Clinical Utility Assessment of a Nursing Checklist Identifying Complex Care Needs Due to Inequities Among Ambulatory Patients With Cancer: Protocol for a Mixed Methods Study.

BACKGROUND: Disparities in cancer incidence, complex care needs, and poor health outcomes are largely driven by structural inequities stemming from social determinants of health. To date, no evidence-based clinical tool has been developed to identify newly diagnosed patients at risk of poorer outcomes. Specialist cancer nurses are well-positioned to ameliorate inequity of opportunity for optimal care, treatment, and outcomes through timely screening, assessment, and intervention. We designed a nursing complexity checklist (the "Checklist") to support these activities, with the ultimate goal of improving equitable experiences and outcomes of care. This study aims to generate evidence regarding the clinical utility of the Checklist. OBJECTIVE: The primary objectives of this study are to provide qualitative evidence regarding key aspects of the Checklist's clinical utility (appropriateness, acceptability, and practicability), informed by Smart's multidimensional model of clinical utility. Secondary objectives explore the predictive value of the Checklist and concordance between specific checklist items and patient-reported outcome measures. METHODS: This prospective mixed methods case series study will recruit up to 60 newly diagnosed patients with cancer and 10 specialist nurses from a specialist cancer center. Nurses will complete the Checklist with patient participants. Within 2 weeks of Checklist completion, patients will complete 5 patient-reported outcome measures with established psychometric properties that correspond to specific checklist items and an individual semistructured interview to explore Checklist clinical utility. Interviews with nurses will occur 12 and 24 weeks after they first complete a checklist, exploring perceptions of the Checklist's clinical utility including barriers and facilitators to implementation. Data describing planned and unplanned patient service use will be collected from patient follow-up interviews at 12 weeks and the electronic medical record at 24 weeks after Checklist completion. Descriptive statistics will summarize operational, checklist, and electronic medical record data. The predictive value of the Checklist and the relationship between specific checklist items and relevant patient-reported outcome measures will be examined using descriptive statistics, contingency tables, measures of association, and plots as appropriate. Qualitative data will be analyzed using a content analysis approach. RESULTS: This study was approved by the institution's ethics committee. The enrollment period commenced in May 2022 and ended in November 2022. In total, 37 patients with cancer and 7 specialist cancer nurses were recruited at this time. Data collection is scheduled for completion at the end of May 2023. CONCLUSIONS: This study will evaluate key clinical utility dimensions of a nursing complexity checklist. It will also provide preliminary evidence on its predictive value and information to support its seamless implementation into everyday practice including, but not limited to, possible revisions to the Checklist, instructions, and training for relevant personnel. Future implementation of this Checklist may improve equity of opportunity of access to care for patients with cancer. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48432.

Feasibility and preliminary effectiveness of virtual reality as a patient education tool for people with cancer undergoing immunotherapy: a protocol for a randomised controlled pilot study in a regional setting.

INTRODUCTION: Patient education is a critical component of healthcare delivery. However, medical information and knowledge are complex and can be difficult for patients and families to comprehend when delivered verbally. The use of virtual reality (VR) to convey medical information to patients may bridge this communication gap and lead to more effective patient education. It may be of increased value to those with low health literacy and levels of patient activation, in rural and regional settings. The objective of this randomised, single-centre pilot study is to examine the feasibility and preliminary effectiveness of VR as an education tool for people with cancer. The results will provide data to inform the feasibility of a future randomised controlled trial, including sample size calculations. METHODS AND ANALYSIS: Patients with cancer undergoing immunotherapy will be recruited. A total of 36 patients will be recruited and randomised to one of three trial arms. Participants will be randomised 1:1:1 to receive VR, a two-dimensional video or standard care (ie, verbal communication and information leaflets). Feasibility will be assessed by recruitment rate, practicality, acceptability, usability and related adverse events. The potential impact of VR on patient-reported outcomes (ie, perceived information provision quality, knowledge about immunotherapy and patient activation) will be assessed and stratified by information coping style (ie, monitors vs blunters) whenever statistical analyses are significant. The patient-reported outcomes will be measured at baseline, post-intervention and 2 weeks post-intervention. In addition, semistructured interviews will be conducted with health professionals and participants randomised to the VR trial arm, to further explore acceptability and feasibility. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Greater Western Human Research Ethics Committee, New South Wales Local Health District (2022/ETH01760). Informed consent will be obtained from all participants. Findings will be disseminated via relevant conference presentations and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12622001473752.

Protocol for the implementation of a stepped-care model to address fear of cancer recurrence in patients previously diagnosed with early-stage (0-II) melanoma.

INTRODUCTION: Fear of cancer recurrence (FCR) is commonly reported by patients diagnosed with early-stage (0-II) melanoma and can have a significant impact on daily functioning. This study will pilot the implementation of the Melanoma Care Program, an evidence-based, psychological intervention to reduce FCR, into routine practice, using a stepped-care model. METHODS AND ANALYSIS: Intervention effectiveness and level of implementation will be investigated using a hybrid type I design. Between 4 weeks before and 1 week after their next dermatological appointment, patients with melanoma will be invited to complete the Fear of Cancer Recurrence Inventory Short-Form, measuring self-reported FCR severity. Using a stepped-care model, clinical cut-off points will guide the level of support offered to patients. This includes: (1) usual care, (2) Melanoma: Questions and Answers psychoeducational booklet, and (3) three or five psychotherapeutic telehealth sessions. This longitudinal, mixed-methods pilot implementation study aims to recruit 108 patients previously diagnosed with stage 0-II melanoma. The primary effectiveness outcome is change in FCR severity over time. Secondary effectiveness outcomes include change in anxiety, depression, stress, health-related quality of life and melanoma-related knowledge over time. All outcomes are measured at baseline, within 1 week of the final telehealth session, and 6 and 12 months post-intervention. Implementation stakeholders at each study site and interested patients will provide feedback on intervention acceptability and appropriateness. Implementation stakeholders will also provide feedback on intervention cost, feasibility, fidelity and sustainability. These outcomes will be measured throughout implementation, using questionnaires and semistructured interviews/expert group discussions. Descriptive statistics, linear mixed-effects regression and thematic analysis will be used to analyse study data. ETHICS AND DISSEMINATION: Ethics approval was granted by the Sydney Local Health District-Royal Prince Alfred Zone (2020/ETH02518), protocol number: X20-0495. Results will be disseminated through peer-reviewed journals, conference presentations, social media and result summaries distributed to interested participants. TRIAL REGISTRATION DETAILS: (ACTRN12621000145808).

Embedding electronic patient-reported outcome measures into routine care for patients with stage III MELanoma (ePROMs-MEL): protocol for a prospective, longitudinal, mixed-methods pilot study.

INTRODUCTION: The benefits of patient-reported feedback, using questionnaires that allow patients to report how they feel and function without any interpretation from healthcare professionals, are well established. However, patient-reported outcomes measures (PROMs) are not routinely collected in patients with melanoma in Australia. The aim of this study is to evaluate the feasibility and acceptability of implementing electronic PROMs (ePROMs) into routine care from the perspectives of patients with stage III melanoma and their treating clinical team. METHODS AND ANALYSIS: A minimum of 50 patients and 5 clinicians will be recruited to this prospective, longitudinal pilot study (ePROMs-MELanoma). The study uses a mixed-methods approach (quantitative PROMs questionnaires and end-of-study surveys with qualitative interviews) and commenced in May 2021 in surgical and medical melanoma clinics at two sites in metropolitan Sydney, Australia. The primary outcomes are measures of feasibility and acceptability, comprising descriptive questionnaire completion statistics, and proportion of patients who reported that these PROMs were easy to complete and measured items they considered important. Clinician and clinic staff views will be canvassed on the appropriateness of these PROMs for their patients, change in referral practice and uptake and incorporation into routine practice. Secondary aims include measurement of improvements in patients' emotional and physical health and well-being, and utility of real-time data capture and clinician feedback. All participants will complete the Distress Thermometer and EQ-5D-5L questionnaires in the clinic using a tablet computer at baseline and two to three subsequent follow-up appointments. Participants who report a score of 4 or higher on the Distress Thermometer will be triaged to complete an additional three questionnaires: the QLQ-C30, Depression, Anxiety and Stress Scale and Melanoma Concerns Questionnaire-28. Results will be generated in real time; patients with psychosocial distress or poor quality of life will discuss possible referral to appropriate allied health services with their clinician. Thematic analysis of interviews will be conducted. ETHICS AND DISSEMINATION: Ethics approval obtained from St Vincent's Hospital Human Research Ethics Committee on 19 September 2019 (2019/ETH10558), with amendments approved on 8 June 2022. Patient consent is obtained electronically prior to questionnaire commencement. Dissemination strategies will include publication in peer-reviewed journals and presentation at international conferences, tailored presentations for clinical societies and government bodies, organisational reporting through multidisciplinary meetings and research symposia for local clinicians and clinic staff, and more informal, lay reports and presentations for consumer melanoma representative bodies and patient participants and their families. TRIAL REGISTRATION NUMBER: ACTRN12620001149954.

Moderators of intervention efficacy for Finding My Way: A web-based psychosocial intervention for cancer-related distress.

PURPOSE: The present analysis explores whether demographic, psychosocial, or intervention adherence factors moderated treatment efficacy of Finding My Way (FMW), an efficacious self-directed web-based psychosocial program for newly diagnosed curatively treated cancer patients. METHODS: Participants (n = 191) completed a 6-module intervention (n = 94) or attention-control (n = 97) program. Outcome measures were completed at baseline (T0), post-program (T1), 3-month (T2), and 6-month (T3) follow ups. Age, gender, social support, information processing style (monitoring vs blunting), emotion-regulation difficulties, and intervention adherence were examined as potential moderators. RESULTS: Age moderated emotional functioning and general distress at T3 with significant intervention benefits only observed in younger participants; age moderated cognitive functioning at T1, with intervention benefits only found in older participants. Gender moderated helplessness/hopelessness, emotional functioning, and cognitive avoidance at T1 with men benefitting more from receiving the intervention vs control. Monitoring information-processing style moderated cancer distress and anxious preoccupation at T3: higher monitors benefitted more from receiving the intervention vs control. Program adherence moderated global QOL, emotional functioning and social functioning at T2 and T3; cognitive avoidance (T1), anxious preoccupation (T2) and role function (T3), with those who completed more of the program benefitting more if they received the intervention than control. Emotion dysregulation and social support each moderated role function at T2, with those more dysregulated and less socially supported benefitting more if they received the intervention than control. CONCLUSIONS: For select outcomes, FMW is more effective for patients with specific characteristics; these findings can inform future tailoring and targeting of online programs for cancer-distress.

Identification of low health and cancer literacy in oncology patients: a cross-sectional survey.

OBJECTIVE: Health literacy is a significant public health concern, particularly given the increased complexity of chronic disease health management and health system navigation, and documented associations between low health literacy and poor health outcomes. This study therefore aimed to identify the proportion and characteristics of outpatients visiting a specialist cancer hospital who report low health literacy and/or low cancer health literacy. METHOD: This study used a cross-sectional survey administered verbally with patients attending a specialist cancer hospital located in Melbourne, Australia over a two-week period. Process data on conducting health literacy screening within a clinical setting was collected. RESULTS: Those identified with inadequate general health literacy were different to those identified with low cancer-specific health literacy, although overall both proportions were low. Cross-sectional screening of patients was difficult, despite utilising verbal surveying methods designed to increase capacity for participation. CONCLUSION: Health literacy screening using the tools selected was not useful for identifying or describing patients with low health literacy in this setting, given the disparity in those categorised by each measure. PRACTICE IMPLICATIONS: Until the theoretical construct of health literacy is better defined, measurement of health literacy may not be clinically useful.

Should I Have Adjuvant Immunotherapy? An Interview Study Among Adults with Resected Stage 3 Melanoma and Their Partners.

BACKGROUND: Adjuvant immunotherapy is a new treatment paradigm for adults with resected stage 3 melanoma. However, therapy can lead to long-term adverse health impacts, making immunotherapy decisions difficult. This study aimed to explore patients and their partners' views when considering whether to commence adjuvant immunotherapy. METHODS: Focus groups and in-depth interviews were conducted among adults with resected stage 3 melanoma and their partners between August 2019 and April 2020. Factors important to adjuvant immunotherapy decision making were explored. Recruitment continued until data saturation, with thematic analysis performed. RESULTS: Thirty-six participants were recruited across two cohorts, including 24 patients (mean age 65 years, 71% male), and 12 partners (mean age 69 years, 75% female). Twenty-two patients (92%) received adjuvant immunotherapy, two (8%) declined. Five patients (21%) ceased treatment early because of toxicity. Five themes about adjuvant immunotherapy were common to all participants: (1) life and death; (2) perceived risks and benefits; (3) seeking information; (4) healthcare team relationship; and (5) immunotherapy treatment considerations. Prolonging life was the primary consideration, with secondary concerns about treatment burden, timing, costs and efficacy. CONCLUSIONS: This information can be used by clinicians to support melanoma treatment decision making.

Melanoma is a type of skin cancer that can be deadly. Treatment for melanoma involves surgery to remove it and can be followed by extra (adjuvant) immunotherapy, a type of drug that uses the body's immune system to fight any leftover melanoma. Immunotherapy can help a person live longer but has downsides or side effects that may need a person to take daily medication for life. We spoke to patients with melanoma and their partners to learn what was important to them when deciding to have immunotherapy. Living longer was most important, followed by concerns about treatment difficulties and costs. This information will help doctors and nurses discuss treatment options for melanoma with patients and their families.

Defining Expertise in Cancer Nursing Practice.

BACKGROUND: Thirty-five years ago, Benner defined an expert nurse as one who applies deep knowledge and experience across different contexts and clinical situations. Since that time, there has been little exploration of expertise in cancer nursing. OBJECTIVES: To explore and describe characteristics of expert cancer nurses and to consider whether Benner's typology of an expert nurse remains relevant in today's complex oncology settings. METHODS: An exploratory, descriptive study using audio-recorded focus group methodology was undertaken. Audio-recordings were transcribed, and an inductive thematic analysis approach applied to the data. Nurses also documented key characteristics of expert practice on Post-it notes to illustrate dominant characteristics. RESULTS: Twenty-four registered nurses from a comprehensive cancer center in Australia took part in 1 of 3 focus groups. Seven key themes were identified: knowledge, leadership, adaptability, communication, motivation, patient-centered care, organization, and culture. Key word cloud characteristics included knowledge, compassion, motivation, experience, and communication. CONCLUSIONS: Many of the expert characteristics identified in this study reflect traits common to other nursing specialty groups. Of particular relevance to cancer nurses was "adaptability," reflecting the complexity of contemporary cancer care and reaffirming Benner's definition of an expert nurse as one who can fluidly connect knowledge and experience to unfamiliar practice contexts. IMPLICATIONS FOR PRACTICE: Understanding characteristics of expert cancer nurses may help inform and support professional practice advancement and guide future research about select characteristics of expert cancer nurses to patient- and system-level outcomes.

Co-design and development of online video resources about immunotherapy with patients and their family.

BACKGROUND: Patients receiving novel treatments like immune checkpoint inhibitor therapy (ICI or immunotherapy) to treat their cancer require comprehensive information so they know what to expect and to encourage the identification and reporting of possible side-effects. Videos using patient stories can be reassuring and an effective method for conveying health information. OBJECTIVE: The objective of this study was to use a co-design process to develop video resources about immunotherapy to identify a) the key informational and supportive care needs of patients and family carers and b) topics clinicians recommended be addressed during pre-treatment nurse-led education. PATIENT INVOLVEMENT: Experience Based Co-design (EBCD) provided the framework for video development, to facilitate patient and carer involvement in every stage of research design and implementation, and video design and development. METHODS: Data were collected and used in four stages: 1) qualitative interviews, 2) co-design workshop, 3) filming plan and 4) feedback and editing. RESULTS: Thirty-five individuals contributed to the development of a suite of five videos called "Immunotherapy: What to Expect". Videos covered general treatment information, preparation for infusion, potential side-effects, balancing lifestyle with treatment and seeking support. Video run time ranges from 6 to 15 min. DISCUSSION: The EBCD process ensured that videos were developed to meet patient and carer identified needs associated with commencing and managing ICI therapy. The structure of EBCD in facilitating patient and carer involvement throughout the research and video development process ensured transparency throughout the project, and continuity of message, scope and outcomes. PRACTICAL VALUE: EBCD is a useful framework for developing patient-centred health resources. The videos developed are now available for patients and carers via YouTube, and provide education and support tailored to this groups' needs regarding ICI therapy for cancer.

Feasibility and Acceptability of Fear-Less: A Stepped-Care Program to Manage Fear of Cancer Recurrence in People with Metastatic Melanoma.

Immunotherapies and targeted therapies have revolutionised treatment of metastatic melanoma and improved survival rates. However, survivors treated with novel therapies are vulnerable to high levels of fear of cancer recurrence or progression (FCR). Existing FCR interventions have rarely been trialled in people with advanced cancer. The current study aimed to evaluate the acceptability and feasibility of Fear-Less: a stepped-care model to treat FCR in people with metastatic melanoma treated with immunotherapy or targeted therapy. Sixty-one outpatients with metastatic melanoma were screened using the Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) and Fear of Progression Questionnaire Short Form (FoP-Q-SF). Survivors with subthreshold FCR were stratified to a self-management intervention while those with clinical levels of FCR were provided with an individual therapy, Conquer Fear. Survivor experience surveys and rescreening were administered post-intervention completion. Results indicated that Fear-Less was an acceptable and feasible FCR intervention. Results provided preliminary support for the potential impact of Fear-Less in reducing FCR. Fear-Less is a promising first step in providing an acceptable and feasible stepped-care model to treat FCR in survivors with metastatic disease.

18F-FDG PET/CT based spleen to liver ratio associates with clinical outcome to ipilimumab in patients with metastatic melanoma.

BACKGROUND: Immune checkpoint blockade such as ipilimumab and anti-PD1 monoclonal antibodies have significantly improved survival in advanced melanoma. Biomarkers are urgently needed as a majority of patients do not respond, despite treatment-related toxicities. We analysed pre-treatment 18F-fluorodeoxyglucose positron emission tomography/computerised tomography (FDG PET/CT) parameters to assess its correlation with patient outcome. METHODS: This retrospective study evaluated pre-treatment FDG PET/CT scans in a discovery cohort of patients with advanced melanoma treated with ipilimumab or anti-PD1. Pre-treatment scans were assessed for maximum tumoral standardised uptake value (SUVmax), metabolic tumour volume (MTV) and spleen to liver ratio (SLR). Progression-free survival (PFS) and overall survival (OS) were characterised and modelled using univariable and multivariable analyses. Correlation of SLR and OS was validated in an independent cohort. Blood parameters and stored sera of patients from the discovery cohort was analysed to investigate biological correlates with SLR. RESULTS: Of the 90 evaluable patients in the discovery cohort: 50 received ipilimumab monotherapy, 20 received anti-PD1 monotherapy, and 20 patients received ipilimumab followed by anti-PD1 upon disease progression. High SLR > 1.1 was associated with poor PFS (median 1 vs 3 months; HR 3.14, p = 0.008) for patients treated with ipilimumab. High SLR was associated with poor OS after ipilimumab (median 1 vs 21 months; HR 5.83, p = 0.0001); as well as poor OS after first line immunotherapy of either ipilimumab or anti-PD1 (median 1 vs 14 months; HR 3.92, p = 0.003). The association of high SLR and poor OS after ipilimumab was validated in an independent cohort of 110 patients (median 2.3 months versus 11.9 months, HR 3.74). SLR was associated with poor OS in a multi-variable model independent of stage, LDH, absolute lymphocyte count and MTV. CONCLUSIONS: Pre-treatment Spleen to liver ratio (SLR) > 1.1 was associated with poor outcome after ipilimumab in advanced melanoma. This parameter warrants prospective evaluation.

i-Move, a personalised exercise intervention for patients with advanced melanoma receiving immunotherapy: a randomised feasibility trial protocol.

INTRODUCTION: There 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 ANALYSIS: Thirty 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 DISSEMINATION: This 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 NUMBER: ACTRN12619000952145; Pre-results.

Testing Consultation Recordings in a Clinical Setting With the SecondEars Smartphone App: Mixed Methods Implementation Study.

BACKGROUND: Health care systems are increasingly looking to mobile device technologies (mobile health) to improve patient experience and health outcomes. SecondEars is a smartphone app designed to allow patients to audio-record medical consultations to improve recall, understanding, and health care self-management. Novel health interventions such as SecondEars often fail to be implemented post pilot-testing owing to inadequate user experience (UX) assessment, a key component of a comprehensive implementation strategy. OBJECTIVE: This study aimed to pilot the SecondEars app within an active clinical setting to identify factors necessary for optimal implementation. Objectives were to (1) investigate patient UX and acceptability, utility, and satisfaction with the SecondEars app, and (2) understand health professional perspectives on issues, solutions, and strategies for effective implementation of SecondEars. METHODS: A mixed methods implementation study was employed. Patients were invited to test the app to record consultations with participating oncology health professionals. Follow-up interviews were conducted with all participating patients (or carers) and health professionals, regarding uptake and extent of app use. Responses to the Mobile App Rating Scale (MARS) were also collected. Interviews were analyzed using interpretive descriptive methodology; all quantitative data were analyzed descriptively. RESULTS: A total of 24 patients used SecondEars to record consultations with 10 multidisciplinary health professionals. In all, 22 of these patients used SecondEars to listen to all or part of the recording, either alone or with family. All 100% of patient participants reported in the MARS that they would use SecondEars again and recommend it to others. A total of 3 themes were identified from the patient interviews relating to the UX of SecondEars: empowerment, facilitating support in cancer care, and usability. Further, 5 themes were identified from the health professional interviews relating to implementation of SecondEars: changing hospital culture, mitigating medico-legal concerns, improving patient care, communication, and practical implementation solutions. CONCLUSIONS: Data collected during pilot testing regarding recording use, UX, and health professional and patient perspectives will be important for designing an effective implementation strategy for SecondEars. Those testing the app found it useful and felt that it could facilitate the benefits of consultation recordings, along with providing patient empowerment and support. Potential issues regarding implementation were discussed, and solutions were generated. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12618000730202; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373915&isClinicalTrial=False.

Exploring the Experiences of People Treated With Immunotherapies for Advanced Melanoma and Those Caring for Them: "Real-World" Data.

BACKGROUND: Recent advances in the development of immunotherapy drugs have resulted in durable responses and improved overall survival for a proportion of patients with advanced melanoma; however, toxicities can be potentially life-threatening. The patients' family and friends (carers) are relied upon to support patients at home post treatment; however, we know little about their experiences. OBJECTIVES: This study aimed to understand the experiences of patients with advanced melanoma who received immunotherapy and their carers; and to explore the impact of immunotherapy treatment on patients' and carers' quality of life (QoL). METHODS: A cross-sectional, exploratory design was employed. Semi-structured interviews were conducted with patients: diagnosed with stage IV melanoma, attending an Australian public cancer hospital, had completed or were receiving treatment with immunotherapies; and the people caring for them at home. RESULTS: Patients (n = 22) described how immunotherapy impacted emotional health, functional ability; and had damaging economic consequences. Fatigue was reported consistently as having a considerable negative influence across all domains of QoL. Carers (n = 9) were anxious about their ability to correctly identify, report and manage side effects at home. CONCLUSIONS: Results demonstrate how immunotherapy can impact the QoL of both patients and carers, either directly through toxicities or indirectly through mechanisms such as stress, financial toxicity, or fatigue that limits participation in life activities. IMPLICATIONS FOR PRACTICE: Supportive care resources and interventions are needed for those receiving immunotherapy to minimise negative impacts on QoL. Carers likewise require better preparation and information to assist in identifying potential treatment toxicities and ensure patient safety.

Exercise Behaviors and Fatigue in Patients Receiving Immunotherapy for Advanced Melanoma: A Cross-Sectional Survey via Social Media.

Objective: Treatment with immunotherapy has positively changed the long-term outlook of many patients with advanced melanoma; however, fatigue is a common and debilitating side effect. Evidence indicates exercise can improve treatment-related fatigue for patients receiving chemotherapy and radiotherapy. However, currently little is known about exercise behaviors and preferences of patients receiving immunotherapy. This project aimed to describe self-reported levels of fatigue related to immunotherapy; patient perspectives of exercise behaviors; and barriers and facilitators to engagement in exercise for patients receiving, or recently completed immunotherapy for unresectable stage III and stage IV melanoma. Method: A cross-sectional purpose-built survey was distributed to members of the Melanoma Patients Australia closed Facebook group via an online survey platform. The survey remained active for 1 month, with 3 posts during this time inviting members to participate. Results: A total of 55 responses were collected. Just over half the participants (n = 31; 56%) described exercising while receiving immunotherapy, with walking as the most common activity (n = 24; 77%). Participants described a range of physical and emotional benefits of exercise, the most predominant being fatigue reduction. Barriers to exercise also included fatigue and competing physical demands at home or work. Patient understanding of what constitutes exercise appeared to differ from clinical classifications. Conclusions: Results from this study indicate that patients are engaging in exercise while receiving immunotherapy, with the intent of mediating treatment-related fatigue. Identification of preferred exercise activities and barriers will assist in developing tailored exercise interventions for this cohort.

Australian Indigenous Communities: Efforts to Improve Cancer Care.

Aboriginal and Torres Strait Islander people are the Indigenous inhabitants of Australia who face many inequities regarding cancer care and outcomes. They are more likely to be diagnosed with cancer than non-Indigenous Australians and have not experienced the improvement in survival that non-Indigenous Australians have.

The survivorship experience for patients with metastatic melanoma on immune checkpoint and BRAF-MEK inhibitors.

PURPOSE: Immune checkpoint inhibitors (ICI) and BRAF and MEK inhibitors (BMi) have improved survival in metastatic melanoma (MM). However, the experience of long-term responders remains undescribed. This study characterised survivorship issues faced by long-term responders to ICI or BMi. METHODS: Patients with MM, aged ≥ 18 years old, ≥ 6 months post-ICI or BMi initiation with an objective response or stable disease. A 72-question survey assessed physical and psychological effects, impact on lifestyle, access to information, satisfaction with care, and availability of supports. RESULTS: One hundred and five of 120 (88%) patients completed the survey (ICI 69/BMI 36). For the ICI cohort, 39 (57%) were receiving ongoing treatment, 17 ceased due to toxicity and 13 due to a sustained response. For the BMi cohort, 31 (85%) were receiving ongoing treatment, 4 ceased due to toxicity and 1 due to a sustained complete response. At data cut-off on 18 December 2018, median PFS (range) was 2.5 years (1.3-8.5) for ICI and 3.1 years (0.6-7.3) for BMi. Long-term toxicities included dry/itchy skin (ICI 51, 74%/ BMi 25, 69%), arthralgias (ICI 30, 58%/ BMi 23, 64%) and fatigue (ICI 62, 90%/ BMi 33, 92%). Psychological morbidity was common, including anxiety awaiting results (ICI 50, 72%/ BMi 29, 81%), fear of melanoma recurring or progressing (ICI 56, 81%/ BMi 31, 86%) or death (ICI 44, 64%/ BMi 26, 72%). CONCLUSION: MM survivors experience chronic treatment toxicities and frequently report psychological concerns. IMPLICATIONS FOR CANCER SURVIVORS: Survivors may benefit from discussions regarding long-term toxicities and tailored psychological supports.

Negative Sentinel Lymph Node Biopsy in Patients with Melanoma: The Patient's Perspective.

BACKGROUND: The majority of patients undergoing sentinel lymph node biopsy (SLNB) for melanoma will have a negative SLN. The long-term sequelae of a negative result are important when discussing this staging investigation with patients. The objective of this study was to assess rates of lymphoedema and quality of life for these patients. METHODS: A prospective, cross-sectional study was performed on patients under routine follow-up with a history of melanoma, who had undergone sentinel lymph node biopsy where no metastasis was found (N0) at a high-volume melanoma centre. Relevant limbs were measured to assess for lymphoedema and patients completed the FACT-M quality of life instrument and a study specific questionnaire. RESULTS: A total of 102 patients were recruited. Wound complications were observed in 25% and lymphoedema in 2% of patients. Physical and functional well-being scores were lowest in patients seen within 3 months of their SLNB. Functional well-being and quality of life improved over the 2 years following the procedure. CONCLUSIONS: SLNB has low complication rates. The procedure is associated with a short-term impact on patient quality of life and well-being. The vast majority of patients are pleased with the outcomes of this procedure and the information that it provides.

Balancing the Hype with Reality: What Do Patients with Advanced Melanoma Consider When Making the Decision to Have Immunotherapy?

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.

Finding My Way: results of a multicentre RCT evaluating a web-based self-guided psychosocial intervention for newly diagnosed cancer survivors.

PURPOSE: This multicentre randomised controlled trial examined the efficacy of Finding My Way (FMW), a 6-week/6-module online self-guided psychotherapeutic intervention for newly diagnosed curatively treated cancer survivors, in reducing cancer-related distress and improving quality of life compared to an online attention control. METHODS: Participants were randomised on a 1:1 ratio using a gender-stratified block design to intervention (n = 94) or attention control (n = 97), and were blinded to condition. Assessments were completed at baseline (T0), post-intervention (T1), 3 months (T2), and 6 months (T3) post-intervention. Mixed model repeated measures analyses examined differences between groups for cancer-specific distress (primary outcome) and general distress, quality of life (QoL), coping, and health service utilisation (secondary outcomes). RESULTS: While both groups reported reduced cancer-specific and general distress over time, between-group differences were not significant. Intervention participants reported lower total health service utilisation and supportive care utilisation post-intervention than controls (total HS use: between-group mean difference = - 1.07 (- 1.85 to - 0.28); supportive care use: between-group mean difference = - 0.64 (- 1.21 to - 0.06)) and significantly higher emotional functioning at 3 months (between-group mean difference = 7.04 (0.15 to 13.9)). At 6 months, the supportive care utilisation finding reversed (between-group mean difference = 0.78 points (0.19 to 1.37). Across remaining QoL and coping outcomes, no significant group differences emerged. CONCLUSIONS: While both groups experienced reductions in distress, between-group differences were not significant. This contrasts with the significantly improved emotional functioning observed in FMW participants at 3 months and the short-term reductions in health service utilisation. Long-term increases in supportive care service utilisation suggest FMW only met needs while being actively used. TRIAL REGISTRATION: ACTRN12613000001796;  http://www.ANZCTR.org.au/ACTRN12613000001796.aspx.