Изучение психологического воздействия и опыта в области здравоохранения пациентов, живущих с рефрактом тройного класса, множественным миеломой: исследование интерпретирующих феноменологических исследований.

STRENGTHS AND LIMITATIONS OF THIS STUDY

This study used interpretative phenomenological analysis to enable detailed exploration of patient lived experiences.

Patient and public involvement through a Service User Advisory Group enhanced methodological validity and reduced researcher bias.

The sample of all white British participants may restrict generalisability to ethnic minority groups.

Introduction

Multiple myeloma (MM) is a chronic haematological malignancy caused by the proliferation of malignant plasma cells in the bone marrow and the overproduction of monoclonal antibodies. 1 MM can cause significant psychological burden for patients, including feelings of hopelessness and fear of relapse, making it difficult to manage. 2
3 In the UK, over 33,000 people are living with MM. 4 A common symptom of MM is bone pain, a symptom that can impair the sleep and physical activity of patients, leading to decreased health-related quality of life (HRQoL). 5 Developing supportive interventions to resolve the many challenges of living with MM is essential to improving patient HRQoL and an international research priority. 5
6

While there remains no cure for MM, three major classes of drugs and a haematopoietic stem cell transplantation aim to control the disease, which may result in periods of remission. 7 Classification of myeloma depends on the line of therapy a patient has received and their response to treatment. For example, patients who progress on their initial therapy and require a new line of treatment are classed as ‘relapsed’, while those who have not responded to treatment or progressed within 60 days of initiation of a new therapy are classed as ‘refractory’. 8 Patients who have not responded to or have relapsed after all three major classes of treatments are classified as triple-class refractory (TCR) MM. 9

As the disease advances, haematologists can find it increasingly challenging to effectively discuss a patient’s physical, psychological and social needs, particularly during relapse. 3 This is especially important for TCRMM patients as they often have additional concerns regarding their future and lack of available treatments. 10 According to a national UK survey, patients want more personalised and targeted treatment regimens with fewer long-term side effects. 11
12 The psychosocial impact of TCRMM, coupled with the need to acquire more information at each relapse and adjust to the worsening prognosis, causes significant uncertainty for patients nearing the end of the treatment pathway; as is the case for patients who are TCRMM. While studies have examined the MM patient experience at different timepoints separately (i.e. at diagnosis, each line of therapy and relapse), 10
13 an in-depth examination of the cumulative experiences of TCRMM patients remains unexplored.

The current study examines pertinent timepoints in the experiences of TCRMM patients at diagnosis, relapse and remission, during monitoring, treatment and at the point where no further standard of care treatment options were available. This is the sub-analysis of a wider qualitative study also involving newly diagnosed and double-class exposed patients.

Methods

Study design

An exploratory, qualitative study design was used to obtain in-depth data on lived experiences, through semi-structured interviews with a purposive sample of patients with TCRMM. The Interpretative Phenomenological Analysis (IPA) 14 method examines the value of subjective experience and the meaning of these experiences across individuals, allowing for nuance, convergence and divergence.

Patients

Patients were recruited via Myeloma UK between February and July 2023 using the following approach: (1) details of the study were shared through Myeloma UK social media and e-newsletter; (2) a randomly selected sample of 300 people who consented in writing received an email outlining the study; and (3) a post was placed on Myeloma UK’s Forum webpage. Interested individuals emailed the recruiters, Just Worldwide, who shared the participant information sheet, consent forms and organised a call to assess eligibility according to the inclusion criteria. Interviews and demographics, including gender, age, employment status, ethnicity, geographical region and treatment history, were collected. Thereafter, an interview with patients and Customer Faithful was arranged. All patients were given a unique study ID number to preserve anonymity. Patients were reimbursed in line with industry fair market value.

The study recruited participants with a diagnosis of TCRMM within 6 months, and up to more than 5 years from the time of study participation in 2023. Inclusion criteria therefore included: Patients with MM that had relapsed and were refractory to all three major classes of MM treatment: immunomodulatory drugs, proteasome inhibitors, anti-CD38 monoclonal antibodies, aged ≥18 years, and UK residents.

Data collection

The systematic approach of IPA 14 was used following a semi-structured interview schedule (see online supplemental material 1 ). This was developed to remain open and exploratory. 15 Patients were encouraged to lead the discussion, focusing on their lived experiences, with probes used to gather further detail. After the interview, participants were debriefed, informed of the dissemination plan and provided with contact details for questions or concerns. Patients were signposted to Myeloma UK for additional support if needed. Audio-recorded interviews lasted 52–101 min, were transcribed verbatim, de-identified, and included dialogue expressions (eg, pauses, laughter). Recruitment continued until data saturation.

Data analysis

Transcripts were analysed following the IPA approach, 14 an appropriate methodology for examining complex, ambiguous and emotionally laden topics. Linguistic, descriptive and conceptual notes were recorded alongside each excerpt of the transcript to aid the development of personal experiential themes, which were abstracted through interrogation of emergent themes and information power for each account. 16 Cross-case analysis was undertaken to examine convergence and divergence across the sample and develop group experiential themes; themes present across most of the sample represented key aspects of the experience. 14 This approach identified themes that captured important elements of patient’s experiences, including crucial unmet needs (see online supplemental material 2 ). Researchers maintained a reflexive perspective throughout the study, continually challenging themselves to ensure the voice of the participant was the central focus.

Methods to ensure rigour

To ensure trustworthiness of the study findings, credibility, transferability and confirmability were taken into consideration. 17 To support transferability and confirmability, Patient and Public Involvement (PPI) was embedded throughout the study development, conduct and analysis.

The appropriateness of the sample size was guided by the information power of a sample for qualitative interview, including the rich dialogue, established theory, purposive and narrow specificity of IPA. 18 All interviewers had significant training and experience in conducting studies using IPA as the methodological framework. 19
20

Patient and public involvement (PPI)

Prior to ethics, the study design, information sheets and written consent forms were reviewed and revised through engagement with Myeloma UK’s Patient and Carer Research Panel, consisting of volunteer patients and carers who provide opinions on research. A separate Service User Advisory Group (SUAG) of MM patients and carers was developed by Myeloma UK. RH presented the study design and results to the SUAG and feedback was collated and implemented by RH (see online supplemental material 3 ).

Results

69 people responded to the call for participation in a wider study involving newly diagnosed MM (NDMM), DCEMM and TCRMM patients. After screening, ten people with TCRMM met eligibility for participation and were invited to join the study; three withdrew from participation (reasons unknown) and seven consented in writing. Ages ranged from 41 to 81 years old ( M =60 years, 3 months, SD=15 years). All demographics are shown in table 1 .

Table 1 Demographics. Participant Age Employment status Gender Ethnicity Time since diagnosis UKPT57 late 60s Retired Male White British >5 years UKPT56 80s Retired Male White British 6–12 months UKPT53 60s Retired Female White British >5 years UKPT48 late 60s Retired Female White British >5 years UKPT47 late 40s Long term sick Male White British 6–12 months UKPT05 40s Part time Male White British 1–5 years UKPT68 50s Part time Male White British >5 years

Demographics.

Three themes are presented which capture key challenges for those with TCRMM: (1) Matching psychological support to specific moments , (2) Finding a voice in treatment decisions , and (3) Learning to navigate clinical trials . In assessing the validity of themes, plausibility was defined as the prevalence of themes being exhibited by at least half the patients in the study (see online supplemental material 4 ).

Matching psychological support to specific moments

Patients reflected on the insensitivity of the information provided and lack of tailored psychological support to manage the unsettling prognosis and resulting loss of identity:

The 1 st or 2 nd appointment at the hospital they mentioned it was terminal, and I was having to sign up to palliative care. I was horrified at that… shocked, really upset me, just the use of that terminology right early on. (UKPT48)

The initial information provided to patients via healthcare professionals (HCPs) at diagnosis was perceived as a significant stressful life event, particularly given the language used at diagnosis (‘terminal’). Communicating using this terminology caused a significant increase in levels of anxiety for patients, who often had distressing preconceptions about the terminal nature of cancer:

At the time I had anger, disappointment, I had immense worry because every time I've ever spoken about cancer it was always death, everybody around me it was always death, it was just something that we never talk about. I've got nobody close to me with a cancer, so I couldn't really talk about it. (UKPT47)

Patients detailed a range of fluctuating emotional experiences over time, including deep anxiety and isolation. Several patients had a desire to talk more freely about their illness, but felt unable to do so, as the topic of cancer and death was viewed as a taboo. Coming to terms with distanced social relationships due to a fear of cancer was typically referenced as a long-term process they worked through in isolation:

But wider family, some of them think you're going to die next week and they just don't bother ever coming to visit you. They don't realise that you are a human being still, it’s just really strange. It’s been a very upsetting thing for me to actually cope with that. I think it’s taken me the full 7 years to actually understand what’s going on and to actually deal with that psychologically, yeah. (UKPT48)

Other patients were able to develop successful coping strategies over many years to overcome their fear of relapse and uncertainties over remission:

I don't think I gave myself in the old days, I didn't give myself a lot of care. I now look at life in a very different way. The biggest difference is I'm not afraid of anything. Anything can happen and I’ll deal with it in whatever way I deal with it, but I'm not afraid of anything. And I'm from that point of view I'm grateful for myeloma because it has left me in a place - it’s weird - I'm grateful for myeloma, I’m grateful for lockdown, because it made me re-evaluate an awful lot of stuff. (UKPT53)

Three TCRMM patients pinpointed the emotional impact of repeated and long-term exposure to monitoring (i.e. paraprotein blood test), both during treatment as well as in remission. During treatment, patients perceived blood tests as controlling, causing significant uncertainty and associated psychological burden:

You end up in that phase of uncertainty while you’re still on treatment but the markers are coming up again…you’ve then got to deal with what’s next. (UKPT05)

During this ‘phase of uncertainty’ this patient was concerned about the changing nature of their disease and the delicate balance between treatment efficacy and uncertainties about the availability of future treatment options. For patients who had received psychological support from their haematologist, it was considered limited in scope across the patient journey and undervalued clinically:

Psycho-oncology is such an undervalued aspect of looking at a cancer situation. Training in doctors - it only just scratches the surface of what is such a vitally important part of the whole package. (UKPT57)

Inclusion of Psycho-Oncology services was seen as a key part of the overall package of care with the potential to remedy the emotional burden of diagnosis and unexpected shifts between remission and relapse.

Finding a voice in treatment decisions

Patient narratives highlighted how central patient information was to shared decision-making (SDM). In some cases, healthcare teams made decisions on behalf of patients, removing patient agency and unintentionally minimising their need to engage in their own healthcare:

I can't remember the last time I had a really decent discussion with a doctor, it’s like being on a treadmill. I’ve even had a doctor say to me at one time… you just worry about getting better, I’ll worry about what treatment you’re to get… But you can't help but worry about the treatments you get and [what] you hear about things. (UKPT48)

In these cases, patients perceived a lack of SDM as undesirable and at times patients felt dismissed. Consequently, patients felt treatment decisions were out of their control, leaving them in an intense state of emotional turmoil.

Engaging in SDM during consultations improved HRQoL of patients, exemplified by patients’ use of inclusive language (ie, ‘we’). Collaborative discussions were transformational and acted as a catalyst that moved patients from a ‘recipient’ of care to their own advocate:

And I went back…I kept going back for monthlies with the consultant, we tried lowering the dose, we tried spreading the Dex out over a longer period of time. And then I stopped, I said, I cannot sustain this, it’s depleting me that much and stopped for a couple of weeks. And the contrast just in that couple of weeks of stopping the treatment was so stark, I was back to some degree of functionality, cognitively and physically, and the sense of humour returned, I could be active, I could do things. (UKPT68)

By engaging equally in consultations to optimise treatment and reduce side-effects, patients perceived sense of control over their own lives improved, preserving important aspects of their self-identity and HRQoL.

All patients described the burden of treatment side effects and their desire to mitigate them. Attempts to lessen or manage side effects were often framed in HRQoL outcomes:

There’s always been steroids, but if I can get them on Tuesday, it means you’re past [mood swing side effects] before the weekend. Dealing with the kids…yeah, it’s not the greatest version of Dad…I’d rather…shield them from that, it’s kinder for everyone. (UKPT05)

Reflecting on adjustments to the timing and dosage of steroids, this patient felt they could maintain their parental role. The use of the words ‘kinder for everyone’ reflects the wider impact this treatment has on the patient’s family dynamic, rippling the disruptive impact of side-effects onto other family members.

Learning to navigate clinical trials

Two patients had participated in clinical trials (CTs), while another was waiting for enrolment. Patients reported challenges in accessing clear information and understanding complex eligibility criteria relating to CTs. Increased risk of early mortality and a sense of urgency were also prominent at this stage of their disease:

Everything on my mind is where are the next treatments? How quickly are the next treatments coming? How quickly can we get them through the system? … I'm fighting for time… that’s my reality. (UKPT05)

The variability and complexity of eligibility criteria was a major challenge for patients and determined the pathway and access to CTs:

I think all the trials have their own set of rules, so some of them will say, you need to have had this, this and this or you need not to have had this or this… your blood results need to be showing this, and you need to have had at least one of… They're all different sets of rules for gateways for getting in. (UKPT05)

Alongside the complexity of trial inclusion/exclusion criteria, patients wanted to know who was responsible for identifying individual patients for suitable CTs.

The thing about clinical trials that I'm still not clear on…I've spoken to quite a lot of patients and carers now, who’s on the lookout for clinical [trials]? Whose responsibility is it to be on the lookout for something that’s going to possibly be…you’re eligible for? (UKPT68)

Where consultants were engaged advocates with knowledge of CTs, patients reflected on feeling excited, energetic and enthusiastic for the future:

He said, I want to put you on this trial…and I was actually excited by it because he was so energetic and he was just like it’s all systems go. And I liked that, I liked the motivation and the feeling that he was giving me. But nobody else has spoken to me about it, just me asking about what is the best chance of quality of life?. (UKPT47)

In addition to the challenges of identifying a suitable CT, patients also reflected on the location of the trial site. One such example was a patient considering the capability of smaller vs larger trial sites, considering that ‘larger’ hospitals may have more experience and be more trustworthy.

Maybe I should be going to [hospital name] to get one of the big hospitals who are used to dealing with this [trial], rather than [hospital name], because would they actually have a neurologist near to hand for brain damage - are they coordinated? I've not seen any evidence that they are, and I would just be really worried. (UKPT48)

Discussion

Three themes emerged from the analysis: (1) Matching psychological support to specific moments , (2) Finding a voice in treatment decisions , and (3) Learning to navigate clinical trials . The results revealed the considerable challenges experienced by patients with TCRMM, the turbulent journey they had to overcome, and in some cases master over time. Some patients with TCRMM carried the ongoing physical and emotional burden of the disease, from diagnosis through each relapse and once refractory to treatment.

Some patients reflected on the way their diagnosis was conveyed to them by HCPs, the fact that their families no longer visited them because of misconceptions around the terminal nature of cancer, and the isolation that ensued from their diagnosis. Other patients mentioned the challenges of accessing potentially lifesaving CTs with novel treatments and new options that were unavailable in standard of care (SOC). Barriers to entry to CTs due to endless and confusing exclusion criteria alongside a lack of certainty over the individual(s) responsible for identifying potential CTs was insurmountable for some patients. Where SOC treatments had been exhausted, patients became increasingly positive about their future when CTs were identified and discussed in consultations. Healthcare professionals with knowledge of CTs were viewed as patient advocates which resulted in patients feeling increasingly positive about their future.

MM patients increasingly suffer from depression and anxiety associated with their disease, treatments, and risk of early mortality, all key unmet needs in the later stages of MM. 21 This was evident by the recurrent theme of the psychological burden of MM in most patient narratives and viewed as an essential part of patient care. Despite these views, patients reflected on the lack of emphasis on this crucial aspect of care, the need for greater medical education to foster improved discussions around psychological well-being in consultations, and a better understanding of the value of psychological input in MM. Patients reflected on the requirement for psychological intervention(s) at salient timepoints, including at diagnosis, during treatment and at relapse where considerable uncertainties were experienced. Side-effects were also a significant psychological burden for patients. Engaging in SDM in consultations supported self-management of side-effects, resulting in improved HRQoL, personal relationships and provided patients with the opportunity to maintain their self-identity.

TCRMM patients consistently referenced the need to engage in SDM in consultations and develop an alliance with their HCPs, as this positively impacted consultations, the treatment experiences and the overall HRQoL of patients. SDM was most likely to become normative in consultations once patients built up knowledge of the disease, personal wisdom of how they felt physically and emotionally, and understood the value of collaboration. SDM has become increasingly important to effective patient-centred care in MM and supports patients to navigate complex treatment pathways. 22 Research has shown SDM remains uncommon in MM care, with HCPs concerned this approach may overburden patients. 21 In this study, patients with TCRMM wanted to be active agents in treatment decisions and have their preferences and priorities recognised, reflecting patient preferences for a shared approach in clinical consultations. 23 These results also echo previous research emphasising that positive and trusting relationships with HCPs are central to patients’ feeling involved in their care 24 ; a key focus for the delivery of HCP education in haematology.

Taken together, more effective communication in consultations and embedding SDM into consultations should transform patients HRQoL. Effective clinical communication skills are the cornerstone of good clinical practice and support patients to discuss their priorities, preferences, and confirm patients understanding of their diagnosis, treatments and care. 25 While this is optimal, busy clinics and limited healthcare resources can make it challenging to achieve in clinical practice. While communication skills are developed during medical training, 26 the need for ongoing professional development of HCPs’ communication skills, and increased knowledge of the benefits of different types of psycho-oncology input are essential to improvements in care (i.e. Health Psychology, Clinical Psychology, Counselling etc.). Furthermore, a new set of guidance/training to support HCPs to implement holistic needs into MM care may optimise patient experiences and ensure appropriate services are provided to patients.

Clinical implications

An increased range of psychological services, the development of accessible practical tools to support psychological well-being and engagement in SDM in standard-of-care treatment and CTs would be beneficial to TCRMM patients. Patient-focused and comprehensive educational materials could empower patients to explore all treatment options. Likewise, more training and resources for HCPs in communication skills could improve clinical consultations and treatment planning.

Eliminating structural barriers to CTs and leveraging novel strategies for innovative trial designs in MM to increase access to new treatments is crucial. 27
28 There is also a need to have access to a one-stop platform on which CT information can be held, that is accessible to patients, caregivers, and HCPs.

Strengths and limitations of the study

This study takes a novel, in-depth examination of the journey through TCRMM from a patient perspective. Patients with MM may experience different treatment pathways due to frailty and their response to previous treatments. Once patients are diagnosed as TCR they experience similar levels of disease burden and have few remaining options. Thus, the psychological profiles and disease burden in TCR patients is likely to be similar, regardless of the number of treatments patients have received and speed at which they arrive at a TCR diagnosis. While inferences based on prevalence within the data have been made, a future quantitative study could support statistical generalisation of the challenges highlighted by patients with TCRMM in this study. The sample in this study was entirely white British and may not reflect the wider experiences of patients from ethnic minority groups. Future studies need to examine the experiences of patients from a more representative UK population sample of people living with MM, particularly in black populations where there is a higher prevalence of MM and experience greater health inequalities, including access to clinical trials. 29 Finally, our study focused on patient perspectives; HCPs were not a primary consideration in this work. However, examining the perspectives of HCPs may act to enhance the development and implementation of service improvements recommended in this paper for TCRMM patients in the future.

Lay patient summary

Non-expert readers can refer to the lay patient summary of this article which has been provided as supplementary material (see online supplemental material 5 ).

Study protocol

The original protocol for this study can be found within the online supplemental fil e.

Supplementary material

Acknowledgements

We would like to thank all the patients who took the time to participate in the interviews, Just Worldwide for supporting recruitment for the study, and the Digital Team in Myeloma UK (Caitlin Genoe, Holly Ashall and Emma Pellegrini) for raising awareness of the research. Customer Faithful would like to thank Dr. Jasmine Hearn and Dr. Ariele Noble for their help in supporting this study. Pfizer Ltd would like to thank Oliver Holland and Kyung-Min Lee for supporting the editorial review of this manuscript.

Footnotes

Funding: The study was conducted as a collaboration between Pfizer Ltd, Customer Faithful Ltd and Myeloma UK. Pfizer Ltd is the study sponsor. Customer Faithful Ltd (RH and Jasmine Hearn) acted as the vendor and received funding from Pfizer Ltd for the conduct of the study, synthesis of the results and medical writing of the manuscript. Myeloma UK (SQ) assisted with the conduct of the study and development of the manuscript, and received funding from Pfizer Ltd. Additional medical editing support was provided by OPEN Health (Jasmine Malone).

Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online ( https://doi.org/10.1136/bmjopen-2025-108269 ).

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient consent for publication: Not applicable.

Ethics approval: This study involves human participants and was approved by Cambridge East Research Ethics Committee, United Kingdom (IRAS Ref No. 313372). Participants gave informed consent to participate in the study before taking part.

Patient and public involvement: Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

Presented at: An e-poster of this study was presented at the British Journal of Haematology 64th Annual Scientific Meeting in Liverpool, April 2024. e-Posters, British Journal of Haematology Vol 204, https://doi.org/10.1111/bjh.19399 .

Data availability statement

Data are available upon reasonable request.

References