Cancer patients’ experiences with immune checkpoint modulators: A qualitative study

Ala‐Leppilampi, Kari; Baker, Nick; McKillop, Chris; Butler, Marcus O.; Siu, Lillian L.; Spreafico, Anna; Razak, Albiruni R. Abdul; Joshua, Anthony M.; Hogg, David; Bedard, Philippe L.; Leighl, Natasha B.; Oza, Amit M.; Parsons, Janet; Hansen, Aaron R.

doi:10.1002/cam4.2940

Cited by 25 publications

(53 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Despite thematic saturation being achieved we accept that our sample size was limited; however, our study complements findings from similar studies in this area, as well as broader toxicity management evaluations, which justifies the transferability of our findings. In fact, a recently published study [19] examined patients' experiences with immune checkpoint modulators, recruited from one organisation in Toronto, Canada, with a focus on their side effects and how these impacted on their daily life. They identified eight themes, characterising the complexity of these patients' lived experiences: major categories of side effects experienced and how they impacted patient well-being; the heterogeneous nature of side effects experienced, all of which were reflected in our category of 'variability'; living with uncertainty; reframing the meaning and severity of SEs; focus on survival, hope, and being positive; acceptance and adaptation; feeling supported; and faith in medical innovation, which correspond to our psychological impact categories.…”

Section: Strengths and Limitationsmentioning

confidence: 99%

Immunotherapy and associated immune-related adverse events at a large UK centre: a mixed methods study

Jamieson¹,

Förster

Zaki

et al. 2020

BMC Cancer

View full text Add to dashboard Cite

Background: The development and rapid uptake of immune checkpoint inhibitors (CPI) has changed the outlook for patients with cancer. However, CPIs have different adverse event (AE) profiles to other systemic therapies, and prompt AE management is essential to assure optimal outcomes. In order to understand what and when adverse events are experienced, reported and managed during CPI treatment, a mixed methods study was conducted, including a case note review of patients who were receiving immunotherapy and semi-structured interviews with patients to understand their experience, management and reporting of AEs after receiving immune CPI treatment. Methods: This mixed methods study was conducted at a large cancer hospital in the United Kingdom. A case note review identified how and where patients reported AEs. Data relating to patients with lung, bladder, prostate and head & neck cancers who received CPI treatment between 01/04/2015 and 31/07/2018 were extracted from eprescribing databases and clinical data were included for analysis at a single time point (31 July 2018). Semistructured interviews were conducted with patients receiving CPI treatment, exploring experience of AEs and reasons for delays in AE reporting and management. Results: Sixty-two patients were included in the case note review, with 78 AEs being experienced by 36 patients (58%), including one patient experiencing 10 AEs. Serious AEs were experienced by 12 patients (19%) and ten AEs (17%) required oral steroids as treatment. The majority of AEs were reported to clinicians prior to further dosing, although milder AEs were often not addressed until subsequent clinic appointments. Interviews with 13 patients yielded major themes: variability, causality, decision making and impact. Conclusion: Most CPI-associated AEs are manageable if reported and treated promptly. Both the case note review and interviews found that reporting of non-serious AEs is often left until routine clinic visits, despite impacting patient experience, leaving the opportunity for AEs to be left unreported and implying a potential benefit for real time monitoring. Our study highlights a need to provide patients with reminders around AEs and their timely reporting even when apparently innocuous; patients must understand that AEs can occur at any cycle and even following treatment completion.

show abstract

Section: Strengths and Limitationsmentioning

confidence: 99%

Immunotherapy and associated immune-related adverse events at a large UK centre: a mixed methods study

Jamieson¹,

Förster

Zaki

et al. 2020

BMC Cancer

View full text Add to dashboard Cite

show abstract

“…The qualitative methodology used for eliciting the lived experiences of patients treated with ICMs has been reported elsewhere . Herein, we have described the specific methodology for the development of the toxicity subscale.…”

Section: Methodsmentioning

confidence: 99%

“…Although our approach to conducting patient enrollment, focus groups, and interviews has been described in detail elsewhere, we will reiterate a few pertinent details here. Patient participants were recruited from a large tertiary care cancer treatment center in Toronto, Ontario, Canada.…”

Section: Methodsmentioning

confidence: 99%

“…HRQOL for patients with cancer who are undergoing treatment is well recognized as a balance between efficacy and toxicity . Qualitative research we conducted on the experiences of patients treated with ICMs demonstrated that their irAEs had a significant impact on many aspects of their lives . We used the Functional Assessment of Cancer Illness Therapy (FACIT) measurement system to develop a toxicity subscale for patients treated with ICMs.…”

Section: Introductionmentioning

confidence: 99%

“…Patient input is essential to the development of such PRO measures because they must reflect patient experiences and language, which can be captured only through rigorous qualitative methods . Although an in‐depth qualitative analysis of the complex lived experiences of patients treated with ICMs is the focus of a related article, the current study deals specifically with the initial phases of scale development and our early efforts at content validation.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Development of the Functional Assessment of Cancer Therapy–Immune Checkpoint Modulator (FACT‐ICM): A toxicity subscale to measure quality of life in patients with cancer who are treated with ICMs

Hansen

Ala‐Leppilampi

McKillop³

et al. 2020

Cancer

Self Cite

View full text Add to dashboard Cite

Background Patients with cancer who are treated with immune checkpoint modulators (ICMs) have their health‐related quality of life (HRQOL) measured using general patient‐reported outcome (PRO) tools. To the authors' knowledge, no instrument has been developed to date specifically for patients treated with ICMs. The objective of the current study was to develop a toxicity subscale PRO instrument for patients treated with ICMs to assess HRQOL. Methods Input was collected from a systematic review as well as patients and physicians experienced with ICM treatment. Descriptive thematic analysis was used to evaluate the qualitative data obtained from patient focus groups and interviews, which informed an initial list of items that described ICM side effects and their impact on HRQOL. These inputs informed item generation and/or reduction to develop a toxicity subscale. Results Focus groups and individual interviews with 37 ICM‐treated patients generated an initial list of 176 items. After a first round of item reduction that produced a shortened list of 76 items, 16 physicians who care for patients who are treated with ICMs were surveyed with a list of 49 patient‐reported side effects and 11 physicians participated in follow‐up interviews. A second round of item reduction was informed by the physician responses to produce a list of 25 items. Conclusions To the authors' knowledge, this 25‐item list is the first HRQOL‐focused toxicity subscale for patients treated with ICMs and was developed in accordance with US Food and Drug Administration guidelines, which prioritize patient input in developing PRO tools. The subscale will be combined with the Functional Assessment of Cancer Therapy–General (FACT‐G) to form the FACT‐ICM. Prior to recommending the formal use of this PRO instrument, the authors will evaluate its validity and reliability in longitudinal studies involving substantially more patients.

show abstract

Health‐related quality‐of‐life assessment of patients with solid tumors on immuno‐oncology therapies

Voon

Cella

Hansen

2021

Cancer

Self Cite

View full text Add to dashboard Cite

Immuno‐oncology therapies have been approved for various solid tumors; however, the high cost of these treatments and their potential toxicities require a thorough assessment of their risks and benefits. Collection of data directly from patients through patient‐reported outcome instruments can improve the precision and reliability of adverse event detection, assess tolerability of adverse events, and provide an evaluation of health‐related quality of life (HRQOL) changes from immuno‐oncology therapies. There is robust development in HRQOL tools specifically for patients treated with immuno‐oncology agents. This review examines the history and basic concepts of HRQOL and patient‐reported outcome assessments commonly used in oncological trials, highlighting the strengths and weaknesses of current approaches when applied to immunotherapies, as well as some of the current efforts to develop tools for this field and opportunities for future research. Lay Summary Immuno‐oncology (IO) therapies are costly and carry potential toxicities known as immune‐related adverse events. Evaluation of health‐related quality of life (HRQOL) can impact the risk‐benefit assessment of IO therapies. Integration of HRQOL end points and patient‐reported outcome data for IO therapies are urgently needed. Ongoing robust development of patient‐reported outcome tools specific to IO therapies are currently underway and will permit the evaluation of HRQOL for IO agents. Improvement in precision and reliability of HRQOL evaluation will enhance the ultimate true value of these expensive and effective drugs.

show abstract

Cancer patients’ experiences with immune checkpoint modulators: A qualitative study

Cited by 25 publications

References 31 publications

Immunotherapy and associated immune-related adverse events at a large UK centre: a mixed methods study

Immunotherapy and associated immune-related adverse events at a large UK centre: a mixed methods study

Development of the Functional Assessment of Cancer Therapy–Immune Checkpoint Modulator (FACT‐ICM): A toxicity subscale to measure quality of life in patients with cancer who are treated with ICMs

Health‐related quality‐of‐life assessment of patients with solid tumors on immuno‐oncology therapies

Contact Info

Product

Resources

About