Does the cost of cancer care for people in prison differ from those in the general population? Analysis of matched English cancer registry and hospital records.

Background: People in prison experience poorer mental and physical health compared to their peers in the general population. The causes are multi-dimensional ranging from lifestyle factors to poorer access to healthcare. Little is known about cancer in people in prison or how the cost of their care compares to the general population. Methods: Data on people diagnosed with cancer while in English prisons were identified in National Cancer Registration dataset and linked to Hospital Episode Statistics (HES) for the years 2012-2017. General population matched patients were identified using a 1-5 ratio, based on age, gender, year of diagnosis, cancer type and disease stage. Outpatient and inpatient HES data up to six-months from diagnosis were costed using NHS Reference costs and inflated to 2017/2018 costs. Findings: 879 prison and 4326 general population cancer diagnoses were identified in HES. The adjusted six-month cost of cancer care was significantly lower for people in prison (-£1216.95% confidence interval (CI) -1638 to -795), driven by fewer outpatient attendances. However, people diagnosed in prison had higher emergency care costs (£497.95% CI 375-619). Security escorts further increased the total cost of care. Interpretation: Following a cancer diagnosis, people in English prisons have significantly lower planned care costs, but higher emergency care costs and an overall higher cost due to security escorts. Further work is required to identify ways of improving cancer care for people in prisons to ensure it is equivalent to that received by the general population. Funding: National Institute for Health and Social Care Research 16/52/53.

Cancer in prison: barriers and enablers to diagnosis and treatment.

Background: Approximately 82,000 people are in prison annually in England and Wales. Limited research has investigated cancer in this population and none has explored experiences of imprisoned people with cancer. This study aimed to address this gap. Methods: We conducted 55 semi-structured, qualitative, audio-recorded interviews with: imprisoned people with cancer (n = 24), custodial staff (n = 6), prison healthcare staff (n = 16) and oncology specialists (n = 9). Data were collected 07/10/2019-20/03/2020. Patients were recruited by prison healthcare staff and interviews were conducted face-to-face. Professionals were recruited via professional networks and interviews were conducted face-to-face or via telephone. Transcribed interviews were analysed using reflexive thematic analysis. We also analysed relevant National Cancer Patient Experience Survey (NCPES) questions for those diagnosed in prison (n = 78) and in the general population (n = 390). Findings: Our findings highlight the complexities of cancer care for imprisoned people. We identified three core themes: control and choice, communication, and care and custody. Whilst people in prison follow a similar diagnostic pathway to those in the community, additional barriers to diagnosis exist including health literacy, the General Practitioner appointment booking system and communication between prison and oncology staff. Tensions between control and choice in prison impacted aspects of cancer care experience such as symptom management and accessing cancer information. NCPES results supported the qualitative findings and showed people in prison reported significantly poorer experiences than in the general population. Interpretation: Our findings demonstrate the complexity of cancer care in custodial settings, identifying barriers and enablers to equitable cancer care provision and offering insights on how to improve care for this population. Funding: National Institute for Health and Social Care Research Delivery Research Programme 16/52/53 and Strategic Priorities Fund 2019/20 Research England via University of Surrey.

Patients' and Clinicians' Perceptions of the Clinical Utility of Predictive Risk Models for Chemotherapy-Related Symptom Management: Qualitative Exploration Using Focus Groups and Interviews.

BACKGROUND: Interest in the application of predictive risk models (PRMs) in health care to identify people most likely to experience disease and treatment-related complications is increasing. In cancer care, these techniques are focused primarily on the prediction of survival or life-threatening toxicities (eg, febrile neutropenia). Fewer studies focus on the use of PRMs for symptoms or supportive care needs. The application of PRMs to chemotherapy-related symptoms (CRS) would enable earlier identification and initiation of prompt, personalized, and tailored interventions. While some PRMs exist for CRS, few were translated into clinical practice, and human factors associated with their use were not reported. OBJECTIVE: We aim to explore patients' and clinicians' perspectives of the utility and real-world application of PRMs to improve the management of CRS. METHODS: Focus groups (N=10) and interviews (N=5) were conducted with patients (N=28) and clinicians (N=26) across 5 European countries. Interactions were audio-recorded, transcribed verbatim, and analyzed thematically. RESULTS: Both clinicians and patients recognized the value of having individualized risk predictions for CRS and appreciated how this type of information would facilitate the provision of tailored preventative treatments or supportive care interactions. However, cautious and skeptical attitudes toward the use of PRMs in clinical care were noted by both groups, particularly in relationship to the uncertainty regarding how the information would be generated. Visualization and presentation of PRM information in a usable and useful format for both patients and clinicians was identified as a challenge to their successful implementation in clinical care. CONCLUSIONS: Findings from this study provide information on clinicians' and patients' perspectives on the clinical use of PRMs for the management of CRS. These international perspectives are important because they provide insight into the risks and benefits of using PRMs to evaluate CRS. In addition, they highlight the need to find ways to more effectively present and use this information in clinical practice. Further research that explores the best ways to incorporate this type of information while maintaining the human side of care is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT02356081; https://clinicaltrials.gov/study/NCT02356081.

Cancer incidence, treatment, and survival in the prison population compared with the general population in England: a population-based, matched cohort study.

BACKGROUND: The growing and ageing prison population in England makes accurate cancer data of increasing importance for prison health policies. This study aimed to compare cancer incidence, treatment, and survival between patients diagnosed in prison and the general population. METHODS: In this population-based, matched cohort study, we used cancer registration data from the National Cancer Registration and Analysis Service in England to identify primary invasive cancers and cervical cancers in situ diagnosed in adults (aged ≥18 years) in the prison and general populations between Jan 1, 1998, and Dec 31, 2017. Ministry of Justice and Office for National Statistics population data for England were used to calculate age-standardised incidence rates (ASIR) per year and age-standardised incidence rate ratios (ASIRR) for the 20-year period. Patients diagnosed with primary invasive cancers (ie, excluding cervical cancers in situ) in prison between Jan 1, 2012, and Dec 31, 2017 were matched to individuals from the general population and linked to hospital and treatment datasets. Matching was done in a 1:5 ratio according to 5-year age group, gender, diagnosis year, cancer site, and disease stage. Our primary objectives were to compare the incidence of cancer (1998-2017); the receipt of treatment with curative intent (2012-17 matched cohort), using logistic regression adjusted for matching variables (excluding cancer site) and route to diagnosis; and overall survival following cancer diagnosis (2012-17 matched cohort), using a Cox proportional hazards model adjusted for matching variables (excluding cancer site) and route to diagnosis, with stratification for the receipt of any treatment with curative intent. FINDINGS: We identified 2015 incident cancers among 1964 adults (1556 [77·2%] men and 459 [22·8%] women) in English prisons in the 20-year period up to Dec 31, 2017. The ASIR for cancer for men in prison was initially lower than for men in the general population (in 1998, ASIR 119·33 per 100 000 person-years [95% CI 48·59-219·16] vs 746·97 per 100 000 person-years [742·31-751·66]), but increased to a similar level towards the end of the study period (in 2017, 856·85 per 100 000 person-years [675·12-1060·44] vs 788·59 per 100 000 person-years [784·62-792·57]). For women, the invasive cancer incidence rate was low and so ASIR was not reported for this group. Over the 20-year period, the incidence of invasive cancer for men in prison increased (incidence rate ratio per year, 1·05 [95% CI 1·04-1·06], during 1999-2017 compared with 1998). ASIRRs showed that over the 20-year period, overall cancer incidence was lower in men in prison than in men in the general population (ASIRR 0·76 [95% CI 0·73-0·80]). The difference was not statistically significant for women (ASIRR 0·83 [0·68-1·00]). Between Jan 1, 2012, and Dec 31, 2017, patients diagnosed in prison were less likely to undergo curative treatment than matched patients in the general population (274 [32·3%] of 847 patients vs 1728 [41·5%] of 4165; adjusted odds ratio (OR) 0·72 [95% CI 0·60-0·85]). Being diagnosed in prison was associated with a significantly increased risk of death on adjustment for matching variables (347 deaths during 2021·9 person-years in the prison cohort vs 1626 deaths during 10 944·2 person-years in the general population; adjusted HR 1·16 [95% CI 1·03-1·30]); this association was partly explained by stratification by curative treatment and further adjustment for diagnosis route (adjusted HR 1·05 [0·93-1·18]). INTERPRETATION: Cancer incidence increased in people in prisons in England between 1998 and 2017, with patients in prison less likely to receive curative treatments and having lower overall survival than the general population. The association with survival was partly explained by accounting for differences in receipt of curative treatment and adjustment for diagnosis route. Improved routine cancer surveillance is needed to inform prison cancer policies and decrease inequalities for this under-researched population. FUNDING: UK National Institute for Health and Care Research, King's College London, and Strategic Priorities Fund 2019/20 of Research England via the University of Surrey.

Symptomatic presentation of cancer in primary care: a scoping review of patients' experiences and needs during the cancer diagnostic pathway.

OBJECTIVES: The objective was to map the experiences and needs of patients presenting with symptoms of suspected cancer in the primary care interval (from when they first present to primary care to their first appointment or referral to a secondary or tertiary level healthcare facility). DESIGN: This was a scoping review. INCLUSION CRITERIA: Studies or reports written in English which included primary data on the primary care interval experiences and/or needs of adult patients presenting with new symptoms of suspected cancer were eligible. Studies which only included patients with secondary or recurring cancer, conference abstracts and reviews were excluded. No date limits were applied. METHODS: The Joanna Briggs Institute method for Scoping Reviews guided screening, report selection and data extraction. At least two independent reviewers contributed to each stage. Medline, CINAHL, PsychInfo, Embase and Web of Science were searched and several grey literature resources. Relevant quantitative findings were qualitised and integrated with qualitative findings. A thematic analysis was carried out. RESULTS: Of the 4855 records identified in the database search, 18 were included in the review, along with 13 identified from other sources. The 31 included studies were published between 2002 and 2023 and most (n=17) were conducted in the UK. Twenty subthemes across four themes (patient experience, interpersonal, healthcare professional (HCP) skills, organisational) were identified. No studies included patient-reported outcome measures. Patients wanted (1) to feel heard and understood by HCPs, (2) a plan to establish what was causing their symptoms, and (3) information about the next stages of the diagnostic process. CONCLUSIONS: Scoping review findings can contribute to service planning as the cancer diagnostic pathway for symptomatic presentation of cancer evolves. The effectiveness of this pathway should be evaluated not only in terms of clinical outcomes, but also patient-reported outcomes and experience, along with the perspectives of primary care HCPs.

Mini-AFTERc: a controlled pilot trial of a nurse-led psychological intervention for fear of breast cancer recurrence.

OBJECTIVES: To determine the feasibility and acceptability of implementing the Mini-AFTERc intervention. DESIGN: Non-randomised cluster-controlled pilot trial. SETTING: Four NHS out-patient breast cancer centres in Scotland. PARTICIPANTS: Ninety-two women who had successfully completed primary treatment for breast cancer were screened for moderate levels of fear of cancer recurrence (FCR). Forty-five were eligible (17 intervention and 28 control) and 34 completed 3-month follow-up (15 intervention and 21 control). INTERVENTION: Mini-AFTERc, a single brief (30 min) structured telephone discussion with a specialist breast cancer nurse (SBCN) trained to target the antecedents of FCR. OUTCOMES: Feasibility and acceptability of Mini-AFTERc and the study design were assessed via recruitment, consent, retention rates, patient outcomes (measured at baseline, 2, 4, and 12 weeks), and post-study interviews with participants and SBCNs, which were guided by Normalisation Process Theory. RESULTS: Mini-AFTERc was acceptable to patients and SBCNs. SBCNs believe the implementation of Mini-AFTERc to be feasible and an extension of discussions that already happen routinely. SBCNs believe delivery, however, at the scale required would be challenging given current competing demands for their time. Recruitment was impacted by variability in the follow-up practices of cancer centres and COVID-19 lockdown. Consent and follow-up procedures worked well, and retention rates were high. CONCLUSIONS: The study provided invaluable information about the potential challenges and solutions for testing the Mini-AFTERc intervention more widely where limiting high FCR levels is an important goal following recovery from primary breast cancer treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT0376382 . Registered on 4 December 2018.

The "Breast-4Y" web app for breast cancer prevention at young age: Development, evaluation, and validation.

Background: Improving knowledge of risk factors, signs and symptoms positively influence an individual's intention to acquire healthy lifestyle behaviors to prevent breast cancer, to identify breast cancer risk early and seek health advice early. The aim of the present study was to develop and to assess the usability and quality of a web-app (Breast-4Y) designed specifically for younger women to improve their knowledge about breast cancer risk factors and symptoms as well as protective behaviors to reduce their risk. Methods: The development of the Breast-4Y web-app, based on Health Belief Model and the Behaviour Change Wheel, comprised four steps: i) analysis of scientific literature regarding breast cancer risk factors, symptoms and preventive lifestyle behaviors; ii) design of web-app; iii) content review by experts; iv) quality and usability assessment by the end-users (n = 20). Web-app usability was evaluated using the Spanish version of the System Usability Scale for the Assessment of Electronic Tools and the quality using the Spanish version of uMARS. Results: The contents were rated 4.25 or above, indicating high content quality. The mean usability score was 84.9 (SD 12.4), the mean rating for objective quality and subjective quality dimensions mean were 4.2 (SD 0.4) and 3.4 (0.777) respectively, indicating excellent usability and quality. Positive associations (p < .05) were observed between numbers of app used and attitudes to change (r = 0.479), and intention to change (r = 0.539). Strong positive associations (p < .001) were also observed between usability satisfaction and attitudes to change (r = 0.584), intention to change (r = 0.656), and help-seeking (r = 0.656). Conclusions: This study provided evidence that Breast-4Y has adequate contents, high quality, and usability. Breast-4Y can be tested in pragmatic trials to assess their effectiveness to reduce the risk of breast cancer, raise women's awareness of breast cancer risk factors, increase women's knowledge of breast cancer symptoms, and adopt protective lifestyle behaviors.

What do we know about the psychosocial issues associated with cancer during pregnancy? A scoping review and gap analysis.

OBJECTIVES: There is a global increase in the number of women diagnosed with cancer during their pregnancy and a nascent evidence base to guide their supportive care. The purposes of this study were to (1) map research on the psychosocial issues affecting women and their partners on diagnosis and treatment for cancer during pregnancy; (2) determine available supportive care or educational interventions; and (3) identify knowledge gaps for future research and development. DESIGN: Scoping review. SEARCH STRATEGY: Six databases were searched (Scopus, CINAHL, PsycINFO, Medline, Intermid, Maternal and Infant Health) to retrieve primary research (January 1995 to November 2021) investigating women and/or their partner's decision-making and their psychosocial outcomes during and after pregnancy. DATA EXTRACTION AND SYNTHESIS: Sociodemographic, gestational and disease characteristics of participants and psychosocial issues identified were extracted. Leventhal's self-regulatory model of illness provided a framework for mapping study findings enabling evidence synthesis and gap analysis. RESULTS: Twelve studies were included, conducted in eight countries in six continents. Most women (70% of 217) were diagnosed with breast cancer during pregnancy. Reporting of sociodemographic, psychiatric, obstetric and oncological characteristics that are important in assessing psychosocial outcomes was inconsistent. None of the studies had a longitudinal design and no supportive care or educational interventions were identified. The gap analysis highlighted the lack of evidence about pathways to diagnosis, impact of late effects and how internal/social resources may affect outcomes. CONCLUSIONS: Research has focused on women with gestational breast cancer. Little is known about those diagnosed with other cancers. We encourage future study designs to capture data on sociodemographic, obstetric, oncological and psychiatric characteristics and adopt a longitudinal approach to explore the longer term psychosocial impact on women and their families. Future research should include outcomes that are meaningful for women (and their partners) and draw on international collaboration to accelerate progress in this field.

Perceptions and experiences of the subjective well-being of people with glioblastoma: a longitudinal phenomenological study.

Background: Glioblastoma (GBM) is a devastating form of brain cancer, with a short life expectancy. In addition to this poor prognosis, people with GBM often experience symptoms that may have a profound impact on their subjective well-being (SWB). The aim of this study was to investigate the lived experiences and perceptions of people with GBM regarding their SWB. Methods: The study adopted a longitudinal, hermeneutical phenomenological approach. Twenty-seven interviews were conducted with 15 patients over a period of two years. Most participants were interviewed twice on a face-to-face basis (during combined chemotherapy and radiotherapy, and again during adjuvant chemotherapy). The hermeneutic circle was used to guide data analysis. Results: Data analysis identified four key themes that depicted the lived experiences and perceptions of SWB of people with GBM. "Experience of the disease" focuses on the impact of diagnosis, symptoms and side effects. "Daily life" relates to daily activities, family roles, work and social lives. "Coping" includes the importance of normality and goal-setting. "Experiences of care" focuses on the impact of the treatment schedule, experiences of care and impressions of the monitoring of QoL. Conclusion: SWB is affected by a variety of factors throughout the GBM disease and treatment journey. The findings of this study suggest that healthcare professionals can enhance the SWB of people with GBM by providing personalized care that supports people to set themselves goals for the future and retain a degree of normality wherever possible.

A systematic review of behavioural and exercise interventions for the prevention and management of chemotherapy-induced peripheral neuropathy symptoms.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) can result in functional difficulties. Pharmacological interventions used to prevent CIPN either show low efficacy or lack evidence to support their use and to date, duloxetine remains the only recommended treatment for painful CIPN. Non-pharmacological interventions such as exercise and behavioural interventions for CIPN exist. PURPOSE: The aims were to (1) identify and appraise evidence on existing behavioural and exercise interventions focussed on preventing or managing CIPN symptoms, (2) describe psychological mechanisms of action by which interventions influenced CIPN symptoms, (3) determine the underpinning conceptual models that describe how an intervention may create behaviour change, (4) identify treatment components of each intervention and contextual factors, (5) determine the nature and extent of patient and clinician involvement in developing existing interventions and (6) summarise the relative efficacy or effectiveness of interventions to lessen CIPN symptoms and to improve quality of life, balance and muscle strength. METHODS: A systematic search of Ovid Medline, Cochrane Library, EMBASE, PsycINFO, Health Management Information Consortium, Global Health and CINAHL was performed to identify articles published between January 2000 to May 2020, followed by OpenGrey search and hand-searching of relevant journals. Studies that explored behavioural and/or exercise interventions designed to prevent or improve symptoms of CIPN in adults who had received or were receiving neurotoxic chemotherapy for any type of cancer, irrespective of when delivered within the cancer pathway were included. RESULTS: Nineteen randomised controlled trials and quasi-experimental studies which explored behavioural (n=6) and exercise (n=13) interventions were included. Four studies were rated as methodologically strong, ten were moderate and five were weak. Ten exercise and two behavioural interventions, including those that improved CIPN knowledge and self-management resources and facilitated symptom self-reporting, led to reduced CIPN symptoms during and/or after chemotherapy treatment. CONCLUSIONS: The extent of potential benefits from the interventions was difficult to judge, due to study limitations. Future interventions should incorporate a clear theoretical framework and involve patients and clinicians in the development process. IMPLICATIONS FOR CANCER SURVIVORS: Our findings show exercise interventions have beneficial effects on CIPN symptoms although higher quality research is warranted. Behavioural interventions that increase patient's CIPN knowledge, improve self-management capacity and enable timely access to symptom management led to reduced CIPN symptoms.

Co-designing a behavioural intervention for reducing the impact of chemotherapy-induced peripheral neuropathy symptoms: An evidence- and theory-driven approach.

OBJECTIVE: This study aims to co-design an evidence- and theory-based behavioural intervention to reduce the impact of chemotherapy-induced peripheral neuropathy (CIPN) symptoms on patients' quality of life. METHODS: Guided by the Medical Research Council Framework for developing and evaluating complex interventions, our intervention development process was guided by (a) findings of systematic reviews, (b) inductive analysis of 39 h of observational fieldwork, 12 patient and 11 clinician interviews, (c) deductive analysis using the Common-Sense Model to develop a Self-Regulation Model of CIPN and (d) 17 patients and 18 clinicians co-designing the intervention. RESULTS: CIPN perception and coping behaviours were highlighted as processes to target when co-designing an intervention. The processes targeted in our intervention are CIPN perception and coping behaviours, namely, (a) self-monitoring of symptoms, (b) communicating and early reporting of symptoms to clinicians, (c) participating in making chemotherapy dose reduction decisions with their clinicians and (d) engaging in self-management and safety strategies to reduce impact of CIPN symptoms. To address these, a behavioural intervention was deemed suitable. CONCLUSION: We developed a self-regulation model of CIPN and a logic model for documenting the proposed mechanism of action of our co-designed behavioural intervention for reducing impact of CIPN symptoms.

Co-designing a cancer care intervention: reflections of participants and a doctoral researcher on roles and contributions.

BACKGROUND: Patient and Public Involvement is most usually framed in the context of designing, conducting and/or disseminating research. Participatory methods such as Experience-Based Co-Design (EBCD) further allow service users to directly engage in developing, testing and implementing interventions and services alongside healthcare staff. This paper aims to explore how participants in an EBCD project came-over time-to perceive their role and involvement in co-designing a cancer care intervention. METHODS: The findings are based on our reflections, a research diary, email correspondence and fieldnotes from co-design events. Co-design participants who attended most of the ten co-design events took part through written reflections or audio-recorded video calls. Ten reflective pieces were collected from clinicians (n = 4), PPI group members/patient participants (n = 4), a doctoral researcher (n = 1) and a visual illustrator (n = 1). Inductive data analysis of participant reflections was carried out using reflexive thematic analysis. Meeting fieldnotes, email correspondence and the researcher's diary were deductively analysed using the initial themes generated from this inductive analysis. RESULTS: Five main themes were identified: (1) changing perception of roles during the co-design process, (2) defining a 'co-designer', (3) engagement and ownership, (4) role of the research facilitator in maintaining momentum, and (5) perceived benefits of involvement. CONCLUSION: Our findings show the changing perceptions of roles and contributions among participants over time. Patients typically described their role as co-designers in terms simply of sharing their experiences. In contrast, clinicians perceived themselves as co-designers because they were working with patients who were actively involved in decision-making. Levels of engagement were affected by several factors such as time and facilitation, but most participants came to view themselves as co-owners of the intervention. Overall, participants perceived their involvement as a positive experience with clinicians also reporting wider positive impacts on their clinical practice.

Experience-Based Co-Design is a method for helping patients and clinicians work together to improve healthcare services. Studies of participant experiences in projects which use this method and how they perceive the co-designer role are rare. Our study explores how we­patients and clinicians­saw our role and participation as co-designers over time. Our findings are based on our written and verbal reflections of participating in a co-design project aimed at developing an information resource booklet and film for use in cancer care. We also analysed meeting records, email messages between participants and a reflective diary kept by the researcher who was coordinating the project. Our findings show that views of our roles and contributions as co-design participants changed over time. Patients tended to see themselves as 'co-designers' simply because they shared their experiences throughout the co-design process. In contrast, clinicians saw themselves as 'co-designers' because they were working together with patients and making decisions with them. Factors such as time demands, and the skill of the facilitator affected the commitment of participants to co-design activities. Most participants regard the ownership of the newly developed information resources as being shared. Overall, we viewed our participation in the co-design project as a positive experience with results that will benefit clinical practice.

Adapting a breast cancer early presentation intervention for Black women: A focus group study with women of Black African and Black Caribbean descent in the United Kingdom.

OBJECTIVE: Black women in the United Kingdom are more likely than White women to be diagnosed with advanced breast cancer and have lower survival rates. We consulted women of Black Caribbean and Black African descent in the United Kingdom on how the Promoting Early Presentation (PEP) booklet and intervention could be adapted for Black women to promote early presentation with breast cancer symptoms. METHODS: Focus groups with 22 women of Black African and Black Caribbean descent, of whom five had been treated for breast cancer. The participants were recruited from a large UK breast cancer charity and community settings. Data were analysed using Framework Analysis. RESULTS: Four themes summarised the participants' views on how the booklet and intervention could be adapted: Justify the focus on Black women, Black people do not talk about cancer, Make interventions inclusive and engaging, and Engage Black communities to deliver interventions. CONCLUSION: Breast cancer behaviour change interventions need to be more inclusive, illustrate how breast cancer symptoms manifest on black skin, and emphasise that breast cancer is curable to increase awareness and reduce cancer fear. Researchers should involve Black communities in the design and delivery of interventions to address appropriately cultural barriers to early presentation.

Clinician and patient experiences when providing and receiving information and support for managing chemotherapy-induced peripheral neuropathy: A qualitative multiple methods study.

OBJECTIVE: To improve patient experience of chemotherapy-induced peripheral neuropathy (CIPN), it is crucial to identify how patients develop their understanding and perception of CIPN. A wider understanding of the experiences of clinicians who provide CIPN information and support is also needed. This study explored clinician and patient experience of the provision of care, information and support for CIPN. METHODS: Data were collected between July and November 2019 using multiple qualitative methods. Non-participant observations were undertaken in colorectal and breast cancer clinics and at clinician stations, including the observation of chemotherapy consultations between patients and clinicians. Semi-structured interviews with people with cancer and clinicians were also conducted. Data were analysed using inductive reflexive thematic analysis. RESULTS: Three major themes emerged: (1) CIPN is a hidden chemotherapy side effect, (2) assessment and management of CIPN is disconnected and (3) patients and clinicians expect openness in CIPN symptom reporting, information provision and management. CONCLUSION: Findings show the need to address the lack of patients' overall familiarity with CIPN. Echoing earlier studies, our findings suggest that knowledge and understanding about CIPN among clinicians are limited or lacking. These insights from patient and clinicians' CIPN experiences can inform future interventions that may address the genuine needs of patients and enhance CIPN support.

Targeted self-management limits fatigue for women undergoing radiotherapy for early breast cancer: results from the ACTIVE randomised feasibility trial.

PURPOSE: The ACTIVE intervention uses a novel fatigue propensity tool to target a behavioural fatigue self-management programme for women undergoing radiotherapy for early breast cancer. We assess feasibility and outcomes for ACTIVE. METHODS: Mixed methods comprised a randomised feasibility trial with qualitative process evaluation and a nested fatigue risk substudy. Participants at a higher risk of fatigue were allocated 2:1 to behavioural intervention or information alone. Participants at a lower risk of fatigue entered the fatigue risk substudy. Feasibility was assessed by rates of eligibility, recruitment, retention and adherence. Qualitative interviews explored acceptability of the intervention and trial processes. Measures of fatigue, anxiety, depression, quality of life and self-efficacy were self-reported before, during and 10 days, 3 weeks and 6 months after radiotherapy. Pre-treatment fatigue risk score and post-treatment fatigue were correlated. RESULTS: Fifty percent (n = 75) of eligible patients were recruited with 33 higher risk participants randomised to the trial and 42 entering the fatigue risk score substudy. Trial design and methods were feasible and acceptable with 91% of participants completing all measures according to protocol. Fatigue was clinically-significantly lower in the intervention group during, and in the weeks after, treatment compared to the control: all secondary measures favoured the intervention group. Positive group differences were not maintained at 6 months. CONCLUSION: Our targeted approach to fatigue self-management is feasible and acceptable within the early breast cancer pathway. Multiple benefits were reported by patients who received the intervention, which is worthy of further investigation. TRIAL REGISTRATION: ISRCTN 10303368. Registered August 2017. Health and Care Research Wales Clinical Trial Portfolio Registration 31419.

An experimental study to identify key psychological mechanisms that promote and predict resilience in the aftermath of treatment for breast cancer.

OBJECTIVE: Women living with and beyond breast cancer (BC) frequently encounter cancer-related information in day-to-day life. The extent they are emotionally resilient to this information differs between women. Identifying key modifiable psychological mechanisms predicting resilience in these women could highlight targets for interventions to improve resilience in others. This study investigates resilience over time in women living beyond BC and how this relates to individual differences in the way the brain processes information. METHODS: Seventy women within a year of finishing first-line treatment for BC (clinical and community recruitment) completed computerised tasks to assess the tendency to attend to cancer information (dot-probe task), the tendency to draw negative cancer-related interpretations from ambiguous information (ambiguous scenarios task) and extent of executive functioning (attentional network task). Questionnaires were completed assessing resilience, and other clinically relevant psychological variables (fear of cancer recurrence, distress, quality of life, and worry) at the time of the laboratory tasks (T1) and again 6 months later (T2). RESULTS: The only cognitive process associated with self-reported resilience was interpretation bias. Generating more negative cancer-related interpretations of ambiguous information at T1 significantly predicted resilience at T2, whilst controlling for T1 resilience and other clinically relevant variables. Furthermore, resilience scores were relatively stable over time and moderately correlated with other clinically relevant variables. CONCLUSIONS: This study is the first to identify a key cognitive mechanism that predicts resilience in women living beyond BC. This finding suggests interventions to reduce cancer-related interpretations of ambiguous information could promote resilience in women living beyond BC.

International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: A qualitative study.

PURPOSE: Evidence suggests that the patient-reported outcome (PRO) content of cancer trial protocols is frequently inadequate and non-reporting of PRO findings is widespread. This qualitative study examined the factors influencing suboptimal PRO protocol content, implementation, and reporting, and use of PRO data during clinical interactions. METHODS: Semi-structured interviews were conducted with four stakeholder groups: (1) trialists and chief investigators; (2) people with lived experience of cancer; (3) international experts in PRO cancer trial design; (4) journal editors, funding panelists, and regulatory agencies. Data were analyzed using directed thematic analysis with an iterative coding frame. RESULTS: Forty-four interviews were undertaken. Several factors were identified that could influenced effective integration of PROs into trials and subsequent findings. Participants described (1) late inclusion of PROs in trial design; (2) PROs being considered a lower priority outcome compared to survival; (3) trialists' reluctance to collect or report PROs due to participant burden, missing data, and perceived reticence of journals to publish; (4) lack of staff training. Strategies to address these included training research personnel and improved communication with site staff and patients regarding the value of PROs. Examples of good practice were identified. CONCLUSION: Misconceptions relating to PRO methodology and its use may undermine their planning, collection, and reporting. There is a role for funding, regulatory, methodological, and journalistic institutions to address perceptions around the value of PROs, their position within the trial outcomes hierarchy, that PRO training and guidance is available, signposted, and readily accessible, with accompanying measures to ensure compliance with international best practice guidelines.

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART).

OBJECTIVE: To evaluate effects of remote monitoring of adjuvant chemotherapy related side effects via the Advanced Symptom Management System (ASyMS) on symptom burden, quality of life, supportive care needs, anxiety, self-efficacy, and work limitations. DESIGN: Multicentre, repeated measures, parallel group, evaluator masked, stratified randomised controlled trial. SETTING: Twelve cancer centres in Austria, Greece, Norway, Republic of Ireland, and UK. PARTICIPANTS: 829 patients with non-metastatic breast cancer, colorectal cancer, Hodgkin's disease, or non-Hodgkin's lymphoma receiving first line adjuvant chemotherapy or chemotherapy for the first time in five years. INTERVENTION: Patients were randomised to ASyMS (intervention; n=415) or standard care (control; n=414) over six cycles of chemotherapy. MAIN OUTCOME MEASURES: The primary outcome was symptom burden (Memorial Symptom Assessment Scale; MSAS). Secondary outcomes were health related quality of life (Functional Assessment of Cancer Therapy-General; FACT-G), Supportive Care Needs Survey Short-Form (SCNS-SF34), State-Trait Anxiety Inventory-Revised (STAI-R), Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer), and work limitations questionnaire (WLQ). RESULTS: For the intervention group, symptom burden remained at pre-chemotherapy treatment levels, whereas controls reported an increase from cycle 1 onwards (least squares absolute mean difference -0.15, 95% confidence interval -0.19 to -0.12; P<0.001; Cohen's D effect size=0.5). Analysis of MSAS sub-domains indicated significant reductions in favour of ASyMS for global distress index (-0.21, -0.27 to -0.16; P<0.001), psychological symptoms (-0.16, -0.23 to -0.10; P<0.001), and physical symptoms (-0.21, -0.26 to -0.17; P<0.001). FACT-G scores were higher in the intervention group across all cycles (mean difference 4.06, 95% confidence interval 2.65 to 5.46; P<0.001), whereas mean scores for STAI-R trait (-1.15, -1.90 to -0.41; P=0.003) and STAI-R state anxiety (-1.13, -2.06 to -0.20; P=0.02) were lower. CASE-Cancer scores were higher in the intervention group (mean difference 0.81, 0.19 to 1.43; P=0.01), and most SCNS-SF34 domains were lower, including sexuality needs (-1.56, -3.11 to -0.01; P<0.05), patient care and support needs (-1.74, -3.31 to -0.16; P=0.03), and physical and daily living needs (-2.8, -5.0 to -0.6; P=0.01). Other SCNS-SF34 domains and WLQ were not significantly different. Safety of ASyMS was satisfactory. Neutropenic events were higher in the intervention group. CONCLUSIONS: Significant reduction in symptom burden supports the use of ASyMS for remote symptom monitoring in cancer care. A "medium" Cohen's effect size of 0.5 showed a sizable, positive clinical effect of ASyMS on patients' symptom experiences. Remote monitoring systems will be vital for future services, particularly with blended models of care delivery arising from the covid-19 pandemic. TRIAL REGISTRATION: Clinicaltrials.gov NCT02356081.

Collaboration with people with lived experience of prison: reflections on researching cancer care in custodial settings.

BACKGROUND: Patient and public involvement is increasingly considered important in health research. This paper reflects, from both academic and lived experience perspectives, on involving people with lived experience in a study exploring cancer care in prison and how by doing this it enriched the research process. METHODS: This paper is based on written and verbal reflections of the lived experience researchers and academic researchers involved in a study exploring the diagnosis and treatment of people with cancer in prison. The study comprised interviews with people with cancer in prison, prison healthcare staff, oncology specialists and custodial staff. Lived experience researchers were involved throughout the research process, including co-conducting interviews with patients and analysing interviews. RESULTS: This paper highlights the importance and value of including lived experience researchers across the research process. We reflect on how lived experience of prison shapes the experience of conducting interviews and analysing data gathered in prison. We reflect on the working relationships between academic and lived experience researchers. We demonstrate how prison research is challenging, but collaboration between lived experience and academic researchers can help to better prepare for the field, to ask more meaningful questions and to create rapport with participants. These types of collaborations can be powerful avenues for skill development for both academic and lived experience researchers, but they require an investment of time and a willingness for shared learning. CONCLUSIONS: For academics and lived experience researchers to collaborate successfully and meaningfully care needs to be taken to develop open, honest and equal working relationships. Skills development for academic and lived experience researchers is important. A commitment to building and maintaining relationships is crucial. Having a third party as a mediator can facilitate and foster these relationships. Particularly with people with lived experience of prison it is essential to put the 'do no harm' principle into practice and to have support in place to minimise this.

While patient and public involvement is increasingly considered important in health research, very few papers reflect on the process of collaborating with people with lived experience of prison in health research. This paper is based on written and verbal reflections of both the lived experience and academic researchers on the project that explored how cancer is diagnosed and treated in prison. For academics and lived experience researchers to collaborate successfully and meaningfully care needs to be taken to develop open, honest and equal working relationships. Skills development for academic and lived experience researchers is important. A commitment to building and maintaining relationships is crucial. Having a third party as a mediator can facilitate and foster these relationships. Particularly with people with lived experience of prison it is essential to put the 'do no harm' principle into practice and to have support in place to minimise this. The process of writing this paper provided additional opportunities to reflect on the collaboration which we all found vital. Involving lived experience researchers on all aspects of the research process can strengthen the design, relevancy and outcomes of studies. The process, however, can be emotionally challenging for lived experience and academic researchers, underscoring the need for space for open and honest reflection and learning. Particularly for people with lived experience of prison, being involved in research studies can be a great source of personal growth as it offers an opportunity to use and reframe their, often traumatic, lived experience in a positive way.