Caregiver strain among relatives of out-of-hospital cardiac arrest survivors; The DANCAS relative survey.

BACKGROUND: Knowledge about caregiver strain among relatives of out-of-hospital cardiac arrest (OHCA) survivors is limited. Thus, the objectives were to i) describe differences in self-reported mental well-being, mental health, and caregiver strain at different time points (1-5 years) post-OHCA and ii) investigate characteristics associated with caregiver strain. METHODS: A national cross-sectional survey (DANCAS) from October 2020 to March 2021 with OHCA survivors and their closest relatives. The relative survey included the WHO-5 Well-being Index (WHO-5), the Hospital Anxiety and Depression Scale (HADS) and the Modified Caregiver Strain Index (M-CSI). Differences in scores between time groups were explored using descriptive statistics. Associations between characteristics and caregiver strain were investigated with multivariable logistic regression models, presented as odds ratios (OR) with 95% confidence intervals (CI), adjusted for gender, age, education status, relative affiliation, and time after OHCA. RESULTS: Of 561 relatives, 24% (n=137) experienced caregiver strain, with no significant differences in the relatives' mental well-being, mental health, or caregiver strain with time since OHCA. In the adjusted analyses, older age (OR 0.98 95% CI 0.96;0.99) and several self-reported outcomes, including reduced mental well-being (WHO-5 OR 7.27 95% CI 4.86;11.52), symptoms of anxiety (HADS-A OR 6.01 95% CI 3.89;9.29) and depression (HADS-D OR 15.03 95% CI 7.33;30.80) were significantly associated with worse caregiver strain. CONCLUSION: Nearly one-quarter of relatives of OHCA survivors experience caregiver strain, with this proportion remaining unchanged with time. Several outcomes were associated with caregiver strain, emphasising the need to identify relatives at greater risk of burden following OHCA.

Health-Related Quality of Life in Danish Cancer Survivors Referred to a Late Effects Clinic: A Prospective Cohort Study.

PURPOSE: The Region of Southern Denmark has recently established four late effects clinics to help cancer survivors suffering from complex and severe late effects. This study aimed to capture and analyze the full range of physical, mental, and psychosocial issues using patient-reported outcomes. Moreover, we aimed to describe demographic data and the type and severity of the late effects. METHODS: A prospective cohort study was conducted among cancer survivors referred to a late effects clinic. Before their first appointment, patients completed the European Organization for Research and Treatment of Cancer Quality of Life cancer survivorship core questionnaire (EORTC QLQ-SURV100). We compared mean scores of the EORTC QLQ-SURV100 scales that were comparable to the scales/items from the EORTC QLQ-C30 questionnaire with norm data for the Danish population and EORTC reference values. RESULTS: All patients referred to the clinic within its first 2 years were included (n = 247). The mean age was 57 [23-85] years and 74% were females. The most common cancer diagnoses was breast cancer (39%). The five most commonly reported late effects were fatigue (66%), pain (51%), cognitive impairment (53%), sleep problems (42%), and neuropathy (40%). A total of 236 of the patients entering the clinic completed QLQ-SURV100. They reported significantly worse mean scores on all scales compared to the Danish norm population and EORTC reference values for pretreatment cancer patients, p < 0.001. Effect sizes were moderate or large for all scales. INTERPRETATION: In this study, we collected demographic data and described the late effects presented by the patents referred to the clinic. Moreover, we captured and analyzed the full range of physical, mental, and psychosocial issues using QLQ-SURV100. Patients referred to the Late Effects Clinic (LEC) had a number of late effects and reported a significantly lower health-related quality of life compared to the general Danish population and patients who have just been diagnosed with cancer, suggesting the aim of helping patients suffering from late effects gain a better quality of life is in dire need.

People affected by cancer and their carers from gender and sexually diverse communities: their experiences and the role of smartphone applications.

BACKGROUND: People living with cancer, or carers who are from lesbian, gay, bisexual, transgender, queer, intersex or asexual (LGBTQIA+) communities experience unique information and support needs. Accessible technology-based resources providing tailored support are required to promote wellbeing, however this is a growing area of research requiring further investigation. The purpose of this study was to explore the experiences of healthcare services among people living with cancer, and their carers, who belong to sexual or gender diverse communities (LGBTQIA+), and identify how smartphone applications (apps) could support people from LGBTQIA + communities. METHODS: This was a qualitative descriptive study where people living with cancer or carers from LGBTQIA + communities participated in phone interviews. Participants were recruited across Australia via social media advertisements, LGBTQIA + medical practices, and cancer advocacy groups. Participants were asked questions about their experiences, and were provided with screenshots of an existing app and asked to provide feedback on content and inclusiveness. Transcripts were coded and codes grouped together to form similar and concepts. Inductive and deductive analyses were used to create themes. RESULTS: 13 patients (mean age 56 (SD:13)), and three carers (mean age 64 (SD:19)) completed phone interviews. The majority of participants identified their gender as female (patients n = 9, carers 3), and their sexuality as gay or lesbian (patients n = 10, carers n = 3). Four themes were created: (1) navigating disclosure in healthcare, described emotional challenges surrounding disclosure; (2) the power of positive experiences with clinicians, described positive interactions and gaps in care from clinicians; (3) impact of gender and sexuality on informal support, outlined support received from informal network and gaps in support, and; (4) opportunities to increase inclusivity in smartphone apps, generated ideas on how apps can be tailored to meet needs identified. CONCLUSION: Disclosure of gender or sexuality, and interactions with clinicians had the potential to impact participants' experience of cancer care. Gaps in informal networks pointed at how to better support LGBTQIA + communities, and identified opportunities for inclusion in an app that will be tailored and trialled for this community. Future work should focus on addressing systems-level processes in acknowledging and supporting priority groups affected by cancer.

Usability and Evaluation of a Health Information System in the Emergency Department: Mixed Methods Study.

BACKGROUND: A lack of information during an emergency visit leads to the experience of powerlessness for patients and their family members, who may also feel unprepared to cope with acute symptoms. The ever-changing nature and fast-paced workflow in the emergency department (ED) often affect how health care professionals can tailor information and communication to the needs of the patient. OBJECTIVE: This study aimed to evaluate the usability and experience of a newly developed information system. The system was developed together with patients and their family members to help provide the information needed in the ED. METHODS: We conducted a mixed methods study consisting of quantitative data obtained from the System Usability Scale questionnaire and qualitative interview data obtained from purposively selected participants included in the quantitative part of the study. RESULTS: A total of 106 patients and 14 family members (N=120) answered the questionnaire. A total of 10 patients and 3 family members participated in the interviews. Based on the System Usability Scale score, the information system was rated close to excellent, with a mean score of 83.6 (SD 12.8). Most of the participants found the information system easy to use and would like to use it again. The participants reported that the system helped them feel in control, and the information was useful. Simplifications were needed to improve the user experience for the older individuals. CONCLUSIONS: This study demonstrates that the usability of the information system is rated close to excellent. It was perceived to be useful as it enabled understanding and predictability of the patient's trajectory in the ED. Areas for improvement include making the system more usable by older individuals. The study provides an example of how a technological solution can be used to diminish the information gap in an ED context.

Communicating without a Shared Language: A Qualitative Study of Language Barriers in Language-Discordant Cancer Communication.

We use language to achieve understanding, and language barriers can have major health consequences for patients with serious illness. While ethnic minorities are more likely to experience social inequalities in health and health care, communicative processes in language-discordant cancer care remain unexplored. This study aimed to investigate communication between patients with cancer and limited Danish proficiency and oncology clinicians, with special emphasis on how linguistic barriers influenced patient involvement and decision-making. 18 participant observations of clinical encounters were conducted. Field notes and transcriptions of audio recordings were analyzed, and three themes were identified: Miscommunication and uncertainty as a basic linguistic condition; Impact of time on patient involvement; Unequally divided roles and (mis)communication responsibilities. The results showed that professional interpreting could not eradicate miscommunication but was crucial for achieving understanding. Organizational factors related to time and professional interpreting limited patient involvement. Without professional interpreting, patients' relatives were assigned massive communication responsibilities. When no Danish-speaking relatives partook, clinicians' ethical dilemmas further increased as did patient safety risks. Language barriers have consequences for everyone who engages in health communication, and the generated knowledge about how linguistic inequality manifests itself in clinical practice can be used to reduce social inequalities in health and health care.

Healthcare interventions for older people with dementia and family caregivers in Europe: A scoping review.

AIM: This study aimed to examine the extent, range and variety of research in Europe describing healthcare interventions for older people with dementia (PwD) and family caregivers. METHODS: This was a scoping review and followed the PRISMA Scoping Review guideline. MEDLINE, CINAHL and Cochrane library databases were searched for studies published between 2010 and 2020. Studies reporting healthcare interventions in Europe for PwD over 65 years and their family caregivers were included. RESULTS: Twenty-one studies from six European countries were included. The types of healthcare intervention identified were categorized as follows: (1) family unit intervention (interventions for both PwD and their family caregiver), (2) individual intervention (separate interventions for PwD or family caregivers) and (3) family caregiver only intervention (interventions for family caregivers only but with outcomes for both PwD and family caregivers). CONCLUSIONS: This review provides insight into healthcare interventions for older PwD and family caregivers in Europe. More studies are needed that focus on the family as a unit of care in dementia.

Translation and Cross-Cultural Validation of the Danish Version of the Family Health Scale-Long Form: A Psychometric Study.

OBJECTIVES: The Family Health Scale is a new instrument for evaluating family health. The instrument is reported as valid and reliable in investigating family health among different types of adult family members. This study aimed to translate the Family Health Scale into Danish and investigate its validity and reliability in families with a family member affected by chronic or serious illness. DATA SOURCES: Translation was performed through forward and backward bilingual practice consisting of 10 steps. A cross-sectional study included 406 participants, of whom 94 also participated in a follow-up study within 3 weeks for the test-retest. Content validity was examined by conducting cognitive interviews with nine family members. Internal consistency reliability was assessed using Cronbach α. The test-retest reliability was evaluated using intraclass correlation coefficients. Model fit was assessed using confirmatory factor analysis. CONCLUSION: The Family Health Scale demonstrated good content validity and a moderate model fit. Both Internal consistency reliability and test-retest reliability were satisfying. Cronbach α ranged from 0.73 to 0.89, while the intraclass correlation coefficient value was 0.88. The confirmatory factor analysis estimated a satisfying model fit, with an acceptable root-mean-square error of 0.076 and a moderate comparative fit index of 0.794. IMPLICATION FOR NURSING PRACTICE: The Family Health Scale instrument has the potential to identify vulnerable families or families affected by chronic or serious illnesses, such as cancer. The assessment tool can consequently be used to target interventions to promote family health and improve the health of both the individual and his/her family.

Nursing Roles in Cancer Rehabilitation: An Integrative Review.

BACKGROUND: Because of cancer survivors' increased need for help and support, cancer rehabilitation should be an essential part of cancer treatment, where focusing on patients' individual needs is essential. OBJECTIVE: To provide an overview of existing evidence about nurses' roles and participation in cancer rehabilitation, based on both nurses' and patients' perspectives. METHODS: A systematic search was conducted in PubMed, CINAHL, EMBASE and Cochrane databases for studies published from January 2001-January 2022. Whittemore and Knafl's methodology for data extraction and synthesis was used, and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines were followed. The review was registered in PROSPERO (CRD42021223683). RESULTS: Ten qualitative studies and 7 quantitative studies were included, encompassing 306 patients and 1847 clinicians (1164 nurses). Three nursing roles emerged: (1) relationship-forming, in which nurses described ongoing involvement in patients' rehabilitation and patients described nurses as trusted partners; (2) coordinating, in which nurses described a lack of time and resources and a focus on medical treatment, and patients described nurses as expert coordinators; and (3) follow-up, in which patients described nurses as good communicators and trusted partners in their follow-up, and nurses described their natural interest in patients' rehabilitation outcomes during follow-up. CONCLUSIONS: Patients were comfortable with nurses as trusted partners during cancer rehabilitation. Significant barriers such as lack of time, resources, and education about rehabilitation may negatively influence rehabilitation planning, implementation, and monitoring. IMPLICATIONS FOR PRACTICE: Clinicians can use the findings to improve cancer rehabilitation with the nurse as a central provider and conduct further research on the coordinating and follow-up roles.

The Danish landscape of providing support for caregivers of people with potentially life-threatening disease: A cross-sectional study among representatives of health services in Danish municipalities and hospitals.

AIMS: (a) To investigate support for caregivers of people diagnosed with stroke, cancer, chronic obstructive pulmonary disease (COPD), dementia, or heart disease provided across healthcare settings in Denmark; (b) to assess differences in caregiver support across diagnoses and settings. METHODS: A cross-sectional nationwide survey among professionals representing healthcare settings at municipalities (n = 479) and hospital wards and outpatient clinics (n = 425). The survey assessed identification of caregivers and support initiatives. RESULTS: The response rate was 81% for municipalities and 49% for hospitals. Identification of caregivers was frequent in dementia care (81% and 100%) and less frequent in COPD care (58% and 64%) in municipalities and hospitals, respectively. Caregiver support differed significantly across diagnoses within municipalities (p = 0.009) and hospitals (p < 0.001). Systematic identification of vulnerable caregivers was <25% for all diagnoses except dementia. The most common support initiatives involving caregivers were primarily aimed at the ill person and included guidance about the disease and consequences for everyday life and lifestyle changes. Caregivers were least involved in support initiatives addressing physical training, work retention, sexuality, or cohabitation. CONCLUSIONS: Disparities and significant differences across diagnoses exist in the identification of caregivers and the provision of support initiatives. Support initiatives involving caregivers primarily targeted patients. Future studies should investigate how caregivers' needs can be met across different diagnoses and healthcare settings and investigate potential changes in caregivers' needs during disease trajectories. In clinical practice, identification of vulnerable caregivers should be a major focus, and disease-specific clinical guidelines may be required to ensure sufficient support for caregivers.

Protective Buffering: Nurses Facilitating Communication Between Adults With Cancer and Their Adult Family Caregivers Who Overprotect One Another-An Integrative Review.

The aim of this study was to explore how nurses can alleviate protective buffering between adult patients with cancer and their adult family caregivers (PROSPERO No. CRD42020207072). An integrative review was conducted. PubMed, CINAHL, Embase, and Cochrane Library were searched for primary research articles published between January 2010 and April 2022. Only research conducted in oncology, hematology, or multiple settings and investigating communication between adult patients with cancer and their adult family caregivers and/or the communication between patients, family caregivers, and nurses was included. The constant comparison method outlined the approach to the analysis and synthesis of the included studies. Titles and abstracts of 7,073 references were screened; 22 articles (19 qualitative and three quantitative studies) were included in the review. Three themes emerged during data analysis: (a) family coping, (b) an isolating journey, and (c) the nurse's role. A study limitation was that "protective buffering" is not a common term in the nursing literature. There is a need for further research on protective buffering in families with cancer, particularly on psychosocial interventions that focus on the whole family across various cancer types.

An Overview of the Fundamentals of Data Management, Analysis, and Interpretation in Quantitative Research.

OBJECTIVES: To provide an overview of three consecutive stages involved in the processing of quantitative research data (ie, data management, analysis, and interpretation) with the aid of practical examples to foster enhanced understanding. DATA SOURCES: Published scientific articles, research textbooks, and expert advice were used. CONCLUSION: Typically, a considerable amount of numerical research data is collected that require analysis. On entry into a data set, data must be carefully checked for errors and missing values, and then variables must be defined and coded as part of data management. Quantitative data analysis involves the use of statistics. Descriptive statistics help summarize the variables in a data set to show what is typical for a sample. Measures of central tendency (ie, mean, median, mode), measures of spread (standard deviation), and parameter estimation measures (confidence intervals) may be calculated. Inferential statistics aid in testing hypotheses about whether or not a hypothesized effect, relationship, or difference is likely true. Inferential statistical tests produce a value for probability, the P value. The P value informs about whether an effect, relationship, or difference might exist in reality. Crucially, it must be accompanied by a measure of magnitude (effect size) to help interpret how small or large this effect, relationship, or difference is. Effect sizes provide key information for clinical decision-making in health care. IMPLICATIONS FOR NURSING PRACTICE: Developing capacity in the management, analysis, and interpretation of quantitative research data can have a multifaceted impact in enhancing nurses' confidence in understanding, evaluating, and applying quantitative evidence in cancer nursing practice.

Impact of patient-reported outcomes on symptom monitoring during treatment with checkpoint inhibitors: health-related quality of life among melanoma patients in a randomized controlled trial.

INTRODUCTION: In a randomized controlled trial, we previously investigated if melanoma patients receiving checkpoint inhibitors had fewer severe immune-related adverse events (irAEs) when they reported symptoms using electronic patient-reported outcomes (ePRO) with triggered alerts as an add-on to standard care, compared to standard care alone. The aim of this study is to examine between-group differences in health-related quality of life (HRQoL) and associations between irAEs severity and HRQoL. METHODS: The study population of 138 patients completed the EuroQol EQ-5D-5L Index and FACT-M questionnaires at baseline and weeks 24 and 48. We analyzed HRQoL from all patients who completed at least one questionnaire. Missing FACT-M items were imputed following existing guidelines. RESULTS: There was no difference in HRQoL at baseline as measured EQ-5D-5L between the intervention and the control group. Between baseline and 48 weeks, mean EQ-5D-5L scores were unchanged among patients in the intervention group (p = 0.81) but decreased significantly among patients in the control group (p = 0.03). Consequently, patients in the intervention group had higher mean scores than those in the control group (p = 0.05) at 48 weeks. Mean FACT-M scores did not differ significantly between the two groups at any of the time points. There were observed no between-group differences in mean EQ-5D-5 and mean FACT-M scores between patients with severe irAEs and patients who had none. CONCLUSION: Melanoma patients receiving CPIs who self-reported irAEs using ePRO with triggered alerts as a supplement to standard care maintained their HRQoL compared to patients who received standard care alone. Patients in the intervention group had a significantly better HRQoL measured by EQ-5D-5L than controls 48 weeks after baseline. The results suggest that including ePRO in standard care increases melanoma patients´ well-being. Further and larger studies are needed to confirm this finding and examine the impact of severe irAEs on cancer patients' HRQoL. TRIAL REGISTRATION: Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered https://clinicaltrials.gov/ .

Patient, Family Caregiver, and Nurse Involvement in End-of-Life Discussions During Palliative Chemotherapy: A Phenomenological Hermeneutic Study.

The aim of this study was to investigate current nursing practice related to end-of-life discussions with incurable lung cancer patients and their family caregivers from the perspectives of patients, family caregivers, and nurses in an oncology outpatient clinic. This phenomenological hermeneutic study included nine patients, eight family caregivers, and 11 nurses. Data were collected using participant observation, informal and semi-structured individual or joint interviews with patients and family caregivers, and focus group interviews with nurses. A Ricoeur-inspired approach was used to analyze the data. Three themes were identified: (a) content of end-of-life discussions, (b) timing of end-of-life discussions, and (c) challenges in end-of-life discussions. End-of-life discussions were seldom initiated; when they were, it was often too late. Discussions addressed treatment, place of care, practical/economic concerns, and existential matters. The physical environment at the outpatient clinic, lack of continuity, and nurses' instrumental task workloads and time pressure posed challenges to initiating end-of-life discussions.

Evaluation of a multimodal rehabilitative palliative care programme for patients with high-grade glioma and their family caregivers.

BACKGROUND: Patients diagnosed with high-grade glioma and their family caregivers often experience intense disease and treatment trajectories. Fluctuations in patient's symptoms lead to enormous burdens for caregivers and the risk of developing symptoms of stress, anxiety, and depression. AIM: The study aim is to explore patient and caregiver experiences and evaluate the relevance of and satisfaction with a multimodal rehabilitative palliative care programme for patients diagnosed with a high-grade glioma and their family caregivers. METHODS: In a longitudinal multi-methods study, adult patients with high-grade glioma (n = 17) and their family caregivers (n = 16) completed a 4-day residential programme and a 2-day follow-up programme 3 months later. Participants completed questionnaires after each programme, scoring relevance and satisfaction on a 5-point Likert scale. Qualitative data were collected during four evaluation group interviews with patients and caregivers. RESULTS: The mean overall satisfaction score was 4.80 (standard deviation [SD], 0.55) for the initial 4-day programme and 4.28 (SD, 0.83) for the follow-up programme. Three themes emerged in the evaluation group interviews: (1) meeting peers strengthens social well-being, (2) the value of information and focusing on individual needs, and (3) accepting life as an unpredictable passage. CONCLUSION: Participants found completing the REHPA-HGG programme feasible and rated all sessions highly for relevance and satisfaction. Qualitative findings confirm the value of individualised information, acceptance, and peer interactions. IMPLICATION FOR PRACTICE: A multimodal rehabilitative palliative care programme addressed unmet patient and caregiver needs. Peer-to-peer interventions for family caregivers may address individual support needs. Similar programmes may maximise benefit by avoiding planned behaviour changes and enhancing palliative approaches.

Healthcare practices and interventions in Europe towards families of older patients with cardiovascular disease: A scoping review.

BACKGROUND: In Europe, cardiovascular disease is one of the predominant causes of mortality and morbidity among older people over 65 years. The occurrence of cardiovascular disease can have a negative impact on the quality of life of older patients and their families and family health overall. Assuming that illness is a family affair shaped by culture and health care systems, we explored European health care practices and interventions toward families of older patients with cardiovascular disease and heart failure. AIMS: This paper aimed to determine the extent, range, and variety of practices and interventions in Europe directed to families of older patients and to identify knowledge gaps. MATERIALS & METHODS: A scoping review was conducted including studies published in Medline, CINHAL, or Cochrane library between 2009 and mid-2020. RESULTS: A total of 22 articles from 17 studies were included, showing diverse practices and interventions. The interventions targeted the family as a unit (six studies), dyads (five studies), patients alone, but assessed family members' reactions (five studies) or the family member primarily, but assessed the reaction of the patient (one study). Target outcomes were family caregiver burden; health-related QoL; and perceived control in patients; and family functioning and changes in health behavior or knowledge in both, family members and patients. Most studies did not include an integral view of the family as the unit of care but rather had a disease-centered approach. DISCUSSION: This scoping review provides insight into a variety of healthcare practices towards families of older patients with cardiovascular disease in Europe. Clarifying underlying assumptions to involve families is needed. More studies with family-focused approaches as integral models could lead to practices that improve families' well-being. Exploring integral models for their acceptance in health care and family systems appears pertinent to develop European policy to support and add to family health.

Health practices in Europe towards families of older patients with cancer: a scoping review.

INTRODUCTION: In Europe, cancer is one of the predominant causes of mortality and morbidity among older people aged over 65. A diagnosis of cancer can imply a negative impact on the quality of life of the older patients and their families. Despite research examining the impact of cancer on the family, it is unclear what kind of information is available about the types of clinical practice towards older patients with cancer and their families. The aim is to determine the extent, range and variety of research in Europe describing health practices towards families of older patients with cancer and to identify any existing gaps in knowledge. METHODS: Scoping review. RESULTS: A total of 12 articles were included, showing that family interventions are generally based on end-of-life care. Most studies used a qualitative approach and involved different types of family member as participants. Most studies were conducted in the UK. CONCLUSIONS: Review findings revealed limited knowledge about health practices in Europe towards families with an older patient with cancer. This review indicates a need to increase family-focused research that examines health practices that meet the needs of families of older patients with cancer. Seeing cancer as a chronic disease, there is an urgent need for the implementation of family-focused interventions.

Long-term follow-up 3 years after a randomized rehabilitation study among radiated prostate cancer survivors.

PURPOSE: In the Rehabilitation of Prostate Cancer (RePCa) study, the intervention reduced early adverse effects in prostate cancer 6 months after radiotherapy. This 3-year follow-up study assesses late adverse effects, evaluates rehabilitative long-term effects and identifies patients who benefit the most. DESIGN: RePCa was a randomized clinical trial with multidisciplinary rehabilitation (n = 79) or usual care (n = 82). The intervention during the first 6 months consisted of consultations by nurses and physiotherapists focusing on psychosocial support and physical activity, respectively. Here we report the 3-year follow-up. Data consisted of disease-specific quality of life (EPIC-26), general quality of life (SF-12) and pelvic floor strength measured by electromyography. RESULTS: One hundred forty-three patients (92%) responded. The primary outcome urinary irritative sum-score was no longer significantly different between groups. In patients with moderate-severe urinary problems at baseline, we observed a significant long-term effect on the urinary irritative sum-score in favour of the intervention (+ 13.4 points P = .014). More patients had moderate-severe bowel problems in the control group (n = 10; 14%) compared to the intervention group (n = 2; 3%) (P = .016). Pelvic floor strength deteriorated significantly in both groups. CONCLUSION: The short-term rehabilitation was beneficial but of limited benefit in the long term for all patients. A significant and clinically relevant effect was found in irradiated prostate cancer patients with moderate-severe urinary problems at baseline. In both groups, pelvic floor strength was weakened during follow-up. IMPACT FOR CANCER SURVIVORS: Prior research showed patients benefit from early rehabilitation. Identification of patients with moderate-severe urinary problems followed by a focused rehabilitation during the first 6 months after radiotherapy results in long-term improvement. Radiated patients have to be aware of their pelvic floor strength. IMPLICATIONS FOR CANCER SURVIVORS: Patients can be informed that they benefit from early rehabilitation, and they cannot expect larger changes in adverse effects within the first years, but they have to be aware of their pelvic floor strength. Future rehabilitation studies could be applied mainly to patients with assessed rehabilitation needs after radiotherapy and intensified with long-term follow-up.

Nutrition screening and assessment tools for patients with cancer and survivors of cancer: a systematic review protocol.

INTRODUCTION: Nutritional challenges are common consequences of cancer, and they do not only occur in the hospital setting. They are also frequent after completion of treatment, and nutritional interventions in community-based post-treatment rehabilitation services are important. The first step towards initiating any nutritional intervention is to identify the individual in need hereof, but evidence is limited on the applicability of different nutrition screening and assessment tools in the post-treatment rehabilitation services. The aim is to systematically review and identify nutrition screening and assessment tools appropriate for use in patients with cancer and survivors of cancer in hospital or community-based healthcare settings. METHODS AND ANALYSIS: In this systematic review, the electronic databases PubMed, CINAHL Complete and Embase were searched systematically using comprehensive search strategies. Primary searches were carried out in August 2018 with updated searches performed in November 2019. Clinicaltrials.gov and PROSPERO International Prospective Register of Systematic Reviews will be searched for additional relevant studies. Studies will be included if they validate a nutrition screening or assessment tool in adult patients with cancer or survivors of cancer. No restriction on publication date will be applied, and full-text articles in English, Danish, Norwegian and Swedish are eligible for inclusion. Two reviewers will independently conduct screening of search results, study selection, data extraction and quality assessment. Data will be synthesised narratively. ETHICS AND DISSEMINATION: No ethical approval is required. Results will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and published in an international peer-reviewed journal. Furthermore, results will be presented in relevant research and clinical fora to facilitate transfer of results to clinical practice in benefit of patients. PROSPERO REGISTRATION NUMBER: CRD42018096678.

The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial.

BACKGROUND: A randomized controlled pilot trial was conducted to assess if melanoma patients treated with immunotherapy had the number of grade 3 or 4 adverse events during treatment reduced by 50% using a tailored electronic patient-reported outcomes tool in addition to standard toxicity monitoring compared to standard monitoring alone. Secondary endpoints were: if more AEs were reported in the intervention group, if there was a difference between the two groups in the number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity. PATIENTS AND METHODS: Melanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated. Standard care included assessment of AEs by a clinician before each treatment cycle using the Common Terminology Criteria for Adverse Events. In addition, patients randomized to the intervention reported their AEs weekly by an electronic PRO-tool based on the PRO-CTCAE platform. RESULTS: One hundred forty-six melanoma patients were randomized. In this study, we did not detect a difference between the two groups in the number of grade 3 or 4 AEs (P = 0.983), in the overall number of AEs (P = 0.560) or in the time the patients in the two groups experienced grade 2 or higher toxicity (0.516). The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156). CONCLUSION: It has been examined if the number of severe AEs for melanoma patients receiving immunotherapy could be reduced by involving the patients in the reporting of symptoms. The results do not justify the expansion of the pilot study into a regular phase III study with this particular set-up. However, a significant difference in the number of phone contacts was found as patients in the intervention group called more frequently, indicating that their attention to AEs was increased. Even though the use of an electronic PRO tool could not reduce the number of severe AEs in this melanoma population, a positive impact on other endpoints such as QoL, communication, or treatment-planning, cannot be excluded. TRIAL REGISTRATION: Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered.