The Trajectory of CAR T-Cell Therapy From the Perspective of Patients,Family Caregivers,and Nurses. A Multi-Center Qualitative Study Protocol

Abstract

Background

CAR T cell therapy is becoming increasingly important in the treatment of haemato-oncological cancers. Knowledge is available on the management of the main side effects and the possible late effects. On the lived experience of patients and their family caregivers and the experiences of nurse there is hardly any knowledge. Current studies show that patients experience that there was no alternative to the treatment decision, that monitoring after the administration of CAR T cells was stressful and that the occurrence of late effects was surprising for them.

Research Aim

The study examines the experiences of patients and their family caregivers during the trajectory of CAR-T cell therapy; from the decision-making process to the time after CAR-T cell therapy. It follows the main question: How do patients with severe haemato-oncological diseases, their supportive family caregivers and nurses experience and shape CAR T cell therapy?

Method

A qualitative study design using grounded theory by Charmaz. Data will be obtained using semi-structured interviews with patients and family caregivers and focus group interviews with healthcare professionals. The interviews are going to be recorded, transcribed and analysed. During the process of CAR T cell therapy, the patients and family caregivers interact with each other, with their social environment, with nurses and, when participating in the planned study, with the researcher. To integrate the data from different perspectives, the data will be compared and analyzed for differences and similarities.

Results and Conclusion

The results are expected to identify the experiences of patients, their family caregivers and nurses. Their needs and wishes for support contribute to the development of a care concept for CAR T cell therapy patients and their family caregivers.

Keywords

CAR T-cell therapy lived experience perspective patients family caregivers nurses grounded theory

Background

According to the International Agency for Research on Cancer (IARC, 2020), 19,292,789 people worldwide were diagnosed with cancer in 2020, and 9,958,133 people died from cancer. North America, Europe, Australia, and New Zealand are particularly affected. The IARC (IARC, 2023) predicts a global increase in cancer cases of almost 50% by 2040. In Germany, approximately 500,000 people are diagnosed with cancer every year (Robert Koch-Institut [RKI], 2021). Due to demographic change, the Robert Koch Institute (2021) predicts an increase in new cancer cases of approximately 23% by 2030. Haematological and oncological diseases such as leukaemia, lymphoma, and multiple myeloma will also increase. For many patients, these diseases are deadly. CAR T-cell therapy offers them a chance to survive.

CAR T-cell therapy is a type of immunotherapy in which the body’s own immune system is activated to fight cancer cells (Sathyanarayanan et al., 2015). In the chimeric antibody (CAR), an extracellular, a transmembrane, and an intracellular receptor are combined and added to the patient’s T cells during genetic engineering in the laboratory (Neelapu et al., 2018). For this process, the patient’s own T cells are removed by apheresis, processed and reinfused (McConville et al., 2017). The production of CAR T-cells is time-consuming, and patients often must undergo chemotherapy to bridge the waiting period (Lamprecht & Dansereau, 2019).

The main side effects of CAR T-cell therapy are Cytokine Release Syndrome (CRS) and Immune Effector Cells Associated Neurotoxicity Syndrome (ICANS) (Adkins, 2019; Anderson & Latchford, 2019). CRS occurs during the activation and proliferation of CAR T-cells in the patient’s system, during which cytokines are released and cause a systemic inflammatory response. The causes of ICANS are unclear. In some patients, CAR T-cells cross the blood-cerebrospinal fluid barrier and cause encephalopathy. Symptoms such as disorientation, hallucinations, delirium, tremors, somnolence, or seizures can occur (Adkins, 2019; Anderson & Latchford, 2019; McConville et al., 2017). To detect the first signs of CRS and ICANS at an early stage, patients should be screened at least every eight hours after reinfusion of CAR T-cells (Neelapu et al., 2018).

The close monitoring required during and after CAR T-cell therapy can pose challenges for patients. While patients have high expectations for the reinfusion of CAR T-cells, the actual procedure is unspectacular and takes little time (Bixby et al., 2023). The subsequent monitoring gives patients a sense of security, but often leads to problems with handling the cables and sleeping through the night (Bixby et al., 2023; Leinemann & Krutter, 2023). Family caregivers are an invaluable source of support for cancer patients (Berry et al., 2017). They support patients during their hospital stay, at outpatient appointments and therapies, and enable care in the home environment. At the same time, they are also affected by the cancer diagnosis, worry about their relatives, and need support themselves (Berry et al., 2017; Johannsen et al., 2022). Patients who have experienced few side effects often find protective isolation stressful and feel confined (Leinemann & Krutter, 2023; Stenson et al., 2023). To detect early symptoms of neurotoxicity and to initiate medical interventions to treat neurotoxicity (Christensen, 2018; Halton et al., 2017) as well as to give social support, nurses play an important role. In order to fulfil this role, they require knowledge of how the therapy works, how to manage side effects, and the competence to apply this knowledge in practice (Halton et al., 2017; He et al., 2023). Altogether, CAR T-cell therapy presents different challenges to patients, family caregivers and nurses, that they can master together.

Study Aim

The aim of the study is to investigate the experiences of patients and their family caregivers during the trajectory of CAR-T cell therapy; that includes the decision-making process, for the course and in the time after CAR-T cell therapy. In addition, the perspective of nurses in the care of patients will be explored. The results will serve as the basis for the development of a concept for the care of CAR-T cell therapy patients and their family caregivers and will contribute to the further development on theories of patients’ and family caregivers’ cancer therapy and side effect experiences.

Research Questions

The current state of research reflects the growing importance of CAR-T cell therapy in haematology and oncology. At the same time, there are only a few studies on the experiences of patients, their family caregivers and/or nurses. Therefore, the planned Ph.D. thesis addresses the following main research question:

How do patients with severe haematological and oncological diseases, their family caregivers, and nurses experience and shape the course of CAR T-cell therapy?

The following secondary questions will also be investigated:

How do patients with severe haematological and oncological diseases and their family caregivers experience and shape the decision-making process for CAR-T cell therapy?

How do nurses experience and shape the care and support of patients with severe haematological and oncological diseases and their family caregivers?

Literature Search and Originality of the Study

There is a high number of clinical studies and scientific articles on CAR T-cell therapy, focusing on the management of side effects and possible long-term consequences. At the same time, to the researchers’' knowledge, there are currently only a few studies on the process of deciding on CAR-T-cell therapy, the patient experience of the treatment, and the side effects and long-term consequences. The authors therefore decided to review the current state of research by conducting three reviews with different thematic focuses: the decision to undergo therapy, CAR-T cell therapy, and the symptom experience. Following, the results of these reviews are presented.

On the challenges and opportunities in shared treatment decisions for patients diagnosed with acute myeloid leukaemia (AML) a narrative review has been conducted. AML is an acute life-threatening disease, necessitating an immediate treatment decision following diagnosis. Patients are often in a state of shock following the diagnosis and lack the necessary knowledge to participate in shared decision-making (SDM) regarding their treatment options (LeBlanc, 2019; LeBlanc et al., 2022). Ten studies were included in the review. The main categories identified were diagnosis-shock, patients’ wishes and concerns, communication with health professionals, and decision-making aids. Patients frequently reported feeling overwhelmed by the information they were given and the urgency of the treatment decisions they were required to make (Bridges et al., 2018; Crawford et al., 2020; Richardson et al., 2021). Some studies identified patients’ individual wishes and concerns regarding the therapies’ side effects and long-term consequences. Communication between physicians and patients was not always sufficient or easily understandable for patients. Decision aids showed improved knowledge and facilitated patient participation in the decision-making process (Hildenbrand et al., 2021). Therefore, to help patients with AML better understand their disease, the use of decision aids should be increased and promoted. Discussions with physicians about therapy decisions could be split into two appointments so as not to overwhelm patients with too much information. Nurses can support the patient decision-making process by counselling patients on questions about their disease and treatment options. The necessity of SDM accompanies the patients from the moment of the diagnosis of AML and offers the opportunity to have their wishes and worries heard and considered.

A scoping review was conducted on the experience and management of CAR T-cell therapy and its side effects (Leinemann & Dunger, 2024). Five qualitative and one quantitative study, two reviews, one case study, and six other scientific articles were used. They originated mainly from the US, with two from China and one each from the UK and Canada. The analysis identified three main themes: ‘Experience of CAR-T cell therapy and side effects’, ‘Nursing management of side effects of CAR-T cell therapy’, and ‘Long-term effects of CAR-T cell therapy and nursing management’. The results show that patients and their family caregivers require different nursing support, education, and guidance during the individual phases of CAR-T cell therapy. The focus is on managing CRS and ICANS. Initial findings on the long-term effects of CAR-T cell therapy show that patients and their family caregivers continue to require follow-up support after they are discharged from the hospital. Nurses play an important role in the early detection of CRS and ICANS (Christensen, 2018). In addition, they need knowledge of CAR T-cell therapy, chemotherapy, and symptom assessment and management to provide comprehensive care for patients (He et al., 2023). Qualitative studies on the experiences of patients, family caregivers, and nurses can help to better understand the impact of CAR T-cell therapy on the everyday lives of the persons concerned.

All cancer therapies can cause side effects. These side effects can impair patients’ quality of life, and managing symptoms can be difficult in outpatient settings (Pedersen et al., 2012).The experience of individual or multiple symptoms is subjective for each patient (Humphreys et al., 2014). Side effects and long-term consequences of therapies have an impact on the everyday lives of cancer patients. A systematic qualitative review was conducted to promote understanding of the symptom experience in cancer patients and to obtain an overview of the current state of the research literature (Leinemann & Selakovic, 2023). A total of 35 studies on 10 symptoms, bodily changes and challenges associated with cancer therapies were included. The symptom and burden experience of the patients led to challenges in their everyday life; The patients searched for coping strategies and tried to integrate their experiences into shaping their future. To cope with their individual symptom and burden experience, patients require a regular symptom assessment and nursing support with their symptom management. Continuous and individual symptom management can help reduce uncertainty among (cancer) patients and facilitate changes (transitions) in the lives of cancer patients (Meleis, 2010; Mishel, 2014).

To date, there have been very few scientific studies on the lived experiences of patients, family caregivers, and nurses with CAR T-cell therapy. The planned qualitative study therefore aims to examine the lived experiences of the aforementioned persons during the course of CAR T-cell therapy and to combine the different perspectives into a holistic view.

Explanation and Justification of Method

A qualitative research approach was chosen to answer the research question. The study aims to investigate the experiences of patients, relatives, and caregivers and their interactions. Glaser and Strauss (2008) developed the grounded theory, a methodology for qualitative social research whose objective is to examine processual interactions and to develop concepts and theories that are anchored in the collected data. Since then, grounded theory has become established in qualitative social research and has been further developed by some researchers who have critically examined certain aspects of the methodology (Morse, 2010; Strübing, 2005).

Charmaz (1990) criticizes Glaser and Strauss (2008) for describing the process of theory development as objective and for arguing that researchers “discover” theory during data analysis. Based on social constructivism by Berger and Luckmann (2016), she describes data analysis and theory development as a dialectical process in which researchers are actively involved. In addition, the professional experience and prior knowledge of the researchers, their social background also influences their decisions in the research process, their interactions with the study participants, and the data analysis and theory development (Charmaz, 1990, 2014; Puddephatt, 2006). For this reason, the authors chose constructivist grounded theory according to Charmaz (2014) in order to remain open to the experiences of patients, family caregivers, and nurses and to jointly explore the experience of CAR-T cell therapy from different perspectives.

The epistemological approaches of the study are symbolic interactionism and social constructivism. Symbolic interactionism examines human interactions and communication through symbols in the form of languages (Denzin, 2019). According to Blumer (2013), symbolic interactionism is based on the following three fundamental principles: (1) People’s actions are based on the meanings they attribute to people, objects, and situations in their social environment; (2) meanings develop through mutual exchange and joint creation through interaction between people; (3) meanings are subject to continuous verification, comparison, and reinterpretation. For Blumer (2013), the process of social interaction cannot be studied using quantitative methods. To understand and analyse social interactions, researchers must approach the group of people being studied, observe them, and talk to them in order to understand them. Social constructivism assumes that social reality and knowledge are constructed by people through interactions and the sharing of experiences (Berger & Luckmann, 2016). Common knowledge regulates and organizes human societies. Access to common knowledge is subjective and depends on people’s social environment and experiences. To expand their knowledge, people share their experiences with each other (Berger & Luckmann, 2016).

Both approaches contribute to the study and influence the chosen method. The focus of the planned study is therefore on the subjective experiences of the participants in their joint interactions and their joint construction of meaning. The researchers are part of the construction process, co-create understanding and critically reflect on their positions (Charmaz, 2014). Constructivist grounded theory studies aim to explain human interactions and develop theories based on the content of the data (Charmaz, 2014). Unexpected results can contribute to theory formation through abduction, as researchers search for new explanations for these results (Reichertz, 2022).

Access and Sampling

CAR T-cell therapy is currently being carried out in 40 clinics in Germany (Novartis, 2024). All hospitals will receive a request asking whether they would like to participate in the study. The aim is to involve between three and six hospitals in this multicentre study. For the direct recruitment of study participants, gatekeepers will be appointed by the hospitals. In the case of patients and family caregivers, these could be the attending physicians, and in the case of nurses, the responsible nursing managers. Gatekeepers can prevent access to potential study participants, but they can also promote access if they are people whom the study participants trust, thereby facilitating researchers’ access to the field (Riese, 2019). Purposive sampling is used to recruit study participants who meet the inclusion criteria and other criteria, who will be developed during the research process (Ahmad & Wilkins, 2025).

The theoretical sampling method is used to determine the number of study participants among patients and family caregivers. In this method, the data material is analysed after the initial interviews to identify further research focuses, for which study participants are then specifically sought until theoretical saturation is achieved (Charmaz, 2014; Glaser & Strauss, 2008). Study participants can choose whether they would like to conduct the interviews individually or as couples. The anticipated goal is to interview at least 20-25 patients and family caregivers. For the focus group interviews, a group size of 5-8 people is desired in order to encourage an exchange of opinions among the participants (Lamnek & Krell, 2016). Theoretical saturation is also aimed for the focus group interviews. In studies with focus group interviews, information on the number of interviews required varies or is missing (Carlsen & Glenton, 2011). Some of the studies examined by Carlsen and Glenton (2011) indicate that 4-6 focus group interviews may be sufficient.

Inclusion Factors for Research Participants

The study includes different groups of participants. They all need to be over 18 years of age and must have a good command of the German language, Cancer patients who have been at home for at least 14 days after undergoing CAR T-cell therapy, and are physically and psychologically capable of participating in the study will be included. Family caregivers of patients who have undergone CAR T-cell therapy, and are physically and psychologically capable of participating in the study will be included. For the focus groups, the nurses should have at least one year experience in caring for patients during CAR T-cell therapy. In addition, all participants need to confirm their informed consent.

Data Collection and Analysis

The main focus of the study is on the lived experiences of patients, relatives, and nurses with CAR T-cell therapy. Intensive interviews are conducted to give study participants the opportunity to express their own themes and shed light on the topics of the planned research project (Charmaz, 2014). Charmaz (2014) differentiates between informative, investigative, and intensive interviews. While the focus of the first two interview methods is on obtaining accurate data, intensive interviews focus on the lived experiences of the study participants and the significance of their experiences. Based on the current state of research, a semi-structured interview guide with open-ended questions will be developed. The pre-formulated questions will not be asked in a predefined order, but will be adapted to the course of the interview (Atteslander, 2010). The interview guide ensures a flexible structure for the interviews and the research process by being iteratively supplemented, revised, and adapted (Charmaz, 2014). While participants in individual interviews can freely report their experiences, researchers conducting dyadic interviews must ensure that both participants have the opportunity to present their perspectives (Szulc & King, 2022). After the interview, the study participants and the researcher can reflect on the content of the interview and the interview situation in a follow-up discussion. The study participants are asked whether they would like to participate in the communicative validation of the results (Mayring, 2016). In addition, sociodemographic data relevant for the description of the sample is recorded in writing on a documentation sheet after the interview. The researcher records her impressions of the interview, methodological and thematic considerations, and any special features in a research diary.

The interviews are transcribed according to the rules of content-semantic transcription and enhanced content transcription. This ensures that the interview is easy to read and focuses on the semantic content (Dresing & Pehl, 2018). Transcription and data analysis are carried out using the MaxQDA software program. For evaluation using grounded theory according to Charmaz (2014), the memo function is used for initial coding and MaxMaps for focused coding (Friese, 2019). The data analysis process begins with initial coding, in which small units of data are grouped together as meaningful units and assigned codes to indicate their meaning. The next step is focused coding, in which frequently occurring and thematically related codes are used to form categories that are condensed into concepts during the data analysis (Charmaz, 2014). Each step of the data analysis involves a continuous comparison of the different cases and an interactive evaluation of the data. For the data synthesis of the different perspectives, the researcher plans to compare the codes of the patients, relatives, and nurses after analysing the data from the first individual and focus group interviews to identify differences, similarities, and approaches for further exploration in the research project, similar to the data integration used in mixed methods studies (Kuckartz, 2014). The data analysis will also consider the potentially differing healthcare structures of the respective hospitals as a possible explanation for varying experiences of patients, relatives, and nurses. For the purposes of constant comparison, the data will be integrated several times until the research project is completed.

Rigour

Charmaz (2014) suggests credibility, originality, resonance, and applicability as quality criteria for grounded theory studies. Credibility refers to the researchers’ application of the method. Aspects such as familiarity with the research subject, category formation, constant comparisons, and the logic of the conclusions drawn from the results are considered. Originality refers to the significance of the data collected and its contribution to the current state of research. Charmaz (2014) understands resonance to mean the relationships between categories, the consideration of deviating data, the search for meaningful connections, and whether the results reflect the experiences of the study participants. Applicability refers to the influence of the results on nursing practice and research and their contribution to expanding knowledge of the research topic. These quality criteria will be applied by the researchers in the planned study.

Researchers do not stand outside the society in which the phenomenon under investigation occurs; they may be potentially affected and have their own views and attitudes toward the phenomenon (Reichertz, 2015). Since the subjectivity of researchers cannot be completely ruled out, its potential can be utilized in qualitative social research by including it in the data analysis (Flick, 2017; Lamnek & Krell, 2016; Lincoln & Guba, 1985). The information that researchers obtain through communication and interaction with people in the field of research and the critical reflection on their own interactions and observations should also be included in the data analysis (Flick, 2017). To this end, the researcher will keep a research diary, follow protocols, and write memos. To comprehensively represent the dimensions of a social phenomenon in a specific context, the subjective experiences and attitudes of the researchers are also part of the object of investigation (Lincoln & Guba, 1985). These will be documented by the researcher in her memos and incorporated into the data analysis. In the research colloquia in the Ph.D. program with her fellow students, in discussions with her Ph.D. thesis supervisors, and in exchanges with other nursing scientists on data analysis, the researcher will critically reflect on her subjective experiences and attitudes and their influence on the research process.

Ethics and Data Protection

The planned study will be conducted in accordance with the Declaration of Helsinki (Shrestha & Dunn, 2020). Study participants will be informed in writing and verbally about the procedure and objectives of the study. Patients and their family caregivers are vulnerable groups who should not experience any unnecessary stress as a result of participating in the study (Schnell, 2013). The consent form will inform study participants that participation in the study is voluntary and can be withdrawn at any time without giving reasons and without any disadvantages arising from this. Patients and family caregivers can participate in the interview together. Patients and family caregivers who participate individually may bring a person close to them for emotional support. In the participating hospitals the researcher will ask whether patients and family caregivers who find the interview situation emotionally stressful can receive immediate psycho-oncological support. In addition to the potential stress, participation in the study could also have positive effects. Telling their own story can help patients and relatives to understand and interpret their experiences and to integrate them into their life story (Pennebaker, 2003). Participation in the study is voluntary for nurses and can be discontinued at any time without giving reasons and without any disadvantages. The ethics application was submitted to the Ethics Committee of the German Society for Nursing Science.

All data collected will be treated in accordance with data protection regulations in order to protect the privacy of study participants and prevent the transfer of data to unauthorized third parties (Liebig et al., 2014). The interviews are recorded with a recording device and transcribed by the researcher. For the scientific evaluation of the interview texts, all information that could lead to the identification of the interviewee is changed or removed from the text. The collected data is pseudonymized so that no conclusions can be drawn about specific individuals. After the interviews have been transcribed, the audio files will be deleted. Upon completion of the data analysis, the pseudonym list will be deleted so that the collected data is considered anonymous. In scientific publications, interviews will only be quoted in excerpts to ensure that the overall context of events cannot lead to the identification of the person by third parties. Personal contact details are stored separately from interview data and are not accessible to third parties. Once the research project has been completed, the contact details of the study participants will be deleted. All data collected in connection with the research project will be stored on an external hard drive with password protection. The hard drive will be kept in a secure location to which only the researcher has access. In the declaration of consent, study participants are informed about the use of the data collected from them and give their consent. They will be informed that they can revoke their consent at any time, in which case the data collected about them will be deleted. They will receive the contact details of the data protection officer at the respective clinic and the data protection authority to which they can submit a complaint in the event of a breach of data protection. If the data protection officers at the clinics participating in the study request further measures, these will be implemented accordingly.

Research Process and Challenges

Subsequently, the individual steps of the research process are outlined (s. Figure 1). In accordance with Charmaz’s Grounded Theory (2014), initial versions of the interview guidelines are created based on the current data available and the research questions, and study participants are recruited. After analysing the data from the first interviews, the interview guidelines will be revised, and attempts will be made to recruit study participants who represent further aspects of the phenomenon under investigation. This approach is repeated several times during the research process. The data from the individual cases are compared with each other and preliminary concepts are developed. The concepts will be further developed as the research process progresses. This process will continue until new data no longer illuminate new aspects of the concepts and it can be assumed that data saturation has been achieved.

Figure 1.

Graphic representation of the research process (Adapted from Charmaz, 2014)

A particular challenge of the planned study is bringing together the different perspectives. The study does not focus on the actual interactions that can be researched through participant observation (Strauss et al., 1985). Instead, it focuses on how the interactions are experienced by the paticipants involved, even if their perspectives may not be identical. To consolidate the data from the individual perspectives, the researchers plan to compare the codes of the patients, relatives, and nurses after analyzing the data from the first individual, dyadic and focus group interviews in order to identify differences, similarities, and approaches for further exploration in the research project, comparable to the data integration used in mixed methods studies (Kuckartz, 2014). In the process of continuous iterative comparison, the data will be aggregated several times until the research project is completed.

Footnotes

ORCID iD

Verena Leinemann

Ethical Considerations

The ethics application was submitted to the Ethics Committee of the German Society for Nursing Science.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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