Vaginal CO2 laser therapy for genitourinary syndrome in breast cancer survivors-VagLaser study protocol: a randomized blinded, placebo-controlled trial.

BACKGROUND: Vaginal CO2 laser therapy is a new treatment option for genitourinary syndrome of menopause. Its potential is particularly interesting in breast cancer survivors, where existing treatment options often are insufficient as hormonal treatment is problematic in these women. The objective of this study is to investigate the effectiveness of vaginal laser treatment for alleviation of genitourinary syndrome of menopause in breast cancer survivors treated with adjuvant endocrine therapy. The secondary objective is to explore the importance of repeated vaginal laser treatment and the long-term effects in this patient population. METHODS: VagLaser consist of three sub-studies; a dose response study, a randomized, participant blinded, placebo-controlled study and a follow-up study. All studies include breast cancer survivors in adjuvant endocrine therapy, and are conducted at the Department of Obstetrics and Gynecology, Randers Regional Hospital, Denmark. The first participant was recruited on 16th of February 2023. Primary outcome is vaginal dryness. Secondary subjective outcomes are vaginal pain, itching, soreness, urinary symptoms and sexual function. Secondary objective outcomes are change in vaginal histology (punch biopsy), change in vaginal and urine microbiota, and change in vaginal pH. DISCUSSION: More randomized controlled trials, with longer follow-up to explore the optimal treatment regimen and the number of repeat vaginal laser treatments for alleviation the symptoms of genitourinary syndrome of menopause in breast cancer survivors treated with endocrine adjuvant therapy, are needed. This study will be the first to investigate change in vaginal and urine microbiota during vaginal laser therapy in breast cancer survivors. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06007027 (registered 22 August, 2023). PROTOCOL VERSION: Version 1, Date 13.11.2023.

Prognosis of breast cancer patients with brain metastasis treated with radiotherapy.

BACKGROUND: Life expectancy for patients diagnosed with metastatic breast cancer (BC) has improved in recent years, especially due to better systemic treatment. This has led to an increased incidence of brain metastases (BM), and BC is now the leading cause of BM in women. Treatment of BM primarily consists of surgery and/or radiotherapy. We aimed to investigate survival time and prognostic factors for BC patients treated with radiotherapy for BM. MATERIAL & METHODS: During the period 1st of January 2015 to 1st of June 2020, 144 consecutive BC patients treated for BM from one centre were retrospectively analyzed. The patients were either diagnosed with BM as the first metastatic lesion, or developed BM during palliative therapy for distant non-brain metastasis. The study was approved by the Central Denmark Region. RESULTS: Median age at BM diagnosis was 66 years, and 90% of the patients already had extracranial metastatic disease at BM diagnosis. Median overall survival after diagnosis of BM was 6.1 months. Short survival was observed for patients with poor performance status, leptomeningeal metastasis or more than three solid BM. Several of these factors were overrepresented in patients with estrogen receptor-positive (ER+) tumours who had poorer survival than patients with different receptor status. CONCLUSION: The number of metastatic BC patients developing BM is high, and survival following local treatment remains poor. Several prognostic factors appear to influence survival after radiotherapy. Treatment of BC patients with BM should be individualized according to performance status, leptomeningeal disease, number of BM, and receptor status of the disease.

Dose modifications of ribociclib and endocrine therapy for treatment of ER+ HER2- metastatic breast cancer.

PURPOSE: Treatment for estrogen receptor positive (ER+), human epidermal receptor 2 negative (HER2-) metastatic breast cancer (MBC) has improved with the approval of CDK 4/6 inhibitors. Clinical trials with the CDK4/6 inhibitor ribociclib, suggest that 35% to 57.5% of the patients require a dose reduction during ribociclib treatment. Data on the possible consequences of dose reduction concerning efficacy is needed. METHODS: A retrospective cohort study on patients with ER+ HER2- MBC from three Danish oncology departments. Data on tolerability and progression-free survival were collected from electronic health records. RESULTS: One hundred and twenty-eight patients with ER+ HER2- MBC who initiated ribociclib treatment between 1st of January 2018 to 31st of March 2020 were included in our analysis. Of these patients, 48.4% required one or more dose reductions. Overall median PFS was 19.2 months (CI-95% 14.3-NR). Patients with one or more dose reductions did not have decreased median PFS (19.2 months, CI-95% 14.3-NR compared to 12.2 months, CI-95% 7.3-NR, p = 0.078). Frequency of adverse events were as previously reported, with grade III and IV neutropenia occurring in 45.3% and 7% of patients, respectively. Patients treated with fulvestrant versus an aromatase inhibitor and patients with lymph node involvement at baseline had lower odds of requiring a dose reduction (ORa = 0.30, CI-95% 0.12-0.73 & ORa = 0.41, CI-95% 0.18-0.89, respectively). CONCLUSION: Our results indicate that dose reduction of ribociclib is safe and do not compromise the efficacy of the treatment. Furthermore, the study supports translation of results from the MONALEESA trials to patients treated in real-world clinical settings.

Comparison of contrast-enhanced CT, dual-layer detector spectral CT, and whole-body MRI in suspected metastatic breast cancer: a prospective diagnostic accuracy study.

OBJECTIVES: To compare diagnostic accuracy of contrast-enhanced CT, dual-layer detector spectral CT (DL-CT), and whole-body MRI (WB-MRI) for diagnosing metastatic breast cancer. METHODS: One hundred eighty-two biopsy-verified breast cancer patients suspected of metastatic disease prospectively underwent contrast-enhanced DL-CT and WB-MRI. Two radiologists read the CT examinations with and without spectral data in consensus with 3-month washout between readings. Two other radiologists read the WB-MRI examinations in consensus. Lymph nodes, visceral lesions, and bone lesions were assessed. Readers were blinded to other test results. Reference standard was histopathology, previous or follow-up imaging, and clinical follow-up. RESULTS: Per-lesion AUC was 0.80, 0.84, and 0.82 (CT, DL-CT, and WB-MRI, respectively). DL-CT showed significantly higher AUC than CT (p = 0.001) and WB-MRI (p = 0.02). Sensitivity and specificity of CT, DL-CT, and WB-MRI were 0.66 and 0.94, 0.75 and 0.95, and 0.65 and 0.98, respectively. DL-CT significantly improved sensitivity compared to CT (p < 0.0001) and WB-MRI (p = 0.002). Per-patient AUC was 0.85, 0.90, and 0.92 (CT, DL-CT, and WB-MRI, respectively). DL-CT and WB-MRI had significantly higher AUC than CT (p = 0.04 and p = 0.03). DL-CT significantly increased sensitivity compared to CT (0.89 vs. 0.79, p = 0.04). WB-MRI had significantly higher specificity than CT (0.84 vs. 0.96, p = 0.001) and DL-CT (0.87 vs. 0.96, p = 0.02). CONCLUSIONS: DL-CT showed significantly higher per-lesion diagnostic performance and sensitivity than CT and WB-MRI. On a per-patient basis, DL-CT and WB-MRI had equal diagnostic performance superior to CT. KEY POINTS: • Spectral CT has higher diagnostic performance for diagnosing breast cancer metastases compared to conventional CT and whole-body MRI on a per-lesion basis. • Spectral CT and whole-body MRI are superior to conventional CT for diagnosing patients with metastatic breast cancer. • Whole-body MRI is superior to conventional CT and spectral CT for diagnosing bone metastases.

The majority of Danish breast cancer survivors on adjuvant endocrine therapy have clinically relevant sexual dysfunction: a cross-sectional study.

BACKGROUND: Impairments in sexual function are common among breast cancer survivors (BCSs), particularly in BCSs receiving adjuvant endocrine therapy (AET). Whether these impairments cause distress, thus qualifying for a more clinically relevant diagnosis of sexual dysfunction (SD), is inadequately described among BCSs and represents an important research gap. Hence, the primary aim of this study was to estimate the prevalence of clinically relevant SD, in this context: impairments with associated distress, and to identify factors associated with SD among BCSs on AET. Secondly, to explore the extent of distress caused by specific impairments in sexual function. MATERIALS AND METHODS: In this cross-sectional study of BCSs on adjuvant treatment with endocrine therapy for at least three months, participants completed an online survey comprising standardized measures of sexual and psychosocial function. Female Sexual Function Index (FSFI) and Sexual Complaint Screener - Women (SCS-W) were used to asses clinically relevant SD. Multiple regression analyses were performed to identify factors significantly associated with SD. RESULTS: In total, 333 BCSs with a mean age of 58.7 years were included in the study, of whom 227 were sexually active. Among sexually active BCSs, 134 (59%) met the criteria for having clinically relevant SD, of whom 78 (58%) perceived cancer treatment as the primary reason for their sexual problems. Factors associated with SD included vaginal dryness (adjusted OR= 2.25, 95% CI: 1.52-3.34, p < .01) and psychological well-being (adjusted OR= 1.11, 95% CI: 1.03-1.18, p < .01). Age was not related to neither prevalence of SD nor the level of distress caused by any impairment, with exception of low sexual desire. Pain in relation to intercourse was the most distressing impairment. CONCLUSION: SD was highly prevalent among sexually active BCSs on AET. Sexual health is important to address independent of the woman's age.

Municipal return to work management in cancer survivors: a controlled intervention study.

INTRODUCTION: Resuming work during or after cancer treatment has become an important target in cancer rehabilitation. PURPOSE: The aim was in a controlled trial to study the return to work (RTW) effect of an early, individually tailored vocational rehabilitation intervention targeted to improve readiness for RTW in cancer survivors. MATERIAL AND METHODS: Participants diagnosed with breast, cervix, ovary, testicular, colon-rectal, and head-and-neck cancers as well as being employed were allocated to a vocational rehabilitation intervention provided by municipal social workers (n = 83) or to usual municipal RTW management (n = 264). The intervention contained three elements: motivational communication inspired by Acceptance and Commitment Therapy by which RTW barriers were addressed, municipal cancer rehabilitation and finally employer and workplace contact. RTW effect was assessed as relative cumulative incidence proportions (RCIP) in the control and intervention group within 52 weeks of follow-up, estimated from the week where treatment ended at the hospital. RCIP was interpreted and reported as relative risk (RR) with 95% confidence intervals (CI) adjusted for gender, age cancer diagnosis, education, comorbidity, and sick leave weeks. RESULTS: Across cancer diagnoses 69 (83.1%) and 215 (81.4%) returned to work in the intervention and control group, respectively. No statistical effect was seen (RR 1.08 (95% CI 0.98-1.19)). Repeating the analyses solely for participants with breast cancer (n = 290) showed a significant effect of the intervention (RR 1.12 (95% CI 1.01-1.23)). CONCLUSION: More than 80% returned to work in both groups. However, no statistical difference in RTW effect was seen across cancer diagnoses within one year from being exposed to an early, individually tailored vocational rehabilitation intervention compared with usual municipal RTW management. TRIAL REGISTRATION NUMBER: ISRCTN50753764.

Key metabolic parameters change significantly in early breast cancer survivors: an explorative PILOT study.

BACKGROUND: With increasing number of breast cancer survivors, more attention is drawn to long-term consequences of curative cancer treatment. Adjuvant treatment of breast cancer patients is associated with several unfavorable medical conditions, including dyslipidemia, insulin resistance, and obesity, potentially leading to cardiovascular disease and/or the metabolic syndrome. The aim of this explorative study is to investigate metabolic side effects of adjuvant treatment in breast cancer patients. METHODS: A cohort of 13 premenopausal and 20 postmenopausal women with early stage breast cancer were extensively examined prior to, immediately after and 1 year after ended adjuvant chemotherapy and compared with healthy controls (N = 36) matched by age and menopausal status. Repeated examinations included: anthropometric measures, DEXA scans, 24-h blood pressure measurements, and blood samples [high sensitivity CRP, lipid profile and glucose metabolism, including homeostatic model assessment (HOMA)]. RESULTS: At baseline, breast cancer patients were similar to healthy controls regarding all measures. From baseline to 1-year post-treatment specific components of the metabolic syndrome increased significantly in premenopausal breast cancer patients; body fat (P = 0.01), triglycerides (P = 0.03), waist circumference (P = 0.008) and diastolic blood pressure (P = 0.04). In postmenopausal patients, waist circumference also increased significantly (P = 0.03), and High density lipoprotein (HDL) cholesterol decreased significantly (P = 0.05). CONCLUSIONS: Specific components of the metabolic syndrome changed significantly during chemotherapy in early stage breast cancer patients. After 1 year, several key parameters remained pathologically changed. Premenopausal breast cancer patients seemed to be especially prone to develop these unfavorable changes. Trial registration ClinicalTrial.gov, registration number NCT02652975. Registered 15 December 2015-Retrospectively registered, https://clinicaltrials.gov/ .

Development of a Cancer Self-management Education Programme for Women with Breast Cancer at the End of Primary Treatment.

Breast cancer survivors have specific healthcare needs. As a result of their disease and treatment, they have to adapt to different physical and psychosocial late effects. Unfortunately, several studies have documented insufficiency in the survivorship healthcare system. The aim of this paper was to describe the process of development and testing of a novel Cancer Self-management Education programme (CSME programme) to improve patient-reported self-management and self-efficacy for patients with breast cancer who were at the end of primary treatment. The development of the educational programme was inspired by the Plan-Do-Study-Act (PDSA) circle and based on person-centred principles. It was conducted at a Danish university hospital. Nine oncology healthcare providers, two external experts in patient education and five patients were involved in the development and testing of the education programme. Implementation of dialogue-based tools was used as an educational learning instrument in the SCME programme. The PDSA approach to the development of the CSME programme resulted in a person-centred programme that could improve self-management and self-efficacy in the survivorship phase of patients with breast cancer.

Propensity for paying home visits among general practitioners and the associations with cancer patients' place of care and death: a register-based cohort study.

BACKGROUND: Previous studies of associations between home visits by general practitioners and end-of-life care for cancer patients have been subject to confounding. AIM: To analyse associations between general practitioners' propensity to pay home visits and the likelihood of hospitalisation and dying out of hospital among their cancer patients. DESIGN: A national register cohort study with an ecological exposure. Standardised incidence rates of general practitioner home visits were calculated as a measure for propensity. Practices were grouped into propensity quartiles. Associations between propensity groups and end-of-life outcomes for cancer patients aged 40 or above were calculated. SETTING/PARTICIPANTS: Danish general practitioners and citizens aged 40 or above were included from 2003 to 2012. RESULTS: We included 2670 practices with 2,518,091 listed patients (18,364,679 person-years); of whom 116,677 died from cancer. General practitioners were grouped into quartiles based on the general practitioners' propensity to pay home visits, which varied 6.6-fold between quartiles. Cancer patients in Group 4 (highest propensity) were less hospitalised than patients in Group 1 (lowest propensity): odds ratio: 1.13 (95% confidence interval: 1.08; 1.17) for ⩽3 bed-days and odds ratio: 0.95 (0.91-0.99) for ⩾20 bed-days. Group 4 patients were more likely to die out of hospital (odds ratio: 1.20 (1.16; 1.24)) than Group 1 patients. CONCLUSION: We found a dose-response-like association between general practitioners' higher propensity to pay home visit and their patients' likelihood of less end-of-life hospitalisation and more often dying out of hospital.

Development, modelling, and pilot testing of a complex intervention to support end-of-life care provided by Danish general practitioners.

BACKGROUND: Most patients in end-of-life with life-threatening diseases prefer to be cared for and die at home. Nevertheless, the majority die in hospitals. GPs have a pivotal role in providing end-of-life care at patients' home, and their involvement in the palliative trajectory enhances the patient's possibility to stay at home. The aim of this study was to develop and pilot-test an intervention consisting of continuing medical education (CME) and electronic decision support (EDS) to support end-of-life care in general practice. METHODS: We developed an intervention in line with the first phases of the guidelines for complex interventions drawn up by the Medical Research Council. Phase 1 involved the development of the intervention including identification of key barriers to provision of end-of-life care for GPs and of facilitators of change. Furthermore the actual modelling of two components: CME meeting and EDS. Phase 2 focused on pilot-testing and intervention assessment by process evaluation. RESULTS: In phase 1 lack of identification of patients at the end of life and limited palliative knowledge among GPs were identified as barriers. The CME meeting and the EDS were developed. The CME meeting was a four-hour educational meeting performed by GPs and specialists in palliative care. The EDS consisted of two parts: a pop-up window for each patient with palliative needs and a list of all patients with palliative needs in the practice. The pilot testing in phase 2 showed that the CME meeting was performed as intended and 120 (14%) of the GPs in the region attended. The EDS was integrated in existing electronic records but was shut down early for external reasons; 50 (5%) GPs signed up. The pilot-testing demonstrated a need to strengthen the implementation as attending rate was low in the current set-up. CONCLUSION: We developed a complex intervention to support GPs in providing end-of-life care. The pilot-test showed general acceptance of the CME meetings. The EDS was shut down early and needs further evaluation before examining the whole intervention in a larger study, where evaluation could be based on patient-related outcomes and impact on end-of-life care. TRIAL REGISTRATION: Clinicaltrials.gov ( NCT02050256 ) January 30, 2014.

Asking terminally ill patients about their preferences concerning place of care and death.

BACKGROUND: Asking patients with palliative care needs about their end-of-life (EoL) preferences is widely acknowledged as an important aspect of EoL care. However, the issue of how to ask patients these questions has not been fully explored. Most prior studies in this area do not differentiate between patients' pragmatic preferences and ideal preferences, and between preferences concerning place of care (PoC) and place of death (PoD). AIM: The aim of this study was to examine possible differences between pragmatic and ideal preferences of terminally ill patients, as well as differences between asking patients about preferences concerning PoC and PoD. METHODS: Structured interviews were performed with terminally ill cancer patients at inclusion and a follow-up questionnaire was completed 1 month later. Answers were compared using kappa (k) statistics and Pearson's c2-test. RESULTS: Among 96 cancer patients, agreement between pragmatic and ideal preferences was statistically significantly different (p=<0.001). Agreement between preferences for PoC and PoD was high (k:0.76-0.85). CONCLUSION: Differences exist between pragmatic and ideal EoL preferences, whereas preferences for PoC and PoD were found to be similar. These findings highlight the importance of the phrasing of questions when uncovering patients' preferences for EoL care.

Women with breast cancer report substantially more disease- and treatment-related side or late effects than registered by clinical oncologists: a cross-sectional study of a standard follow-up program in an oncological department.

BACKGROUND: Follow-up after breast cancer treatment is standard due to the risk of development of new primary cancers and recurrent disease. The aim of the present study was to evaluate a standard follow-up program in an oncological department by assessing: (1) Symptoms or signs of new primary cancer or recurrent disease, (2) Disease- and treatment-related physical and psychosocial side or late effects, and (3) relevant actions by oncology staff. MATERIALS AND METHODS: In a cross-sectional study, 194 women who came for follow-up visit after treatment for primary surgery were included. The clinical oncologists registered symptoms and signs of recurrent disease or new primary cancer. Side or late effects were both assessed by patient and the clinical oncologists. RESULTS: Loco-regional or distant signs of recurrent disease were suspected in eight (5%) patients. Further examinations revealed no disease recurrence. Most patients (93%) reported some degree of side or late effects. Statistically significant more side or late effects were reported by the women (average: 6.9) than registered by the clinical oncologists (average: 2.4), p < 0.001. The three most often patient-reported side or late effects were hot flushes (35%), fatigue (32%), and sleep disturbance (31%). CONCLUSION: None of the scheduled or additional visits resulted in detection of recurrent disease. Furthermore, the majority of patients reported side or late effects. Statistically significant more women reported side or late effects than registered by the clinical oncologists. This suggests the need for rethinking of the follow-up programs with more emphasis upon side or late effects of the treatment.

Prognostic factors in early breast cancer associated with body mass index, physical functioning, physical activity, and comorbidity: data from a nationwide Danish cohort.

PURPOSE: To explore the associations between lifestyle-related factors and tumor-related prognostic factors in women treated for primary breast cancer, and to detect possible differences between the associations in pre- and postmenopausal women. METHODS: Associations between tumor-related prognostic factors, including the composite endpoint risk of recurrence (RoR), body mass index (BMI), comorbidity (Charlson comorbidity index), basic physical functioning (SF-36), physical activity, smoking, and alcohol consumption were examined with binary logistic regression analysis in a national cohort of 4917 women treated for primary breast cancer. In addition, statistical interactions between predictors and menopausal status were assessed in order to determine if their strength differed significantly as a function of menopausal status. RESULTS: Higher BMI, reduced physical function, reduced physical activity, and greater alcohol consumption were all statistically significantly associated with two or more tumor-related factors indicating a poorer prognosis. Interaction analysis revealed that BMI was significantly stronger associated with RoR among premenopausal women than among postmenopausal women (interaction ip = 0.048). Similarly, a significant association between RoR and physical function was only seen in the premenopausal population (ip = 0.008). This pattern was also seen between RoR and daily alcohol consumption, which only reached statistical significance in the total population and in premenopausal women (ip < 0.001). CONCLUSION: Premenopausal women who are overweight and have poorer physical function have poorer prognosis at the time of diagnosis, suggesting the possible relevance of stratifying adjuvant treatment according to guidelines, BMI, and menopausal status.

Preloss grief in family caregivers during end-of-life cancer care: A nationwide population-based cohort study.

OBJECTIVE: Severe grief symptoms in family caregivers during end-of-life cancer trajectories are associated with complicated grief and depression after the loss. Nevertheless, severe grief symptoms during end-of-life caregiving in caregivers to cancer patients have been scarcely studied. We aimed to explore associations between severe preloss grief symptoms in caregivers and modifiable factors such as depressive symptoms, caregiver burden, preparedness for death, and end-of-life communication. METHODS: We conducted a population-based prospective study of caregivers to 9512 patients registered with drug reimbursement due to terminal illness, and 3635 caregivers responded. Of these, 2865 caregivers to cancer patients completed a preloss grief scale (Prolonged Grief 13, preloss version). Associations with factors measured during end-of-life caregiving were analyzed using logistic regression. RESULTS: Severe preloss grief symptoms were reported by 432 caregivers (15.2%). These symptoms were associated with depressive symptoms (adjusted odds ratio [OR] = 12.4; 95% CI, 9.5-16.3), high caregiver burden (adjusted OR = 8.3; 95% CI, 6.3-11.1), low preparedness for death (adjusted OR = 3.3; 95% CI, 2.5-4.4), low level of communication about dying (adjusted OR = 3.2; 95% CI, 2.2-4.4), and "too much" prognostic information (adjusted OR = 2.8; 95%, 1.7-4.6). CONCLUSIONS: Severe preloss grief symptoms were significantly associated with distress, low preparedness, and little communication during caregiving. Thus, severe preloss grief symptoms may be a key indicator for complications in caregivers of cancer patients in an end-of-life trajectory. Targeted interventions are needed to support family caregivers with severe preloss grief symptoms. Development of preloss grief assessment tools and interventions should be a priority target in future research.

Is admittance to specialised palliative care among cancer patients related to sex, age and cancer diagnosis? A nation-wide study from the Danish Palliative Care Database (DPD).

BACKGROUND: Specialised palliative care (SPC) takes place in specialised services for patients with complex symptoms and problems. Little is known about what determines the admission of patients to SPC and whether there are differences in relation to institution type. The aims of the study were to investigate whether cancer patients' admittance to SPC in Denmark varied in relation to sex, age and diagnosis, and whether the patterns differed by type of institution (hospital-based palliative care team/unit, hospice, or both). METHODS: This was a register-based study of adult patients living in Denmark who died from cancer in 2010-2012. Data sources were the Danish Palliative Care Database, Danish Register of Causes of Death and Danish Cancer Registry. The associations between the explanatory variables (sex, age, diagnosis) and admittance to SPC were investigated using logistic regression. RESULTS: In the study population (N = 44,548) the overall admittance proportion to SPC was 37%. Higher odds of overall admittance to SPC were found for women (OR = 1.23; 1.17-1.28), younger patients (<40 compared with 80+ years old) (OR = 6.44; 5.19-7.99) and patients with sarcoma, pancreatic and stomach cancers, whereas the lowest were for patients with haematological malignancies. The higher admission found for women was most pronounced for hospices compared to hospital-based palliative care teams/units, whereas higher admission of younger patients was more pronounced for hospital-based palliative care teams/units. Patients with brain cancer were more often admitted to hospices, whereas patients with prostate cancer were more often admitted to hospital-based palliative care teams/units. CONCLUSION: It is unlikely that the variations in relation to sex, age and cancer diagnoses can be fully explained by differences in need. Future research should investigate whether the groups having the lowest admittance to SPC receive sufficient palliative care elsewhere.

A process evaluation of systematic risk and needs assessment for caregivers in specialised palliative care.

BACKGROUND: Caregiving is strenuous and it may be associated with adverse psychological outcomes. During the palliative care trajectory, there are unique opportunities for providing support and preventing poor bereavement outcome. However, the tasks of palliative care staff in relation to caregivers are often unclear in the daily practice. Assessment is recommended to establish risk and needs and standards for caregiver support are available. Still, the feasibility of applying these standards among caregivers in everyday clinical practice has not been tested so far. METHODS: This study tested the feasibility of an intervention based on key elements of the "Bereavement support standards for specialist palliative care services" in a Danish specialised palliative home care team. We followed the UK Medical Research Council's guidelines for the process evaluation of complex interventions. The intervention consisted of: 1. Systematic risk and needs assessment for caregivers at care entry; 2. Interdisciplinary conference to prepare a support plan; 3. Targeted support; 4. The establishment of an electronic medical record for caregivers to document targeted support. Outcomes included the reach, fidelity and acceptability of the intervention as well as the assessment of contextual factors. RESULTS: The intervention reached 76 of 164 caregivers (46%). The interdisciplinary risk assessment and documentation of a support plan was conducted in 57 (75%) of the enrolled caregivers. Finally, a separate medical record was established according to the intervention blueprint for 62% of caregivers receiving targeted support. After managing initial challenges, palliative care staff reported that the intervention was useful and acceptable. CONCLUSION: The intervention proved feasible and useful. Still, we identified barriers to the implementation which should be taken into consideration when planning implementation of a systematic risk and needs assessment and in the establishment of medical records for caregivers.

Psychological distress, health, and socio-economic factors in caregivers of terminally ill patients: a nationwide population-based cohort study.

PURPOSE: At some point in life, most people become caregivers to a terminally ill relative. Previous studies have shown that many caregivers experience psychological distress and declining physical health, but these studies have predominantly been conducted in specialized palliative care settings. Therefore, caregiver studies with a population-based approach are needed. We aimed to describe socio-economic characteristics, situational factors, pre-loss grief symptoms, depressive symptoms, caregiver burden, and health status in a general population of caregivers to terminally ill patients. METHOD: We conducted a nationwide population-based cohort study. Caregivers were systematically recruited through patients registered with drug reimbursement for terminal illness in 2012. Data on socio-economic characteristics was mainly obtained from Danish registries, whereas data on situational factors, distress, and health was measured in questionnaires. RESULTS: Of patients to responding caregivers (n = 3635), 89 % suffered from cancer, predominantly lung cancer (23 %). Of responding caregivers, 62 % were partners and 29 % were adult children. In total, one third of caregivers reported severe outcome, 15 % reported severe pre-loss grief symptoms, 16.1 % had moderate to severe depressive symptoms, and 12 % experienced high caregiver burden. Partners had the highest levels of pre-loss grief and depressive symptoms, while adult children reported the highest levels of caregiver burden. CONCLUSIONS: From this cohort, which was estimated to be representative of caregivers to terminally ill relatives in the general population, we found high levels of pre-loss grief, depressive symptoms, and/or caregiver burden in one third of all caregivers. These findings call for increased focus on caregivers' need of support.

Factors associated with preference for dying at home among terminally ill patients with cancer.

INTRODUCTION: An important element in end-of-life care advocacy is to meet patients' end-of-life preferences. Most Scandinavian patients die in hospitals even though the majority prefers to die at home. Earlier studies have shown socio-economic differences in relation to dying at home, but more knowledge is needed in relation to preferences for place of death. Hence, on valid Danish register-based socio-economic data, we aimed to investigate whether demographic and socio-economic factors were associated with preference for dying at home. METHOD: Population-based, historic cohort study among 282 relatives of deceased patients who died of cancer in Denmark in 2006. Bereaved relatives were asked to state patient's preference concerning place of death at the beginning and end of the palliative period. These data were recently combined with updated, extensive demographic and socio-economic data from Danish national health registers. Generalised linear models were used modelling prevalence ratio (PR). RESULTS: We found a significant positive association at the beginning of the palliative trajectory between preferring home death and being male (PR = 1.26 (95% CI: 1.00;1.58) (p = 0.048)) and a significant negative association between having medium income compared with high income (PR = 0.81 (95% CI 0.67;0.98) (p = 0.031)). At the end of the palliative trajectory, a significant negative association was found between preferring home death and living in a community with more than 100 000 inhabitants (PR = 0.63 (95% CI 0.45;0.89) (p = 0.008)) compared with living in communities with less than 10 000 inhabitants. CONCLUSION: The study showed that socio-economic factors such as gender, level of income and size of community were associated with preference for dying at home. Hence, this study qualifies prior studies on preferences for end-of-life care and advocates for a more nuanced picture of the subject. Advocacy in end-of-life nursing recommends optimising active listening and communication skills striving towards more patients' preferences in all settings may be heard and fulfilled.

Intensive care at the end of life in patients dying due to non-cancer chronic diseases versus cancer: a nationwide study in Denmark.

INTRODUCTION: It is unknown to what extent use of palliative care and focus on proactive planning of end-of-life (EOL) care among cancer patients is also reflected by less use of intensive care. We aimed to examine the use of intensive care in the EOL in patients dying as a result of non-cancer diseases compared with patients dying due to cancer. METHODS: We conducted a nationwide follow-up study among 240,757 adults dying as a result of either non-cancer chronic disease or cancer in Denmark between 2005 and 2011. Using the Danish Intensive Care Database, we identified all admissions and treatments in intensive care units (ICU) during the patients' last 6 months before death. We used prevalence ratios (aPRs) adjusted for age, sex, comorbidity, marital status and residential region to compare the 6-month prevalence of ICU admissions as well as treatment with invasive mechanical ventilation (MV), non-invasive ventilation (NIV), renal replacement therapy (RRT) and inotropes and/or vasopressors. In addition, length of ICU stay and death during ICU admission were compared among non-cancer and cancer patients dying between 2009 and 2011. RESULTS: Overall 12.3 % of non-cancer patients were admitted to an ICU within their last 6 months of life, compared with 8.7 % of cancer patients. The overall aPR for ICU admission was 2.11 [95 % confidence interval (CI) 1.98-2.24] for non-cancer patients compared with cancer patients and varied widely within the non-cancer patients (patients with dementia, aPR 0.19, 95 % CI 0.17-0.21; patients with chronic obstructive lung disease, aPR 3.19, 95 % CI 2.97-3.41). The overall aPRs for treatment among non-cancer patients compared with cancer patients were 1.40 (95 % CI 1.35-1.46) for MV, 1.62 (95 % CI 1.50-1.76) for NIV, 1.19 (95 % CI 1.07-1.31) for RRT and 1.05 (95 % CI 0.87-1.28) for inotropes and/or vasopressors. No difference in admission length was observed. Non-cancer patients had an increased risk of dying in an ICU (aPR 1.23, 95 % CI 0.99-1.54) compared with cancer patients. CONCLUSIONS: Overall, patients dying as a result of non-cancer diseases were twice as likely to be admitted to ICUs at the EOL as patients dying due to cancer. Further studies are warranted to explore whether this difference in use of intensive care reflects an unmet need of palliative care, poor communication about the EOL or lack of prognostic tools for terminally ill non-cancer patients.