Self-efficacy of advanced cancer patients for participation in treatment-related decision-making in six European countries: the ACTION study.

PURPOSE: Many patients prefer an active role in making decisions about their care and treatment, but participating in such decision-making is challenging. The aim of this study was to explore whether patient-reported outcomes (quality of life and patient satisfaction), patients' coping strategies, and sociodemographic and clinical characteristics were associated with self-efficacy for participation in decision-making among patients with advanced cancer. METHODS: We used baseline data from the ACTION trial of patients with advanced colorectal or lung cancer from six European countries, including scores on the decision-making participation self-efficacy (DEPS) scale, EORTC QLQ-C15-PAL questionnaire, and the EORTC IN-PATSAT32 questionnaire. Multivariable linear regression analyses were used to examine associations with self-efficacy scores. RESULTS: The sample included 660 patients with a mean age of 66 years (SD 10). Patients had a mean score of 73 (SD 24) for self-efficacy. Problem-focused coping (B 1.41 (95% CI 0.77 to 2.06)), better quality of life (B 2.34 (95% CI 0.89 to 3.80)), and more patient satisfaction (B 7.59 (95% CI 5.61 to 9.56)) were associated with a higher level of self-efficacy. Patients in the Netherlands had a higher level of self-efficacy than patients in Belgium ((B 7.85 (95% CI 2.28 to 13.42)), whereas Italian patients had a lower level ((B -7.50 (95% CI -13.04 to -1.96)) than those in Belgium. CONCLUSION: Coping style, quality of life, and patient satisfaction with care were associated with self-efficacy for participation in decision-making among patients with advanced cancer. These factors are important to consider for healthcare professionals when supporting patients in decision-making processes.

A NEw MOdel of individualized and patient-centered follow-up for women with gynecological cancer (the NEMO study)-protocol and rationale of a randomized clinical trial.

BACKGROUND: Follow-up programs for gynecological cancer patients are currently under revision. There is limited evidence that traditional follow-up and clinical examinations improve survival in an early-stage gynecological setting. Further, traditional follow-up programs fail to accommodate the patient's need for psychosocial and sexual supportive care and to actively involve patients and their relatives in the follow-up process. Individualized programs may replace traditional routine follow-up with fixed intervals and length. Focusing on alarm-symptoms and self-reporting may ensure detection of recurrence while allowing a continuous attention to the patient's well-being and return to daily life. In this study, a nurse-led, individualized, and need-based intervention with a specific focus on patient empowerment is tested against a standard physician-led model primarily focusing on the detection of recurrence. METHODS: The study is designed as a clinical, randomized trial conducted in one of four national onco-gynecological centers in Denmark. Patients with early-stage cervical or endometrial cancer are eligible for inclusion. The intervention group undergoes individualized, nurse-led follow-up supporting patient empowerment including repeated use of electronic patient-reported outcome measures (ePROMs) before each contact as a dialogue support tool. The follow-up contacts are mainly conducted by telephone. All project nurses attended a special training program before project start and are all well-educated and dedicated onco-gynecological nurses. The control group receives standard, physician-led, follow-up without use of ePROMs or specific focus on empowerment. The effect of the intervention is evaluated by questionnaires completed by patients at baseline (3 months after surgery) and 12, 18, and 36 months after surgery. Outcomes include empowerment using the Skill and technique subscale of the HEI-Q questionnaire as the primary outcome while fear of cancer recurrence and health-related quality of life as well as the remaining subscales of the HEI-Q represent secondary outcomes. Data is collected by use of the REDCap technology, which also provides a customized visual support function for the dialogue tool. DISCUSSION: This study will provide new information about follow-up in early-stage gynecological cancer settings and thereby contribute to improvement of future follow-up programs. Importantly, the study will provide knowledge about the impact of specific focus on patient empowerment in follow-up programs and, further, how to facilitate empowerment among patients. TRIAL REGISTRATION: The study is registered at clinicaltrials.gov: ID no. NCT03838861. Registered on 6 February 2019. Protocol version 2, issue date 21 November 2022.

Barriers for Participation in the Danish Colorectal Cancer Screening Program: a Qualitative Study.

PURPOSE: The participation rate in the Danish National Screening Program for Colorectal Cancer is around 60%. Since early detection of cancer through the colorectal cancer screening program (CRCS) reduces mortality rates, it is important to understand why people do not participate. The aim of this study was therefore to examine in depth why some people do not participate in the Danish CRCS program. METHODS: Individual semi-structured interviews were conducted with 18 people who had not participated in the national CRCS program. Data was analyzed using an inductive hermeneutic approach. RESULTS: The analysis uncovered three main themes describing barriers to screening: (a) the accountability for ensuring personal health covered the following sub-themes: (i) when invitation is out of sight it is out of mind, (ii) aversion against own stool sample collection, and (iii) the perceived risk of getting colorectal cancer (CRC); (b) attitudes towards the healthcare system and its organization covered the following sub-themes: (i) positivity towards CRCS, (ii) trust in the healthcare system, (iii) lack of internal communication in the healthcare system, and (iv) wish for involvement of the general practitioner (GP); (c) knowledge about disease and screening covered the following sub-themes: (i) knowledge about CRC and CRCS, (ii) wish for information via new channels, and (iii) CRC is rarely something you talk about. CONCLUSION: Among the informants included in this study, lack of participation in the CRCS program was not due to an active opt-out, as most informants had intentions of participating. The informants thought it would motivate them to participate if their GP would remind them of the screening program.

Development of an advance directive 'communication tool' relevant for patients with advanced cancer in six European countries: Experiences from the ACTION trial.

BACKGROUND: The ACTION trial evaluated the effect of a modified version of the Respecting Choices´ advance care planning programme in patients with advanced cancer in six European countries. For this purpose, an advance directive acceptable for all six ACTION countries to be used for documenting the wishes and preferences of patients and as a communication tool between patients, their caregivers and healthcare staff, was needed. AIM: To describe the development of a multinational cancer specific advance directive, the ´My Preferences form´, which was first based on the 2005 Wisconsin 'Physician Orders of Life Sustaining Treatment´ Form, to be used within the ACTION trial. METHODS: Framework analysis of all textual data produced by members of the international project team during the development of the ACTION advance directives (e.g. drafts, emails, meeting minutes…). SETTING/PARTICIPANTS: ACTION consortium members (N = 28) with input from clinicians from participating hospitals (N = 13) and ´facilitators´ (N = 8) who were going to deliver the intervention. RESULTS: Ten versions of the ACTION advance directive, the ´My Preferences form´, were developed and circulated within the ACTION consortium. Extensive modifications took place; removal, addition, modification of themes and modification of clinical to lay terminology. The result was a thematically comprehensive advance directive to be used as a communication tool across the six European countries within the ACTION trial. CONCLUSION: This article shows the complex task of developing an advance directive suitable for cancer patients from six European countries; a process which required the resolution of several cross cultural differences in law, ethics, philosophy and practice. Our hope is that this paper can contribute to a deeper conceptual understanding of advance directives, their role in supporting decision making among patients approaching the end of life and be an inspiration to others wishing to develop a disease-specific advance directive or a standardised multinational advance directive.

Sexual health and closeness in couples coping with advanced cancer: Results of a multicenter observational study (eQuiPe).

BACKGROUND: Cancer and its treatment can severely affect sexual health. It is unknown how this may relate to the feelings of closeness between patients and their partners. AIM: To assess the association between sexual health and closeness in the relationship in couples coping with advanced cancer. DESIGN: This study was part of a prospective multicentre longitudinal observational cohort study on experienced quality of care and quality of life in patients with advanced cancer and their relatives (eQuiPe). SETTING/PARTICIPANTS: Baseline data regarding sexual health and closeness in people with advanced cancer and their partners. RESULTS: Out of the 566 dyads, 14 were same-sex couples. Especially male partners showed an interest in sex, but more than half of all patients and partners were not sexually active. Approximately one third experienced sexual dysfunction to be a problem but did not seek specialized support (<10%). There was a positive association between own sexual satisfaction and feelings of closeness in the relationship, which was stronger for partners compared to patients (p < 0.001). Sexual satisfaction of the other person was also related to own feelings of closeness (p = 0.003). CONCLUSIONS: Couples coping with advanced cancer clearly face challenges regarding sexual health but are not likely to seek specialized support. When discussing sexual health, it is crucial that health care professionals pay attention to the aspects of sexual health that may contribute to feeling close to each other and suggest specialized care if necessary. TRIAL REGISTRATION: The eQuiPe study is registered as NTR6584 in the Netherlands Trial Register.

Perceptions of person-centred care in two large university hospitals: A cross-sectional survey among healthcare professionals.

BACKGROUND: Patient-centred care (PCC) including collaborative practices is the core component of modern health care. Despite this, it has proven difficult to implement. AIMS: To examine (1) healthcare professionals' (HCPs') perception of whether they perceive a PCC culture, their attitudes towards involving patients in decisions and their experiences of barriers for PCC; and (2) variables that may contribute to explain differences in perceived person-centred culture. METHODS: A questionnaire survey of HCPs from 27 different departments from two university hospitals in Denmark. HCPs were eligible if they held a profession as physician, Registered Nurse, nurse assistant, physiotherapist, occupational therapist, dietician, midwife or psychologist and excluded if they reported not being involved in patient treatment and care. The questionnaire consisted of four items from the Context Assessment Index (CAI). The remaining items were purpose-designed. RESULTS: In total 1140 (24% response rate) HCPs completed the questionnaire and were included in the analyses. Most of the HCPs perceived a culture of PCC (e.g. 91% agreed or agreed to a high degree that patients were provided with opportunities to participate in decisions). Most HCPs also held positive attitudes towards involving patients in decisions. Time and prioritisation from the management were perceived as barriers for PCC, and many HCPs also believed that involving patients in decisions could be difficult for the patients. The HCPs who were least involved in treatment and care, and working in the acute setting or in surgery, were least likely to perceive a PCC culture. HCPs with the longest or shortest educations, and HCPs working primarily with outpatients or with planned inpatients, were most likely to perceive a person-centred culture. CONCLUSION: The HCPs generally perceived a culture of PCC and held positive attitudes towards involving patients in decisions. To further promote PCC, time and prioritisation must be invested at an organisational level.

Promoting health equity in the health-care system: How can we identify potentially vulnerable patients?

BACKGROUND: There is documented social inequality in cancer. The health-care system may contribute to health equity by targeting interventions to potentially vulnerable patients who may be at risk of not receiving optimal treatment and care. AIM: This study aimed to develop and pilot test a tool to identify patients who may need additional support. METHOD: The study took place in a department of palliative medicine and in a team for head and neck cancer within an oncology department. The tool to identify potentially vulnerable patients was developed based on literature reviews and interviews with patients and health-care personnel. It was pilot tested in a six-month period, with subsequent interviews with health-care personnel. RESULTS: In total, 212 consecutive patients referred to the departments were systematically screened with the tool by health-care personnel. Of these, 74 (35%) patients were considered potentially vulnerable. The most frequently reported sign of vulnerability was 'few supportive relations' (47% of the vulnerable patients). Most health-care personnel found it relevant to focus systematically on these patients. However, some were concerned that using the tool could prove to be stigmatising and were critical of attributing the vulnerability to the individual. CONCLUSIONS: Most patients were considered in need of additional support because they lacked a social network or had difficulties communicating with health-care personnel. Applying a tool to identify potentially vulnerable patients was feasible and increased attention to this group of patients. However, the screening procedure was also questioned.

Effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC): study protocol for an international randomized controlled trial.

BACKGROUND: Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress. Psychosocial support and education can reduce distress and prevent avoidable healthcare resource use. To date, we lack knowledge from large-scale studies on which interventions generate positive outcomes for people with cancer and their informal caregivers' quality of life. This protocol describes the DIAdIC study that will evaluate the effectiveness of two psychosocial and educational interventions aimed at improving patient-family caregiver dyads' emotional functioning and self-efficacy. METHODS: We will conduct an international multicenter three-arm randomized controlled trial in Belgium, Denmark, Ireland, Italy, The Netherlands, and the United Kingdom. In each country, 156 dyads (936 in total) of people with advanced cancer and their family caregiver will be randomized to one of the study arms: 1) a nurse-led face-to-face intervention (FOCUS+), 2) a web-based intervention (iFOCUS) or 3) a control group (care as usual). The two interventions offer tailored psychoeducational support for patient-family caregiver dyads. The nurse-led face-to-face intervention consists of two home visits and one online video session and the web-based intervention is completed independently by the patient-family caregiver dyad in four online sessions. The interventions are based on the FOCUS intervention, developed in the USA, that addresses five core components: family involvement, optimistic outlook, coping effectiveness, uncertainty reduction, and symptom management. The FOCUS intervention will be adapted to the European context. The primary outcomes are emotional functioning and self-efficacy of the patient and the family caregiver, respectively. The secondary outcomes are quality of life, benefits of illness, coping, dyadic communication, and ways of giving support of the patient and family caregiver. DISCUSSION: DIAdIC aims to develop cost-effective interventions that integrate principles of early palliative care into standard care. The cross-country setup in six European countries allows for comparison of effectiveness of the interventions in different healthcare systems across Europe. By focusing on empowerment of the person with cancer and their family caregiver, the results of this RCT can contribute to the search for cost-effective novel interventions that can relieve constraints on professional healthcare. TRIAL REGISTRATION: Registration on ClinicalTrials.gov on 12/11/2020, identifier NCT04626349 . DATE AND VERSION IDENTIFIER: 20211209_DIAdIC_Protocol_Article.

Early specialised palliative care: interventions, symptoms, problems.

BACKGROUND: Few studies have investigated the content of interventions provided in early specialised palliative care (SPC). OBJECTIVES: To characterise the content of interventions delivered in early SPC in the Danish Palliative Care Trial (DanPaCT), a multicentre trial with six participating sites. METHODS: A retrospective qualitative and quantitative study coding all new interventions initiated by the palliative teams and documented in the medical records during the 8-week study period of DanPaCT. Interventions were categorised according to (a) symptom/problem prompting the intervention, (b) type of intervention and (c) professional(s) providing the intervention. RESULTS: In total, 145 patients were randomised to the SPC teams. According to the medical records, patients received a median of 3.5 (range 0-22) new interventions in the 8-week intervention-period from the palliative teams. For 24 (18%) of the patients there was no documented interventions in the medical records. The most frequent symptom/problems treated were pain, (100 interventions; 20% of interventions given) and impaired physical function (62; 13% of interventions given). The most frequent type of intervention was pharmacological (232; 42% of interventions given). CONCLUSIONS: This is one of the first studies to meticulously investigate the content of interventions documented in the medical records for patients receiving early SPC. Diverse symptoms were treated with many different interventions. However, a relatively low number of interventions were documented. This may explain the lack of effect in DanPaCT but also questions whether all interventions were adequately documented TRIAL REGISTRATION NUMBER: NCT01348048.

Crossing borders: a systematic review identifying potential mechanisms of intergenerational trauma transmission in asylum-seeking and refugee families.

Background: As displacement and forced migration continue to exhibit global growth trends, new and surviving generations of children are being born and spending their formative years in host countries. Refugee children who have not been exposed to traumatic events may still be at risk for adverse developmental and mental health outcomes via intergenerational trauma transmission. Objective: To identify and synthesize potential mechanisms of intergenerational trauma transmission in forcibly displaced families where parents have experienced direct war-related trauma exposure, but children have no history of direct trauma exposure. Methods: PRISMA systematic review guidelines were adhered to. Searches were conducted across seven major databases and included quantitative, qualitative and mixed methods literature from 1945 to 2019. The search resulted in 752 citations and 8 studies (n = 1,684) met review inclusion criteria. Results: Findings suggest that parental trauma exposure and trauma sequelae indirectly affect child well-being via potential mechanisms of insecure attachment; maladaptive parenting styles; diminished parental emotional availability; decreased family functioning; accumulation of family stressors; dysfunctional intra-family communication styles and severity of parental symptomology. Conclusion: Further research is needed to assess independent intergenerational effects and mechanisms of trauma transmission in this population.

Antecedentes: A medida que el desplazamiento y la migración forzada exhiben de manera continua tendencias de crecimiento global, las nuevas y sobrevivientes generaciones de niños nacen y pasan sus años de formación en los países de acogida. Los niños refugiados que no han estado expuestos a eventos traumáticos aún pueden estar en riesgo de consecuencias adversas para el desarrollo y la salud mental a través de la transmisión intergeneracional del trauma.Objetivo: Identificar y sintetizar mecanismos potenciales de transmisión intergeneracional de traumas en familias desplazadas por la fuerza donde los padres han experimentado una exposición directa al trauma relacionada con la guerra, pero los niños no tienen antecedentes de exposición directa al trauma.Métodos: Se siguieron las pautas de revisión sistemática PRISMA. Las búsquedas se realizaron en siete bases de datos principales e incluyeron literatura sobre métodos cuantitativos, cualitativos y mixtos desde 1945 al 2019. La búsqueda resultó en 752 citas y 8 estudios (n = 1.684) cumplieron con los criterios de inclusión de la revisión.Resultados: Los resultados sugieren que la exposición al trauma parental y las secuelas del trauma afectan indirectamente el bienestar del niño a través de mecanismos de apego inseguro; estilos de parentalidad maladaptativos; disminución de la disponibilidad emocional parental; disminución del funcionamiento familiar; acumulación de estresores familiares; estilos de comunicación intrafamiliar disfuncionales y gravedad de la sintomatología parental.Conclusión: existe una clara necesidad de apoyar a los padres y a sus hijos que han estado expuestos a traumas de guerra. Se necesita más investigación para evaluar los efectos intergeneracionales independientes de la transmisión del trauma en esta población.

Development and content validation of a questionnaire measuring patient empowerment in cancer follow-up.

PURPOSE: The aim of this study was to develop and ensure the content validity of a new patient-reported outcome measure, the Cancer Patient Empowerment Questionnaire (CPEQ), to measure the level of, desire for, and enablement of empowerment among cancer patients in follow-up. METHODS: An iterative process based on: (i) empowerment theories by Zimmerman and Tengland, (ii) a systematic review of questionnaires measuring empowerment or related concepts among cancer patients, (iii) qualitative data from 18 semi-structured interviews with Danish cancer patients in follow-up, (iv) input from a group of eight cancer patients involved as co-researchers and from an expert steering group, and (v) cognitive interviews with 15 cancer patients in follow-up. RESULTS: The items for the CPEQ were developed and revised and 12 versions of the questionnaire were evaluated. The final version consists of 67 items, covering three different dimensions of empowerment: (A) empowerment outcomes consisting of three components: (A1) the intrapersonal-, (A2) interactional-, and (A3) behavioral component, (B) empowerment facilitators (enablement), and (C) the value of empowerment. CONCLUSIONS: This study documents the theoretical and empirical basis for the development of the CPEQ and its content validity. The CPEQ provides a tool for researchers to assess the level of, desire for, and enablement of empowerment among cancer patients. The next steps will be to use the CPEQ in a nationwide study of empowerment in cancer follow-up and subsequently shorten the CPEQ based on psychometric methods in order to make it more relevant in clinical studies.

There's Nothing Broken. You've Had a Whiplash, That's It: A Qualitative Study of Comorbid Posttraumatic Stress Disorder and Whiplash Associated Disorders.

BACKGROUND: Posttraumatic stress disorder (PTSD) symptoms are common in chronic Whiplash associated disorders (WAD) and have been found to be associated with higher levels of pain and disability. Theoretical frameworks have suggested that PTSD and pain not only coexist, but also mutually maintain one another. Although the comorbidity has been subject to increasing quantitative research, patients' experiences of the comorbidity and symptom interaction remain largely uninvestigated using qualitative methods. OBJECTIVE: The present study set out to explore the potential relationship of PTSD and pain in people with WAD and properly assessed PTSD after motor vehicle accidents. METHODS: A qualitative explorative study of eight individual face-to-face semistructured interviews were conducted. Interviews were recorded and transcribed verbatim and analyzed using framework analysis. RESULTS: Through the analysis, we developed three overarching themes. The first theme illustrated the complex and burdensome comorbidity with overlapping and transdiagnostic symptoms, whereas the second theme highlighted how several circumstances, some related to the health care system, could extend and amplify the traumatic response. The final theme illustrated symptom associations and interactions, particularly between pain and PTSD, both supporting and rejecting parts of the mutual maintenance framework. CONCLUSIONS: These findings underlined the great complexity and variability of the comorbidity and the traumatic event, but also emphasized how experiences of psyche and soma seem closely connected in these patients. The results provide support for the importance of thorough assessment by multidisciplinary teams, minimizing distress post-injury, and a critical approach to the idea of mutual maintenance between pain and PTSD.

Exploratory analyses of the Danish Palliative Care Trial (DanPaCT): a randomized trial of early specialized palliative care plus standard care versus standard care in advanced cancer patients.

BACKGROUND: Early and integrated specialized palliative care is often recommended but has still only been investigated in relatively few randomized clinical trials. OBJECTIVE: To investigate the effect of early specialized palliative care plus standard care versus standard care on the explorative outcomes in the Danish Palliative Care Trial (DanPaCT). METHODS: We conducted a randomized multicentre, parallel-group clinical trial. Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Outcomes were estimated as the differences between the intervention and the control groups in the change from baseline to the weighted mean of the 3- and 8-week follow-ups measured as areas under the curve. RESULTS: In total, 145 patients were randomized to early specialized palliative care plus standard care versus 152 to standard care only. Early specialized palliative care had no significant effect on any of the symptoms or problems. Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05). CONCLUSION: In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems. However, patients in the intervention group seemed more satisfied with the health care received than those in the standard care group. TRIAL REGISTRATION: NCT01348048.

Advance care planning for patients and their relatives.

BACKGROUND: Advance care planning (ACP) has been suggested to improve the quality of life (QoL) and mental wellbeing in severely ill patients and their relatives. AIM: To investigate the effects of ACP among patients with lung, heart and cancer diseases with an estimated life-span of up to 12 months. METHODS: Patients and relatives were randomised into two groups: one receiving usual care and one receiving ACP and usual care. Themes from the ACP discussion were documented in patients' electronic medical file. Participants completed self-reported questionnaires four to five weeks after randomisation. FINDINGS: In total, 141 patients and 127 relatives participated. No significant differences were found according to outcomes. However, patients with non-malignant diseases had the highest level of anxiety and depression; these patients seemed to benefit the most from ACP, though not showing statistically significant results. CONCLUSION: No significant effects of ACP among patients with lung, heart, and cancer diseases and their relatives regarding HRQoL, anxiety, depression, and satisfaction with healthcare were found.

Prevalence and possible predictors of sexual dysfunction and self-reported needs related to the sexual life of advanced cancer patients.

Background: Sexual dysfunction and problems are common late effects after treatment of cancer. However, little is known about the prevalence and risk factors for sexual dysfunction in patients with advanced cancer. The aim of this study was to investigate the prevalence and predictors of sexual problems and needs in a large sample of Danish patients with advanced cancer. Methodology: The data derived from a representative cross-sectional study of patients with advanced cancer. Patients who had been in contact with 1 of 54 hospital departments were invited to fill out a questionnaire on symptoms and problems. Five items asked about sexuality. Ordinal logistic regression was used to identify variables associated with sexual functioning in explorative analyses. Results: A total of 1,447 patients completed the questionnaire and of those, 961 patients (66%) completed the sexuality items. More than half of the patients (60%) had not been sexually active within the previous month, despite a high prevalence of desire for sexual intimacy (62%). More than half of the patients (57%) experienced that their physical condition or treatment had impaired their sex life. Of those, 52% experienced an unmet need for help with sexual problems from the health care system. Older patients were less likely to report sexual problems than younger patients. Having prostate or gynecologic cancer was associated with the feeling that one's sexual life was negatively influenced. Conclusion: Sexual problems are common among patients with advanced cancer and should be addressed by the health care system.

Nausea in advanced cancer: relationships between intensity, burden, and the need for help.

PURPOSE: This study aimed at expanding the knowledge of nausea in patients with advanced cancer by elucidating (a) the prevalences of patients having nausea, experiencing nausea as a problem, and having a need for help with their nausea, respectively, (b) determining variables associated with nausea, and (c) investigating the relation between nausea and the need for help regarding nausea. METHODS: In 2004-2006, the EORTC QLQ-C30 and the Three-Levels-of-Needs Questionnaire (3LNQ) were mailed to 2364 patients with advanced cancer who had been in contact with one of the 54 hospital departments within the past year. Further information was collected from medical records. RESULTS: Patient-response rate was 61%. Twenty-two percent reported having had some degree of nausea within the past week, with a mean nausea score of 10.4 and a two-item combined nausea and vomiting score of 7.5 (0-100, 100 = "very much"). Factors associated with nausea on the multivariate level were contact type (inpatient/outpatient) and treatment status (receiving ongoing oncologic treatment yes/no). "Nausea intensity" and "nausea problem burden" showed acceptable abilities to distinguish between patients having or not having an unmet need for help regarding nausea with areas under the curve (AUCs) of 0.81 and 0.82, respectively. CONCLUSIONS: Around one in four patients with advanced cancer reported nausea within the past week, highest in patients who were inpatients or undergoing active oncologic treatment. Almost all patients reporting nausea on the EORTC QLQ-C30 experienced this to be a problem, and the 3LNQ can therefore be restricted to cases where additional details are needed.

The 'Cancer Home-Life Intervention': A randomised controlled trial evaluating the efficacy of an occupational therapy-based intervention in people with advanced cancer.

BACKGROUND: People with advanced cancer face difficulties with their everyday activities at home that may reduce their health-related quality of life. To address these difficulties, we developed the 'Cancer Home-Life Intervention'. AIM: To evaluate the efficacy of the 'Cancer Home Life-Intervention' compared with usual care with regard to patients' performance of, and participation in, everyday activities, and their health-related quality of life. DESIGN AND INTERVENTION: A randomised controlled trial ( ClinicalTrials.gov NCT02356627). The 'Cancer Home-Life Intervention' is a brief, tailored, occupational therapy-based and adaptive programme for people with advanced cancer targeting the performance of their prioritised everyday activities. SETTING/PARTICIPANTS: Home-living adults diagnosed with advanced cancer experiencing functional limitations were recruited from two Danish hospitals. They were assessed at baseline, and at 6 and 12 weeks of follow-up. The primary outcome was activities of daily living motor ability. Secondary outcomes were activities of daily living process ability, difficulty performing prioritised everyday activities, participation restrictions and health-related quality of life. RESULTS: A total of 242 participants were randomised either to the intervention group ( n = 121) or the control group ( n = 121). No effect was found on the primary outcome (between-group mean change: -0.04 logits (95% confidence interval: -0.23 to 0.15); p = 0.69). Nor was any effect on the secondary outcomes observed. CONCLUSION: In most cases, the 'Cancer Home-Life Intervention' was delivered through only one home visit and one follow-up telephone contact, which not was effective in maintaining or improving participants' everyday activities and health-related quality of life. Future research should pay even more attention to intervention development and feasibility testing.

Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial.

BACKGROUND: Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal. AIM: To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments. SETTING/PARTICIPANTS: The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient's primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0-100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival. RESULTS: Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (-4.9 points (95% confidence interval -11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect. CONCLUSION: We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.

[Care and treatment can be planned in advance with advance care planning].

Advance care planning (ACP) is a discussion between an incurably ill patient, a healthcare professional and if possible, a relative about preferences for end-of-life care, and ACP may improve the communication in this situation. However, in the Danish healthcare system there is no formalized and systematically used standard procedure for discussions with patients about their knowledge of their treatment options, values and preferences. In this article we review the concept of ACP, including definition, experiences from abroad and the status of ACP in Denmark.