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Understanding the experiences of cancer patients referred for a clinical trial during the COVID-19 pandemic

26 January 2023
Volume 32 · Issue 2


Background: The COVID-19 pandemic affected cancer patients regardless of the stage of their diagnosis or treatment. Aims: To understand the experiences of cancer patients who were referred for a clinical trial at that time. Method: Cancer patients who attended their initial research outpatient appointment to discuss the possibility of taking part in a clinical trial were asked to complete the Generalised Anxiety Disorder Assessment questionnaire, and take part in semi-structured interviews. Findings: Data indicated that, on average, patients had moderate levels of anxiety. Three major themes emerged from patients’ interviews, which gave an insight into what they experienced during this challenging period. Conclusion: This study gives an insight into the experiences of cancer patients who were referred for a clinical trial at the height of the COVID-19 pandemic. It illustrated the impact of social distancing and the effect of virus-related fear on cancer patients’ mental health.

Patient care was profoundly affected during the COVID-19 pandemic because of the need to minimise patient and staff exposure to the virus (Dietz et al, 2020). In health care, social distancing measures were imposed and the use of personal protective equipment in everyday procedures was made mandatory for NHS staff (Mantelakis et al, 2021).

In cancer services, one of the main consequences of the pandemic has been the overall reduction in the number of people having their cancer diagnosed at an early stage, due to the reduction in the availability of screening services (Lai et al, 2020). A long-term effect of this is that the pandemic is predicted to increase the number of people presenting with advanced cancer in the future (Nossiter et al, 2022).

Following the introduction of social distancing guidelines, cancer patients attending hospital appointments were told to do so without being accompanied by family members, many patient appointments were cancelled, and telephone or video consultations were used to reduce inpatient time (Drury et al, 2021). Additionally, the NHS adapted cancer treatment services, which meant that, in some cases, patients would have their cancer treatments delivered to their homes (Shankar et al, 2020). In some areas of the UK, drive-through services for the collection of medicines and blood tests were also set up (Shankar et al, 2020).

Research on how the pandemic has affected cancer patients’ experiences indicated that the treatment of1 in 3 cancer patients had been negatively impacted, and 2 in 3 cancer patients reported that their cancer care (defined as everything patients would expect as part of their care, such as support for their emotional wellbeing or mental health and physiotherapy, and reconstructive surgery) had been adversely affected (Cancer Research UK, 2020. The research also indicated that the pandemic had a detrimental impact on cancer patients’ psychological wellbeing, identifying that it had increased levels of anxiety and frustration due to concerns relating to catching COVID-19 and becoming seriously ill (Cancer Research UK, 2020).

Further research found cancer patients indicated that they were reluctant to use cancer healthcare services during this challenging time due to infection worries (Dhada et al, 2021 Cancer patients as a group have experienced fear of the virus, mostly because of the fact that they are a high-risk population, and so more prone to infection due to their often immunosuppressed condition (Bahçecioglu et al, 2022).

Accessing clinical trials during the pandemic

In some cases, cancer patients may enrol on to clinical trials to get access to an additional treatment option, once their standard treatments have stopped working (Hulbert-Williams et al, 2021). At the height of the pandemic, these opportunities were dramatically reduced nationally. At the beginning of the pandemic, the National Institute for Health and Care Research (NIHR) paused the set-up of any new clinical trials at NHS and social care sites that were not nationally prioritised COVID-19 studies (NIHR, 2020).

Research around the impact of COVID-19 on the experiences of cancer patients accessing clinical trials is an area that needs further investigation (Shiely et al, 2021). In some small-scale studies cancer patients reported that they would not participate or would need to have their concerns addressed before taking part in a clinical trial, even if it were the only treatment option available (Cancer Research UK, 2020).

The impact of COVID-19 on cancer trials to a large extent reflected the wider context of changes to cancer care in the UK (Fox et al, 2021). Patients’ study visits were reduced and adapted to include telephone and online video appointments with their doctor and/or research nurse (Lamont et al, 2021). However, little is known about the lived experiences of cancer patients taking part in clinical trials during that time, or what lessons can be learnt to develop future practice.

Background to study

In 2020, a doctoral study was commenced to examine the impact of a patient co-designed educational intervention within the clinical pathway for cancer patients who were referred for a clinical trial in Newcastle upon Tyne.

The study was developed from the practical experiences, research and new knowledge unearthed during a 2017 service evaluation project (Hood, 2020). In this service evaluation, the involvement of a patient and public involvement (PPI) group identified a lack of information and knowledge among cancer patients who were referred to clinical trials (Hood, 2020). The PPI group supported the development of an educational booklet that was able to improve patients’ knowledge and experience (Hood, 2020).

As part of this study, a patient co-designed website was developed and an approach to using the website and booklet at referral centres was devised.

One of the primary aims of this research was to investigate whether these educational interventions reduced anxiety levels in cancer patients who were referred for a clinical trial. Unfortunately, at the same time that permissions were granted by the Research Health Authority to start this study the COVID-19 pandemic had begun and social distancing measures were put in place.

Data collected from this doctoral study were examined for this article, to review the lived experiences of cancer patients who were referred for a clinical trial during the pandemic. Additionally, the article discusses the impact of the pandemic on cancer patients’ psychological wellbeing during this challenging period.



The initial aim of this study was to understand the experiences of cancer patients who had been referred for a clinical trial, before and after they had received an educational intervention. This article examines the data collected during the pre-educational interventional stage of this study between September 2020 and October 2021, which corresponded to the time span that the national COVID-19 lockdowns were in place in the UK.

Through this examination of the data the author aimed to understand the experiences of cancer patients referred for a clinical trial during the pandemic.


A convergent mixed-methods design was used in this study, to collect quantitative and qualitative data in parallel, analyse data sets separately, then combine and compare both sets of data. The intention was to obtain a more complete understanding of a problem and to authenticate one set of findings by comparing it with the other (Creswell and Plano Clark, 2017).

Semi-structured interviews were used to develop an understanding of newly referred cancer patients’ experiences of being referred for a clinical trial. Thematic analysis was used to examine interview transcripts and develop themes (Braun and Clarke, 2022).

The Generalised Anxiety Disorder Assessment (GAD-7) questionnaire was used to measure the anxiety and stress of cancer patients within this study. GAD-7 is a validated seven-item instrument that is used to measure or assess the severity of generalised anxiety and stress disorders (Snijkers et al, 2021). The GAD-7 score has seven questions and allocates scores of 0, 1, 2 and 3, to the response groups of ‘not at all’, ‘several days’, ‘more than half the days,’ and ‘nearly every day’ to each question. Scores from all questions are added together to give a total GAD-7 score (Snijkers et al, 2021).

Scoring parameters are 0-4 ‘minimal anxiety’, 5-9 ‘mild anxiety’, 10-14 ‘moderate anxiety’ and a score greater than 15 would be representative of'severe anxiety’ (Snijkers et al, 2021).

Mean GAD-7 findings were compared against themes developed from interviews to evaluate the patient experience. It was hoped themes from interviews would explain the levels of anxiety recorded within this patient group in more detail.

Ethical approval

Ethical approval for this study was obtained from the Health Research Authority in July 2020 (IRAS Project ID 279203).


Participants were identified from the cancer clinical trial research unit of a large regional cancer centre within an NHS foundation trust. Patients meeting the following criteria were included in the study:

  • Men or women aged 18 years and above
  • They had a confirmed diagnosis of advanced cancer (at stage 3 or 4). The criteria for being excluded from the study were:
  • Individuals under the age of 18
  • Patients who had previously enrolled in or taken part in a clinical trial.

Data collection

Prospective participants who were referred to a cancer clinical trial research unit and who met the eligibility criteria were sent an information sheet regarding the study before their initial appointment.

Two hundred patients were screened and then approached to participate in the study; 130 individuals agreed to take part. Thirty were interviewed and 100 completed the GAD-7 questionnaire. Questionnaires were collected as part of patients’ initial research appointments, while patients’ interviews were carried out at later dates that were convenient for them. The author conducted all the interviews within this study, which were done under social distancing regulations; this stipulated that both patient and author should wear a surgical mask and keep at least 2 metres apart.

GAD-7 was used to measure anxiety and stress in 100 participants. Patients who presented with a GAD-7 score of 10 or greater were referred to an NHS psychological therapies service. However, due to the pandemic, access to this service was limited.

No other patient-identifiable information was collected within this study, such as specifics of diagnosis, gender or age.

All interested participants gave written consent before any study-related procedures took place.

Data analysis

Transcripts from patient interviews (n=30) were reviewed and themes were produced through a method that included coding of transcripts through the employment of NVivo, a qualitative data analysis computer software package. Thereafter themes were agreed on through a review and debate of NVivo coding reports between the author and a senior mental health nurse.

A mean value of GAD-7 questionnaire scores (n=100) was reviewed against the GAD-7 scoring system (Snijkers et al, 2021). Both qualitative and quantitative data were combined to gain an insight into the patient experience.


The GAD-7 mean score was 13.77 (standard deviation=6.09), indicating from this sample that, on average, patients had moderate levels of anxiety. Three major themes emerged from the patient interviews to explain the experiences of cancer patients who were referred for a clinical trial during the first COVID-19 lockdown in the UK (Table 1).

Table 1. Themes developed from the 30 patient interviews
Theme Subtheme Statement example
Motivations for taking part in a clinical trial Altruism ‘Hopefully doing this means in 20 years’ time someone who gets the same cancer as me doesn't have to go through the horrible journey I have had to endure’Participant 3
Faith in referring doctor ‘I agreed, as I trusted my doctor, I've known him a long time and he has been great and I knew he was letting me know about this opportunity as it was in my best interests as I had no other treatment options at my local hospital’Participant 30
Hope ‘You're in a serious situation and how can you move forward with your life? I knew I would be going to hospital for the rest of my life, and this was my best option of getting a treatment and living longer’Participant 17
Worried about taking part Situational anxiety ‘I was already stressed a lot, and was very anxious; being asked to take part in a clinical trial didn't help this’Participant 13
COVID-19-related anxiety ‘Obviously, with social distancing, having to wear a mask all the time and with all this COVID-19 going on, this has caused me more anxiety about coming into a hospital to go onto the trial’Participant 22
Fear ‘In all honesty, I had genuine fear about going to any hospital appointment. I was scared that I might get COVID and it would make my cancer worse or kill me’Participant 27
Gap in referring centre education Minimal information through NHS regarding what a clinical trial is ‘Looking back at my journey, there could have been more information about what clinical trials are, who will look after me and support me’ Participant 17
Complex information ‘The doctor tried to explain what one [a clinical trial] was, but to be honest it was way too complicated to understand what might happen if I did take part in a trial’Participant 4
No patient resource to explain patient journey and what support there is ‘There were no booklets in hospital to explain any of this. I did ask, and I then looked online, and nothing really told me what happens to patients on a clinical trial and who looks after you’Participant 25

Theme 1: motivations for taking part in a clinical trial

A theme of ‘motivations for taking part in a clinical trial’ arose from the patient interviews. This theme unearthed three very different reasons why patients had decided to take part in a clinical trial. Three subthemes were identified: ‘altruism’, ‘faith in referring doctor’ and ‘hope’ as the main motivations for the patients enrolling in a clinical trial.

Reviewing this theme in more detail, altruism in this context meant that patients took part in a clinical trial knowing that it may be of no benefit to them, but that it might support the development of cancer treatments. ‘Faith in the referring doctor’ gives an insight into the level of trust patients place in doctors in making the right healthcare decisions for them, even when referring them for a novel area of health care such as a clinical trial. The final subtheme ‘hope’ expressed the optimism that patients had in making the decision to take part in a clinical trial, in that they viewed it as the best option to get a better treatment for their cancer, with the hope it would prolong their life expectancy.

‘I decided I wanted to go for a clinical trial as I thought it might help me, but it would help future cancer patients taking part in a trial. I know developing new treatments required people like me to take part in these things.’

Participant 29

Theme 2: worried about taking part

‘Situational anxiety’, ‘COVID-19-related anxiety’ and ‘fear’ were the three subthemes that came to light when reviewing the theme of anxiety from patient interviews. ‘Situational anxiety’ referred to being asked to take part in a clinical trial, which seemed to indicate this exacerbated the widespread anxiety that cancer patients already had. ‘COVID-19-related anxiety’ gave an insight into their feelings around going into hospital for a clinical trial, when social distancing measures were in place and they would have to attend appointments alone. ‘Fear’ was the third subtheme identified, which suggested that patients were fearful of going into hospital during the pandemic, due to the very real risk of being infected with the SARS-CoV-2 virus and contracting COVID-19.

‘I couldn't bring my husband with me to any appointments because of COVID. I could have cried when I was told this, my anxiety went through the roof, he is my rock.’

Participant 15

Theme 3: gap in referring centre education

The third theme that emerged from the data focused on the initial discussions patients had with their doctor about being referred for a clinical trial.

Within this theme, two of the subthemes indicated that there was a gap in educational resource provision. It highlighted that there were no educational resources available to newly referred patients to explain what the patient journey could entail within a clinical trial, either in an NHS facility or online.

‘I didn't get any information to take away from the doctor that referred me, and there was nothing at the hospital or on the NHS website to really explain what a clinical trial was.’

Participant 7

Data additionally suggested that, when doctors were having discussions with patients about being referred for a clinical trial, the information provided was often too complex.


The current study has provided an insight into some of the challenges cancer patients experienced during the pandemic while being referred for, and attending hospital appointments for participation in, clinical trials.

The mean GAD-7 score of13.77 indicated that, on average, patients had moderate levels of anxiety when attending their first research appointment. This finding suggests that out of the 100 patients who completed the questionnaire the majority (70; 70%) had generalised anxiety disorder, and needed referring to NHS psychological therapies services for treatment (Snijkers et al, 2021). However, this service was limited during the pandemic and only 10 patients were able access it.

When comparing findings from studies that used GAD-7 to measure the anxiety levels of patients with advanced cancer pre-pandemic, there is evidence to suggest that the levels of patient anxiety found in this study were higher than expected for this patient population (Naser et al, 2021). Pre-pandemic studies indicated that between 13% and 20% of advanced cancer patients would exhibit moderate levels of anxiety, based on GAD-7 scores recorded from individuals attending hospital appointments (Naser et al, 2021).

Reviewing the themes uncovered within the patient interviews provides an insight into the probable causes of moderate anxiety levels among patients. ‘Situational anxiety’ and ‘COVID-19-related anxiety’ were prominent subthemes that indicated the reasons why patients were feeling moderately anxious when attending their clinical trial appointments.

Research would suggest that the ‘situational anxiety’ theme discovered within this study is a common cause of anxiety within cancer patients (Pitman et al, 2018). Much of the literature on this subject has found that cancer patients are generally at a higher risk of increased levels of anxiety and stress, due to disease burden (Pitman et al, 2018). When presented with the choice of whether to participate in a clinical trial, the decision can increase cancer patient anxiety (Mazzocco et al, 2019). Patients are often confronted with a lot of information and sometimes unanswered questions, not long after a diagnosis of a progressing advanced cancer, which contributes to increased anxiety (Gregersen et al, 2019). Cancer patients who take part in clinical trials often report feeling initially vulnerable, as well as experiencing overwhelming emotions such as fear and anxiety, which have been attributed to misconceptions around the nature of clinical trials (Zhou et al, 2019).

In reviewing this further, theme 3, ‘Gap in referring centre education’, supports this as one probable cause of increased anxiety levels. This theme indicated that patients felt there was a gap in education provided by the doctor referring them for a clinical trial and, additionally, the information that was presented was often too complex.

The findings indicated that COVID-19 had an adverse impact on cancer patients’ psychological wellbeing when deciding to take part in clinical trials during the pandemic. The COVID-19-related anxiety theme indicates that social distancing regulations imposed during that period may further explain the moderate level of anxiety expressed in GAD-7 scores.

During the period over which data were collected for this study, cancer patients attending hospital for clinical trial appointments in line with hospital social distancing guidelines were not allowed to bring anyone with them. In normal circumstances pre-pandemic, cancer patients would be encouraged to bring a family member or friend to all of their clinical trial appointments for emotional support (Pennant et al, 2019). This type of support is seen as a key element of maintaining the psychological wellbeing of cancer patients. The fact of a family member or friend simply ‘being there’ is essential to help patients get through their emotionally challenging cancer journey (Pennant et al, 2019).

In essence, the presence of a friend or family member is seen as a positive strong social support system that the majority of cancer patients need when attending hospital appointments for treatment and discussions around the future direction of their care (Pennant et al, 2019). Clearly, stopping this patient support system during the pandemic had an adverse impact on patients’ anxiety levels.

The ‘worried about taking part’ theme, additionally suggested that patients had a ‘fear’ of attending hospital appointments due to the risk of becoming infected by the virus. Patients were concerned that the virus would make their cancer worse and that, as cancer patients, they were more at risk of dying from COVID-19.

A number of studies have indicated that both anxiety and fear increase psychological distress and sleep disorders, which in turn may contribute to depression (Duong, 2021).

The findings clearly paint a grim picture of what cancer patients had to endure when attending hospital appointments to consider taking part in a clinical trial during the pandemic. However, all of the participants in this study still made the decision to do so, despite the challenging circumstances.

The reasons patients still chose to attend these appointments against the backdrop of the COVID-19 pandemic, while many of them had a generalised anxiety disorder and a genuine fear of attending hospital appointments, can be explained within the ‘motivations for taking part in a clinical trial’ theme. Some study participants expressed altruistic motivations for taking part in research, expressing a desire to improve the future care of cancer patients by being part of a clinical trial and, in other cases, motivations revolved around having ‘faith in referring doctor’, in that they trusted the decision of the clinician referring them. ‘Hope’ was cited as one of the main reasons for wanting to take part in a clinical trial, in that this was potentially their last opportunity to get access to treatments for their cancer.


There are limitations to this study, which could be addressed in future research. The initial focus of the study was to review the experiences of cancer patients being referred for a clinical trial before and after an educational intervention. It was not initially designed to explore the experiences of patients referred for a clinical trial during the pandemic. As such, the focus of the patient interviews in the pre-interventional phase of this study centred on the level of education and understanding of clinical trials, rather than the pandemic.

Clearly, if the focus of patient interviews had been on COVID-19 and its impact, the study would have collected a greater depth and richness of qualitative data around the impact the pandemic had had on this patient population.

Limitations aside, the results of this study indicate the value of further research in this area, to gain a true understanding of how the pandemic impacted cancer care. Having a greater understanding of this impact may additionally lead to the development of interventions that may limit the potential negative effects of future pandemics. For example, one contributing factor to the moderate anxiety levels shown within by patients in this study was the fact they were unable to bring a friend or family member with them to appointments. The use of technology, such as video calls, may have reduced the severity of this challenge. The use of virtual patient appointments, online electronic consent and hybrid appointments have been shown to increase clinical trial appointment flexibility, reduce patient travel time, as well the risk of contracting COVID-19 but, at the same time, still allow friends and family to attend the appointments (Kirby, 2020).


Despite its small scale, the study provides insight into the experiences of cancer patients who were referred for a clinical trial at the height of the COVID-19 pandemic. It has illustrated the impact of social distancing, and how virus-related fear affected patients’ mental wellbeing.

There are key lessons to be learnt from the pandemic and there would be value in future work examining the impact it had on cancer patients. Developing a greater understanding of cause and effect may be key to adapting future healthcare services to reduce the potential repercussions of similar devastating events.

Key points

  • The pandemic had a psychological impact on cancer patients enrolled in the study, due to the effects of social distancing and fear of contracting COVID-19, which affected their decision as to whether or not to participate in a clinical trial
  • Patients’ motivations for taking part in a clinical trial during the pandemic included altruism and hope. Aspects that caused patients anxiety included the complex or minimal information conveyed to them about clinical trials
  • The experiences of the patients reported in this study and elsewhere provide lessons for future service provision, including how to adapt the care delivered during global health events such as a pandemic

CPD reflective questions

  • Consider what you could do to support cancer patients’ psychological wellbeing after the COVID-19 pandemic
  • Reflect on your experiences of caring for patients during the pandemic. Are there any lessons to be learnt that could improve future cancer patient care?
  • With reference to the themes explored in this study, can you identify any services or innovations that could have limited the effect of the pandemic on cancer care services?