bias their answers. The interview will be 
done either over the telephone or using the NHS Anywhere virtual consultation platform. The 
interview will be recorded. At the start of the interview, consent will also be re-confirmed. The 
structure of the interview is documented in Appendix B.  
 
As some of the topics of the interview could be distressing, if at any point during the 
interview the patient becomes upset, the interview will be paused and the patient given time 
to recover. The interview can proceed again only once the patient agrees to do so, otherwise 
the interview will be permanently stopped. As the interview will be conducted over the 
telephone, if the patient needs further support and consents to it, the researcher will contact 
the patient’s clinical team and request that they contact the patient to offer further care. In 
addition, the patient may have a member of family or a friend with them to assist them. The 
patient will also have a routine follow-up visit with their clinical team one week after the 
interview, where they may wish to discuss any issues which have arisen from the interview.  
 
During the interview, if the patient describes any symptoms or issues that require medical 
attention the researcher may inform the patients’ clinical team with the patients’ consent. The 
recording of the interview will be anonymised, transcribed and stored securely on the NHS IT 
systems. 
 
 

 
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Figure 1. Study schema 
 
 
 
 
At the following week on-treatment 
clinic review, the clinical nurse 
specialist/radiographer offers the 
patient further discussion with the 
researcher  
Patient contacted by telephone to 
confirm consent and arrange 
interview time and date at 4 weeks 
after the final fraction of 
radiotherapy (+/-5 days) 
For non-SABR patients: 
Clinical nurse 
specialist/radiographer 
approaches patient at first or 
second on-treatment review clinic 
of radiotherapy, discusses aim of 
trial and gives PIS 
Researcher consents patient and 
assigns trial number  
Transcription, anonymisation and 
thematic analysis of interview data  
Semi-structured interview 
conducted at 5 weeks after the final 
fraction of radiotherapy (+/-5 days) 
Publication of results  
During the first week of SABR 
radiotherapy, the radiographer 
offers the patient further 
discussion with the researcher  
For SABR patients: 
Radiographer approaches patient 
at their mould room appointment 
(during radiotherapy planning), 
discusses aim of trial and gives 
PIS 

 
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3.6. 
End of study 
 
The patient will have completed the study once the interview has ended. They will be given 
the option to be kept informed about the outcomes of the study and ongoing work. At any 
point, patients can withdraw from the study with no change to their medical treatment. Once 
the patient has left the study, they will be followed-up as per standard practice of their 
treating clinical oncologist. 
 
3.7. 
Potential risks and benefits  
 
The principal risk of this study is that any discussion of traumatic experiences such as being 
unwell or relapse after arduous treatment can cause significant psychological harm. The 
steps taken to mitigate this risk are to inform the patient from the outset of the topics that will 
be discussed in the interview in both the patient information sheet and in the consent 
process. If the patient becomes distressed in the interview, then the interview will be halted 
and further support offered (from the patient’s regular clinical team, and, if the patient has 
agreed, a member of their family or a friend). 
 
The patient will have no direct benefit from taking part in this study as this study does not 
involve any change in the medical care that the patient receives. However, the results from 
the study will help the design of a prospective trial of re-irradiation, and this will improve the 
safety of this treatment for future patients. Additionally, the results of these interviews may 
identify areas to improve the patient experience in patients having initial radiotherapy at the 
Beatson West of Scotland Cancer Centre. 
 
3.8.  
Mitigation for SARS-CoV-2 
 
The WHO declared a global pandemic in response to the novel severe acute respiratory 
syndrome coronavirus-2 (SARS-CoV-2) in early 2020. In order to limit patients’ exposure to 
potential infectious contacts, this study will perform most of the study procedures over either 
the telephone or using secure remote consultation software. The patient will meet the 
researcher in person only once, when consent is being taken, at the same time as they are 
attending the on-treatment radiotherapy review clinic, thus reducing the need for additional 
visits to hospital. 
 
3.9.  
Data storage and retention 
 
The interviews will be recorded on to the Winscribe system (this is the system used for 
recording clinic dictations in the Beatson). The recordings will be password protected. They 
will be transcribed either by the researcher, or NHS clerical staff. The original recordings will 
be stored securely on the NHS IT system until the end of the study, as source data in case 
of audit. Once the trial is complete, the source recordings will be destroyed. The source 
recording will be transcribed and anonymised. The anonymised transcripts will be 
transferred to the University of Glasgow IT systems for analysis using NVivo software. Once 
analysis is complete, this study will be written for publication. The anonymised transcribed 
source data will be uploaded on to the Enlighten data repository curated by the University of 
Glasgow, where it will be kept for at least 10 years and will be accessible to other 

 
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researchers on application as per the University of Glasgow data protection policy. 
Anonymised data from this study may be used in other studies if appropriate. 
 
 

 
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4. STATISTICAL CONSIDERATIONS AND METHOD OF ANALYSIS 
 
4.1 
Sample Size 
 
The estimated minimum target recruitment for this study is 16 patients, based on the 
likelihood that data saturation has been achieved20. If saturation has not been achieved, then 
the study will continue to recruit to a maximum of 30 patients. 
 
 
4.2 
Method of analysis  
 
The anonymised transcripts will be uploaded to NVivo software, provided by the University of 
Glasgow. The interviews will then undergo thematic analysis to identify key attitudes to re-
irradiation. 
 
There is a quantative element to this study, where patients are asked to rate the severity of 
side effects from radiotherapy (describing their side effects as either mild/moderate or 
severe) and if they would consider a second course of radiotherapy. These will be analysed 
using descriptive statistics and Chi-squared testing. 
 

 
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5. ETHICS  
 
Consent and ethics approval 
 
All patients who participate in this study must have signed the written consent form 
(Appendix B). This study is subject to ethics approval from the West of Scotland Research 
Ethics Committee.  
 
Confidentiality 
 
Patients participating in this study will be given a trial number, which will be used on the 
interview recordings and transcripts. The original recordings will be stored securely on the 
NHS IT systems. The recordings will be transcribed and anonymised. Any identifiable patient 
information in the transcripts will be redacted. The source recordings will be retained until the 
end of the study, as source data in case of audit. Once the study is complete, the source 
records will be destroyed.  All data will be stored on secure password protected NHS or 
University of Glasgow IT systems.  
 
 
 
 

 
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6. FINANCE AND INDEMNITY  
 
 
Indemnity 
 
No special insurance is in place regarding this study. 
 
Sponsor 
 
NHS Greater Glasgow and Clyde will act as the sponsor for this study. 
 
Funding 
 
This study is funded by a grant from the Beatson Cancer Charity and The University of 
Glasgow. 
 
 

 
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7. PUBLICATIONS  
 
The results of this study will be part of the principal investigator’s PhD thesis, but also written 
for publication, and disseminated at posters and presentations at relevant conferences. The 
study findings will also be sent to the patients (if they wish to receive updates). 
 
 

 
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8. REFERENCES 
 
1.  
Cancer Research UK. http://www.cancerresearchuk.org/health-professional/cancer-
statistics/statistics-by-cancer-type/lung-cancer/incidence#heading-Two. Accessed 
June 26, 2017. 
2.  
Tyldesley S, Boyd C, Schulze K, Walker H, Mackillop WJ. Estimating the need for 
radiotherapy for lung cancer: an evidence-based, epidemiologic approach. Int J 
Radiat Oncol. 2001;49(4):973-985. doi:10.1016/S0360-3016(00)01401-2. 
3.  
Mauguen A, Le Péchoux C, Saunders MI, et al. Hyperfractionated or Accelerated 
Radiotherapy in Lung Cancer: An Individual Patient Data Meta-Analysis. J Clin Oncol. 
2012;30(22):2788-2797. doi:10.1200/JCO.2012.41.6677. 
4.  
Curran WJ, Paulus R, Langer CJ, et al. Sequential vs Concurrent Chemoradiation for 
Stage III Non-Small Cell Lung Cancer: Randomized Phase III Trial RTOG 9410. JNCI 
J Natl Cancer Inst. 2011;103(19):1452-1460. doi:10.1093/jnci/djr325. 
5.  
Jeremic B, Shibamoto Y, Acimovic L, et al. Second Cancers Occurring in Patients 
With Early Stage Non–Small-Cell Lung Cancer Treated With Chest Radiation Therapy 
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Version 1.6, 18/02/2021 
21 
APPENDIX A 
 
Literature review 
 
We performed a literature search to identify if this information was available from published 
studies. 
 
Search engine used: Medline, Google scholar 
 
Search terms:  
 
Re-irradiation AND (patient experience OR attitudes OR acceptance) = 43 papers (2 useful) 
Sinfield et al. 2009 
Joseph et al. 2010 
 
Lung cancer AND radical radiotherapy AND patient experience = 360 papers (1 useful) 
Langendijk et al. 2001 
 
Lung cancer AND radical radiotherapy AND symptom control = 93 papers (1 useful) 
Fairchild et al. 2008 
 
 
 
 
Lung cancer AND (re-treatment OR re-irradiation OR "retreatment" OR "reirradiation") AND 
Patient experience = 36 papers (1 useful)  
Shalini et al. 2019 
 
Lung cancer AND (re-treatment OR re-irradiation OR "retreatment" OR "reirradiation") AND 
symptom control = 126 papers, 1 useful) 
Kruser et al. 2014 
 
 
Limits – English language 
 

 
Version 1.6, 18/02/2021 
22 
APPENDIX B 
 
Copy of patient information sheet 
Copy of consent form 
Copy of semi-structured interview sheet