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Background Immunotherapy has resulted in unprecedented improvements in survival and maintained quality of life for many patients with advanced melanoma. However, durable responses are observed in only a minority of patients, and severe treatment side effects are experienced by 5%–30%. There are no reliable tests that can differentiate between patients who are likely to respond to immunotherapy and those who will not. Hence, new challenges have arisen as clinicians try to facilitate patients in their decision-making regarding immunotherapy. Furthermore, little is known about the real-world patients’ experience and understanding of immunotherapy outside the clinical trial setting. Here, we explore the perspectives of patients undergoing immunotherapy for melanoma and focus on factors that influenced their treatment decision-making. Materials and Methods Twenty-three in-depth semistructured interviews were conducted with patients receiving pembrolizumab for stage IV melanoma at an Australian public cancer hospital. Patients were recruited at a range of time points after commencing therapy, and their experience of treatment was explored. Interviews were audio recorded, transcribed verbatim, coded, and analyzed thematically. Results Immunotherapy is viewed as a symbol of hope, with high-profile anecdotes reinforcing this perception. Only a minority of patients expressed a good understanding of the likely efficacy and potential treatment side effects. Patients are reliant on their clinicians’ recommendation regarding immunotherapy treatment decisions. Conclusion Novel treatments such as immunotherapy provide significant hope for patients. This may influence their preference for immunotherapy over and above the usual considerations of the trade-off between efficacy and toxicity. Careful counsel and individualized patient resources may further facilitate treatment decision-making. Implications for Practice This study highlighted some of the misconceptions held by patients that need to be addressed when discussing the possibility of receiving treatment with immunotherapy for advanced melanoma. Patients placed a lot of importance on high-profile anecdotes rather than truly understanding likely outcomes of treatment based on personal circumstances. The majority of patients had a poor understanding of the potential side effects and long-term implications of treatment with immunotherapy. Careful counsel is required in order to facilitate informed decision-making about treatment and to ensure possible side effects are known and appreciated. Further research is needed to develop tools to aid decision-making in everyday clinical practice.

IntroductionThere is increasing evidence demonstrating the benefits of exercise in counteracting cancer treatment-related fatigue. Immunotherapy is an established treatment for advanced melanoma, and is associated with fatigue in a third of patients. The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined. This study aims to assess the safety, adherence to and acceptability of a mixed-methods parallel-group, pilot randomised controlled trial of a personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove) in 30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent ipilimumab, nivolumab or pembrolizumab, or combination ipilimumab and nivolumab. The trial will be used to provide preliminary evidence of the potential efficacy of exercise for managing fatigue.Methods and analysisThirty participants will be recruited from a specialist cancer centre between May and September, 2019. Participants will be randomised 1:1 to receive iMove, or usual care (an information booklet about exercise for people with cancer). Feasibility data comprise: eligibility; recruitment and retention rates; adherence to and acceptability of exercise consultations, personalised exercise programme and study measures; and exercise-related adverse events. Patient-reported outcome measures assess potential impact of the exercise intervention on: fatigue, role functioning, symptoms and quality of life. Follow-up will comprise five time points over 24 weeks. Physical assessments measure physical fitness and functioning.Ethics and disseminationThis study was reviewed and approved by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/48927/PMCC-2019). The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with clinicians, media, government and consumers. In particular, we will promote the outcomes of this work among the oncology community should this pilot indicate benefit for patients.Trial registration numberACTRN12619000952145; Pre-results.

Background: Immunotherapy has dramatically changed the treatment landscape and survival outcomes for patients with advanced melanoma. However, the success rates for immunotherapy are varied, and unpredictable. Immunotherapy can result in a range of treatment related toxicities, many of which can impact significantly on quality of life (QoL); or become life-threatening. Immunotherapies are administered in an ambulatory setting and as such, much of the responsibility for side-effect recognition, reporting, and monitoring falls to patients and their informal caregivers. Given the importance of early side-effect identification and management, it is important to understand the patient and caregiver experience of immunotherapy to facilitate patient safety. Aim: To: Explore the experiences of patients with advanced melanoma who received immunotherapy, and their informal caregivers Investigate the impact of immunotherapy treatment (in particular toxicities) on QoL of patients and their caregivers Identify behaviors and strategies patients and caregivers' used to manage immunotherapy treatment and toxicities. Methods: This cross-sectional, exploratory study used qualitative interviews with patients with stage IV melanoma who had completed, or were receiving nivolumab, pembrolizumab or ipilimumab as monotherapy, and their caregivers. Analysis used interpretive description methodology. Results: Twenty three patients and nine caregivers took part. Patients and caregivers discussed feelings of uncertainty regarding immunotherapy efficacy and toxicities; and raised concerns about correctly identifying relevant and reportable symptoms. Some participants did not see the link between symptoms experienced and treatment despite being satisfied with the level of information provided by their healthcare team. This highlights a potential lack of understanding about side-effects and/or deficiencies in the way treatment education is delivered. This was particularly concerning when resulting in delayed nursing or medical intervention. Findings identified the integral role caregivers have in the care of patients receiving immunotherapy. Conclusion: Despite immunotherapy improving survival rates for many patients with melanoma their QoL, and that of their caregivers can be negatively impacted by uncertainty about efficacy and the identification and reporting of potential side effects. Patient and caregiver experience may be improved with better education about what to expect, provided in various formats and at multiple time points, in conjunction with defined pathways for rapid access to the nursing and medical advice.