Advances in early diagnosis methodology and novel anticancer treatments have seen survival rates improve for most cancer types (Ramirez et al, 2021). It is estimated that about 2.5 million people are living with and beyond a cancer diagnosis in the UK, a figure that is likely to increase to 4 million by 2030 (De Vincentiis et al, 2021). Incidences of patients presenting with advanced disease in some cancers remains high; this has been attributed to late diagnosis and lack of efficacy of current anticancer treatment options (Lheureux et al, 2019). It is projected that the COVID-19 pandemic will significantly increase cases of patients presenting with advanced cancers in the UK as a result of delays in diagnostic tests, and bring challenges due to the consequent backlog within routine diagnostic services (Maringe et al, 2020).
Efforts to advance the current landscape of cancer care and cancer treatments focus on clinical trials (Tolaney et al, 2021). Clinical trial designs are generally categorised into four phases. Phase one and phase two trials are regarded as early phase research, the first steps in treatment development, with phase three and four categorised as late phase research, the final phases (Tolaney et al, 2021). Clinical trials are central to discovering new types of anticancer treatments, and are equally important in uncovering methodologies for detecting and diagnosing disease, eventually leading to improvements in patient care (Tolaney et al, 2021).
In cancer research, cancer research nurses (CRN) have a crucial role in delivering experimental treatment, care management and patient advocacy during clinical trial care pathways that are often complex and emotionally challenging for patients (McCabe et al, 2019). Cancer is a unique area of clinical research in that it does not involve ‘healthy’ volunteers (Vickers, 2018). Therefore, in this specialty, it is fundamental for research nurses to have high levels of competency in terms of their clinical skills, cancer nursing care and communication skills, to ensure optimal patient care (Ness, 2020).
Background
In 2020, Cancer Research UK (CRUK) held an education and networking event in Birmingham as part of its ongoing Excellence in Research Programme aimed at supporting and further developing the CRN role in the delivery of cancer clinical trials.
At the event delegates attended workshops exploring different aspects of the CRN role (https://tinyurl.com/5n8ezpf8). Within this forum, nurses could share experiences, opinions and knowledge. Workshops covered topics that were pertinent throughout the patient journey in clinical trials, with the overall theme being to explore and share CRNs' experiences of caring for cancer patients within this area of nursing.
The findings and discussion presented in this article were developed from information provided by delegates attending one of the workshops. This workshop focused on CRNs' experiences of managing cancer patients' expectations of taking part in a clinical trial. It also looked at what CRNs valued as the key elements of effectively managing and supporting patients when they had clinical trial treatment side-effects.
Early and late phase cancer research
In a cancer research setting, the majority of patients who take part in early phase (phases one and two) clinical trials have exhausted all standard treatment options. This is usually because of patients' advanced stage of cancer and the low response rates for treatments at this stage – in the context of third-line and fourth-line options – that can be prescribed in line with National Institute for Health and Care Excellence (NICE) guidelines (Halpern et al, 2019). Early phase clinical trials concentrate on observing how a novel treatment affects the human body and how it should be administered. Furthermore they develop a safety profile, in terms of toxicity, and identify safe dosage levels (Vickers, 2018). Early phase clinical trials generally have low numbers of patients recruited into them. Often the treatments administered at this stage are ‘first in human’ trials. In early phase cancer research trials, it may also be the case that it is the first time a treatment is being used for a particular type of cancer (Vickers, 2018). Early phase oncology trials are primarily delivered in a network of experimental cancer medicine centres across the UK. These centres have specialist early phase research medical consultants and CRNs, who play a vital part in the delivery and clinical care of patients in experimental anticancer treatments. These centres are fundamental to the first step of developing new treatments for cancer patients (Experimental Cancer Medicine Centres Network, 2022).
Experimental treatments that have gained sufficient efficacy data within the early phase will progress to late phase (phase three and four) clinical trials. These types of trials have much higher numbers of patients recruited into them than early phase trials. They aim to compare investigative treatments against or in combination with gold standard of care treatments, while developing a larger side-effect profile of treatments (Vickers, 2018). In a cancer setting, this phase identifies which treatment works better for a particular type of cancer, as opposed to early phase, where the majority of trials are for any type of cancer (Vickers, 2018). Due to their design, patients eligible for late phase trials will have existing standard of care treatment options available. Late phase clinical trials are generally delivered in standard of care areas, such as chemotherapy or outpatient departments, within a hospital setting (Vickers, 2018).
Burden of cancer on clinical trial patients
Cancer patients' diagnosis and stage of disease will determine which phase of study they may be eligible for, and thus influence their expectation of benefit (McCabe et al, 2019). Late phase trials, for example, are often offered to patients as a first-line treatment option (Vickers, 2018). The experience of managing these patients' expectations and care vary considerably from those patients considered for entry into early phase cancer clinical trials; the latter are only offered to patients with advanced disease, who have no other treatment options available to them (McCabe et al, 2019). In many cases, patients in early phase trials will have had multiple lines of treatment before consenting to taking part in such trials (McCabe et al, 2019), and will have experienced significant debilitating treatment side-effects from chemotherapy and radiotherapy, such as fatigue, increased risk of severe life-threatening infection, and pain and skin damage (Ludmir et al, 2019). The impact of these treatments can persist for years and may include lymphoedema, mobility issues, bladder and bowel problems, persistent incontinence, infertility and psychosocial problems, and fear of recurrence (Ludmir et al, 2019).
Investigations around the psychological impact of cancer have shown that cancer patients are likely to experience high levels of depression and anxiety, as a consequence of disease burden (Pitman et al, 2018). The psychological impact of cancer often transcends to family members and carers of patients and it has been shown that, as disease progresses, anxiety and stress levels in this group also increase (Li et al, 2018). It has been suggested that a major depressive disorder develops in around 10% of patients (Ludmir et al, 2019). This can further reduce a patient's quality of life by increasing symptom burden and decreasing physical and social functioning (Unger et al, 2019).
CRNs working within a cancer research setting, in particular within early phase cancer clinical trials, will witness first hand the effects of prolonged and persistent cancer treatments on the patients being referred. Research indicates that cancer clinical trial patients often arrive for a clinical trial with heightened anxiety, expectation, and a sense of hope, but their ability to function day to day has clearly been compromised by their experience of disease, treatment, and its consequences (Li et al, 2018).
Informed consent
In clinical research, informed consent is regulated by good clinical practice, a global set of ethical and scientific quality standards for designing, conducting, recording and reporting clinical trials that involve human participation (Vickers, 2018).
The informed consent process ensures that patients are aware of the potential risks and benefits of taking part in a clinical trial (Vickers, 2018). This is often a very emotional and complex process, as patients are faced with a serious diagnosis and offered multiple experimental cancer treatment options (Burks and Keim-Malpass, 2019). Exploration of informed consent within cancer research suggests that increased emotional stress as a result of disease burden adds to the difficulty patients face in comprehending what clinical trials may entail (McCabe et al, 2019). The majority of patient confusion during the informed consent process is around understanding that trials are voluntary, the actual availability of other treatments, trial randomisation, uncertain health benefits, and unclear risk of treatment side-effects (Burks and Keim-Malpass, 2019). An effective informed consent process ensures that patients understand all of these areas of participation and the full extent of what they are agreeing to participate in prior to initiation of any experimental treatments (Burks and Keim-Malpass, 2019). Nurses play a critical role within this process, as patient advocate, assessing patients' health literacy levels and ability to understand complex information and tailoring education approaches to ensure patients are fully aware of the novel patient journey they are about to begin (McCabe et al, 2019).
Side-effect management
With any anticancer treatment it is inevitable that patients will have side-effects associated with treatment. In licensed anticancer treatments, guidelines to side-effect management are freely available for health professionals. These resources are developed through a body of knowledge gained through clinical trials (Zhou et al, 2019).
In many areas of cancer research, CRNs are managing side-effects of experimental treatments for which there are no guidelines, only ‘expected’ drug reactions. Indeed, a large element of early phase trials is to develop this body of knowledge, through recording any side-effects patients may have during trial treatments. Developing guidelines for managing and reducing these reactions are critical to future patients' wellbeing (Zhou et al, 2019).
Method
This evaluation used a content analysis approach to examine reflective experiences from 50 CRNs who attended a workshop at the 2020 CRUK Excellence in Research Programme event.
Through group work and discussions, CRNs' reflective experiences were captured by workshop facilitators around three topics:
- Patient expectations when consenting to trial participation
- The role of the clinical research nurse in supporting patients with their side-effect management
- Exploring different strategies for appropriate side-effect management support
A summary of points generated by facilitators from reflective CRN experiences around each of the three topics were reviewed, and themes were developed and investigated. Content analysis enabled the development of themes through the coding of content produced from CRN reflective experiences, with each of the themes generated discussed for validity and reliability for the identification of themes (Assarroudi et al, 2018).
All health professionals gave their permission for any data collected at the event to be used for service evaluation and publication – this was approved by CRUK.
On review of Health Research Authority guidelines this study did not randomise participants to different groups, no study protocol was written to demand changing treatment/care/services from accepted standards for any of the patients/service users involved. This work was not designed to produce generalisable or transferable findings, it was a retrospective review of reflective experiences captured in a workshop setting by facilitators. Therefore formal research ethical approval was not required, however, ethical principles were adhered to in the collection, storage and use of the data collected.
Themes identified and discussion
Table 1 shows four themes that were uncovered when CRNs discussed what patients' expectations were when going through the informed consent process to take part in a clinical trial.
Table 1. CRNs' views around patient expectations when consenting to trial participation
| Themes | Examples of attendee responses |
|---|---|
| Altruism |
|
| Communication |
|
| Educational resource |
|
| Optimism |
|
Patient's motivations for taking part in a clinical trial
The themes of ‘optimism’ and ‘altruism’ give two opposing insights into what CRNs see as reasons for patients enrolling into clinical trials within cancer research. Responses from the optimism theme illustrate that CRNs consider that some patients see clinical trials as ‘hope’, and as an opportunity to gain access to life-saving treatments. Research would indicate that this is often a misconception within cancer research, especially within early phase clinical trials where the primary aim is to gain new knowledge of drug toxicity and identify safe dosage levels (Vickers, 2018).
‘Altruism’ indicated that CRNs felt that some patients understand that being involved in research may not benefit them, but they want to take part to improve future cancer patient care. Reviews into altruism among patients taking part in cancer research suggest that altruism and self-interest are probably contingent on each other, which may complicate nurses' true understanding of patients' motivations for taking part in cancer clinical trials (Olsen et al, 2020).
Regardless of patients' motivations, these two themes demonstrate the importance of ensuring that patients are fully aware of why the research is being undertaken and why they are being asked to take part, so that false expectations are not established (Taylor, 2018).
CRNs' approaches to managing patient expectation
The communication theme emphasised the importance of nurses being clear, concise and honest, and using patient-friendly language when managing expectations when cancer patients are consenting to taking part in a clinical trial. This theme highlights the importance of an individualised approach to informed consent, translating complex information into lay language for patients and family members, so they can fully understand the implications of taking part in a clinical trial (Turnham et al, 2020).
The ‘educational resource’ theme gives an insight into what kind of resources are important in managing patient clinical trial expectations, such as well-designed consent forms written in patient friendly language. From this theme, some of the responses illustrated that CRNs consider that there is a potential gap in current patient educational service provision: ‘NHS needs to improve patient understanding of clinical research’ and ‘Generic info to help patient with decision making’. These views are supported by a systematic review considering the informed consent process, which emphasised that the level of patients' knowledge gained from informed consent is frequently inadequate and that additional educational interventions need to be developed (Burks and Keim-Malpass, 2019).
Reflective discussions uncovered some strong themes around what CRNs recognise as important elements in their roles in managing patient clinical trial treatment side-effects (Table 2).
Table 2. CRNs' thoughts around the role of the clinical research nurse in supporting patients with their side-effect management
| Themes | Examples of attendee responses |
|---|---|
| Relationships |
|
| Education |
|
| Communication |
|
| Clinical expertise |
|
The importance of CRN–patient relationship
The relationship theme (Table 2) indicates that CRNs view the patient-nurse relationship as key to the management of treatment side-effects. Knowing your patient is a vital component in all areas of nursing practice, and it is essential that nurses have the ability to develop a good understanding of their patient's general health needs and know who they are as a person. Developing mutual trust is key to optimised patient outcomes, even within these emergency situations (Jivraj et al, 2018).
Patient understanding of trial treatments
Similar to themes in Table 1, themes of education and communication came to light through CRNs' reflective discussions: these are important factors in supporting patients with their side-effect management (Table 2). On closer inspection, CRNs' responses focused on viewing their level of understanding around trial treatments and potential drug reactions as critical to side-effect management. In terms of education, the focus was on the need for CRNs to have high-level knowledge of potential treatment side-effects, and that patients are given the correct amount of education around side-effects to aid their management. Echoing the previous communication theme, CRNs regarded lay language (‘no jargon’) and treating patients as individuals as central to supporting patients during side-effect management.
Clinical expertise
A clear running theme within this topic was clinical expertise. Responses within this theme may suggest there were strong views that CRNs should be, or be working towards, an advanced practitioner in terms of clinical skills and knowledge of experimental treatments, for which in all likelihood there is no documented side-effect profile (Vickers, 2018). They would also need to have a high level of competency to react to and manage emergency situations, such as the management of potential side-effects, highlighting the very clinical nature of CRNs' roles within clinical trials.
In addition to discussions around supporting patients with their side-effect management, CRNs discussed side-effect management further, in particularly what they perceived to be best strategies to achieve this (Table 3). This reflective discussion focused on the different strategies that nurses could employ to help support patients in managing side effects.
Table 3. CRNs' opinions on the best strategies for appropriate side-effect management support
| Themes | Examples of attendee responses |
|---|---|
| Environment |
|
| Communication |
|
| Patient trust |
|
| Service improvement |
|
| Patient comprehension |
|
Appropriate area of care and resources
The environment in which the patients are cared for was highlighted as an important theme (Table 3), especially with regard to ensuring patient safety during their participation in a clinical trial and in the management of drug reactions. Within side-effect management, the importance of an effective and easy-to-access triage service for all patients to avoid missing vital safety information was highlighted as important for all clinical trial patients.
CRN discussions around having the correct resources in a clinical trial area highlighted the need for CRNs and medical staff to have immediate access to appropriate protocols and safety information relating to investigational medicinal products as a key strategy in clinical trial side-effect management.
Communication and assessment
The importance of good relationships and effective communication between patients and CRNs remained a running theme throughout the workshop and within this discussion topic (Table 3). Clearly effective communication during what must be a time of huge anxiety for patients and their families cannot be underestimated, as this helps to build trust, and increase understanding (Li et al, 2018).
The findings revealed that CRNs thought that building trust between patients and family members through honest conversations, with the addition of proficient nursing assessment, led to an increased willingness of patients to report problems, which aided trial treatment side-effect management.
In addition, CRNs identified proficiency in assessing patients during side-effect management to be of paramount importance, with additional suggestions that it could be improved through the use of technology, which could capture information in real time and could lead to better patient care, as well as improved service delivery.
Limitations
The information that was used for this article was gathered from a CRN conference, this pre-existing data was not collected to address a specific research question.
Data collected from CRNs during this process was brief, due to the time constraints of the workshop, which brings about limitations around the quantity of data that was analysed and the need for further research around this area.
The findings from this work illustrate the need to develop this work further through a specific research methodology, which would have allowed a greater depth of information for review and analysis.
Conclusion
The findings discussed give an insight into what CRNs perceive as cancer patients' reasons for wanting to participate in clinical trials. The two patient motivations illustrated, optimism and altruism, present two very different reasons as to why they decide to take part in cancer clinical trials. It also highlights the importance of ensuring patients fully understand why they are being asked to participate in a trial, the purpose of the research being carried out, and the potential benefits and risks of taking part.
CRNs have an important role within the informed consent process to ensure patients and their families have realistic expectations of what clinical trials offer. To achieve this, and also when supporting the management of side-effects of trial treatments, clearly CRNs view an important aspect of their role is to be able to translate complex clinical trial terminology and procedures into patient-friendly language.
Developing trust and good relationships with patients within cancer clinical trials is as important as it is in any other area of nursing to optimise patient healthcare outcomes (Jivraj et al, 2018). From the findings discussed, CRNs clearly valued good patient relationships, education and communication to the extent that they thought that it enabled them to support patients through the informed consent process, and allowed them to effectively manage clinical trial treatment side-effects.
The findings, based on CRN experiences, give an understanding into aspects of the role nurses have within cancer clinical trials, what patient clinical trial expectations are and strategies on how best to support patients within this area of nursing.
KEY POINTS
- Research nurses play a critical role in caring for, and supporting, cancer patients during their often complex and challenging journey in clinical trials
- Understanding cancer patients' motivations for taking part in a clinical trial is key to managing their expectations of what benefits a clinical trial may offer them
- Nurses play an important role in ensuring patients fully understand why they are being asked to participate in a clinical trial, including the potential benefits and risks
- Within clinical research the nurse–patient relationship is key to the management of potentially unknown treatment side-effects
CPD reflective questions
- Managing patient expectation in cancer research is very important in ensuring that patients and their families understand what the purposes of clinical trials are. What do you think the implications would be if this were not managed correctly?
- As a nurse, what would you do if you thought that taking part in a clinical trial was not in the best interests of the patient?
- Can you identify the likely challenges in monitoring for, and managing, unknown treatment side effects? What would be your approach?