The association between education and fear of recurrence among breast cancer patients in follow-up - and the mediating effect of self-efficacy.

BACKGROUND: Major restructuring of surveillance after breast cancer treatment with less follow-up consultations may result in insecurity and fear of recurrence (FCR) among the less resourceful breast cancer patients. We investigate the association between breast cancer patients' education and FCR and if self-efficacy mediates the associations between education and FCR. MATERIAL AND METHODS: A questionnaire survey was conducted from 2017 to 2019, among 1773 breast cancer patients shortly after having their follow-up switched from regular outpatient visits with an oncologist to either nurse-led or patient-initiated follow-up, with a subsequent questionnaire after 12 months. Data on disease and treatment characteristics were extracted from medical records and the Danish Breast Cancer Group Database. Logistic regression analyses were used to examine the association between education and FCR. Separate analyses were conducted for patients ≤ and >5 years since diagnosis and all models were adjusted for age and cohabitation status. To explore potential mediation by self-efficacy, we conducted regression analyses on education and FCR further adjusting for self-efficacy. RESULTS: The participation rate was 57%, and after the exclusion of patients due to missing data, 917 were included in analyses. Patients with long education had significantly less FCR compared to patients with short education (OR (95% CI) 0.71 (0.51;0,99)). When separated by time since diagnosis, there was no association among patients >5 years since diagnosis while the OR was 0.51 (95% CI, 0.30;0.85) for patients ≤5 years since diagnosis. Further adjusting for self-efficacy among patients <5 years since diagnosis resulted in an OR of 0.56 (95% CI, 0.33;0.95) among patients with long compared to short education. CONCLUSION: Up to 5 years after diagnosis, breast cancer patients with long education are less likely to experience FCR than patients with short education. Self-efficacy mediated only a very small part of this association, indicating that other factors play a role in socioeconomic differences in FCR among breast cancer patients.

Effects on Pediatric Cancer Survivors: The FAMily-Oriented Support (FAMOS) Randomized Controlled Trial.

OBJECTIVE: To examine as secondary analyses the effect the FAMily-Oriented Support (FAMOS) family therapy program on reducing parent-reported medical traumatic stress in the sub-sample of pediatric cancer survivors, age 2-5 years. METHODS: The FAMOS study was a national multicenter randomized controlled trial with all four pediatric oncology departments in Denmark (Clinicaltrials.gov [NCT02200731]). Families were randomized in parallel design (1:1) to intervention or usual care. The FAMOS program includes seven home-based psychotherapeutic sessions and is based on family systems therapy to address the individuals in the family system using cognitive behavioral, problem-solving and goal-setting techniques. Questionnaires were completed by parents at baseline, 6, and 12 months. In linear mixed-effects models, the effect of FAMOS on reducing children's trauma-related behavior after 6 and 12 months was examined in 62 children (31 in the intervention and 29 in the control group, respectively). It was also examined if a trauma-related behavior effect was mediated through reduced symptoms of depression in mothers and fathers, respectively. RESULTS: On average, children in the intervention group experienced significantly larger decreases in trauma-related behaviors at 6 and 12 months than the control group (predicted mean difference -3.89, p = .02 and -6.24, p = .003, respectively). The effect on trauma-related behavior was partly mediated through reduced symptoms of depression in mothers, but not fathers. CONCLUSIONS: Adding to previously reported positive effects of the FAMOS intervention on parents' symptoms of post-traumatic stress and depression, significant improvements were found in young children's trauma related-behavior. Further research is needed to develop therapy for children with cancer.

Pregnancy outcomes in women with neurofibromatosis 1: a Danish population-based cohort study.

BACKGROUND: The probability of a pregnancy, live birth, stillbirth and abortion has never been assessed in women with neurofibromatosis 1 (NF1) in a large population-based study. METHODS: We included 1006 women (15-49 years) registered with NF1 in the Danish National Patient Registry or followed in two national Centers for Rare Diseases and 10 020 women from the Danish population. Information on pregnancy outcomes was ascertained from health registries. Cumulative incidence, mean cumulative count, hazard ratios (HRs) and proportion ratios (PRs) with 95% CIs were calculated. RESULTS: The cumulative incidence of a first pregnancy at age 50 years was slightly lower in women with NF1 (74%; 95% CI 70 to 77) than in population comparisons (78%; 95% CI 77 to 79). When all pregnancies were included, two pregnancies were expected per woman at age of 50 years, irrespective of a NF1 diagnosis. The hazard of a pregnancy did not differ between women with NF1 (HR 1.03; 95% CI 0.95 to 1.11) and the comparisons after adjustment for somatic and psychiatric disease. The proportion of pregnancies that resulted in a live birth was 63% (783/1252) among women NF1 and 68% (8432/12 465) among the comparisons, yielding a PR of 0.95 (95% CI 0.90 to 1.00). The proportions of stillbirths (PR 2.83; 95% CI 1.63 to 4.93) and spontaneous abortions (PR 1.40; 95% CI 1.09 to 1.79) were increased in women with NF1. CONCLUSIONS: A similar hazard for pregnancy was observed for women with NF1 and population comparisons after adjustment for potential medical consequences of NF1. However, women with NF1 experienced more spontaneous abortions and stillbirths.

Patients in phase 1 cancer trials: psychological distress and understanding of trial information.

BACKGROUND: Psychological distress may be present among patients who are considering enrollment in phase 1 cancer trials, as they have advanced cancer and no documented treatment options remain. However, the prevalence of psychological distress has not been previously investigated in larger cohorts. In complex phase 1 cancer trials, it is important to ensure adequate understanding of the study premises, such as the undocumented effects and the risk of adverse events. MATERIALS AND METHODS: In a prospective study, patients completed questionnaires at two time points. We investigated psychological distress, measured as stress, anxiety, and depression, among patients at their first visit to the phase 1 unit (N = 229). Further, we investigated the understanding of trial information among patients who were enrolled in a phase 1 cancer trial (N = 57). RESULTS: We enrolled 75% of 307 eligible patients. We found a lower mean score of stress in our population compared to population norms, while the mean scores of anxiety and depression were higher. A total of 9% showed moderate to severe symptoms of anxiety and 11% showed moderate to severe symptoms of depression, which indicates higher levels than cancer patients in general. A total of 46 (81% of enrolled patients) completed questionnaires on trial information and consent. The understanding of the information on phase 1 cancer trials in these patients was slightly lower than the level reported for cancer trials in general. Some aspects relating to purpose, benefit, and additional risks were understood by fewer than half of the patients. CONCLUSION: Our results suggest that distress is not as prevalent in the population of patients referred to phase 1 cancer trials as in the general cancer population. Although patients' understanding of trial information was reasonable, some aspects of complex phase 1 cancer trials were not easily understood by enrolled patients.

Cannabis use among Danish patients with cancer: a cross-sectional survey of sociodemographic traits, quality of life, and patient experiences.

PURPOSE: Patients with cancer are using cannabis for self-treatment. The reasons, experienced effects, and prevalence of use are unknown in the European general oncological population. METHODS: Adult patients with cancer attending outpatient oncology clinics were invited to participate in a cross-sectional survey. The questionnaire consisted of sociodemographic questions, validated scales on quality of life, neuropathy, anxiety and depression as well as questions regarding use of cannabis. RESULTS: The overall response rate was 83% (2839 patients) and 13% of patients were using or had used cannabis during their treatment. Rate of use was higher in smokers (19% vs 11%, p adjusted 0.002), in patients in active cancer treatment (14% vs 10%, p adjusted = 0.02), and in patients with depression (19% vs 11%, adjusted p = 0.002). Cannabis use was also correlated with lower quality of life (EORTC C30 SumScore mean diff. = - 7.61, 95% CI = [- 9.69; - 5.53]). In total, 77% of users experienced at least one positive effect of cannabis, 18% experienced no effect, and 5% experienced other effects. At least one side effect was experienced by 33% of users. Management of pain and nausea were the primary reasons for initiating cannabis use (39% for both). Less nausea and better sleep were the most common effects experienced (26% for both). Oils for oral use were the most common route of administration (88%). CONCLUSION: Cannabis use among patients with cancer is prevalent and correlated with worse quality of life. Patients report using cannabis for symptom management and many experience relief of their symptoms. However, one third of patients experienced side effects.

Psychiatric disorders in individuals with neurofibromatosis 1 in Denmark: A nationwide register-based cohort study.

The aim of this study was to assess the risks of psychiatric disorders in a large cohort of 905 individuals with NF1 and 7614 population comparisons matched on sex and year of birth. The cohort was linked to the Danish Psychiatric Central Research Register to ascertain information on hospital contacts for psychiatric disorders based on the International Classification of Diseases version 8 and 10. The hazard ratio (HR) for a first psychiatric hospital contact was higher in girls (4.19, 95% confidence interval [CI] 1.81-9.69) and boys with NF1 (5.02, 95% CI 3.27-7.69) <7 years of age than in the population comparisons. Both sexes had increased HRs for developmental disorders, including attention deficit/hyperactivity disorders, autism spectrum disorders, and intellectual disabilities in childhood. Females with NF1 had also increased HRs for unipolar depression, other emotional and behavioral disorders, and severe stress reaction and adjustment disorders in early adulthood. The HRs for psychoses, schizophrenia, bipolar disorders, and substance abuse were similar in individuals with NF1 and the population comparisons. Finally, the cumulative incidence of a first hospital contact due to any psychiatric disorder by age 30 years was 35% (95% CI 29-41) in females and 28% (95% CI 19-37) in males with NF1. Thus, screening for psychiatric disorders may be important for early diagnosis and facilitation of appropriate and effective treatment in individuals with NF1.

High World Heath Organization Performance Status Is Associated With Short- and Long-term Outcomes After Colorectal Cancer Surgery: A Nationwide Population-Based Study.

BACKGROUND: The value of performance status is widely used in medical oncology, but the association with surgical outcomes in colorectal cancer has not been described. OBJECTIVE: The aim of this study was to investigate the association between World Heath Organization performance status and 90-day mortality, 30-day mortality, complications, and overall survival after elective colorectal cancer surgery. DESIGN: The study was conducted as a nationwide population-based cohort study with prospectively collected data. SETTING: Data from 2014 through 2016 were provided by the Danish nationwide colorectal cancer database (Danish Colorectal Cancer Group). PATIENTS: All patients aged ≥18, who had elective surgery for colorectal cancer were included. MAIN OUTCOME MEASURES: Multiple logistic regressions were performed to investigate 90-day mortality, 30-day mortality, and complications. One-year mortality was determined by Cox regression, and overall survival was illustrated by Kaplan-Meier curves. RESULTS: A total of 10,279 patients had elective colorectal cancer surgery during the study period (6892 colonic and 3387 rectal). Thirty-four percent of the patients with colorectal cancer had a World Heath Organization performance status ≥1. The odds ratios of postoperative 90-day mortality in colon cancer for performance status 1, 2, and 3/4 compared with performance status 0 were 2.50 (95% CI, 1.67-3.73), 5.00 (95% CI, 3.19-7.86), and 17.34 (95% CI, 10.18-29.55). The odds ratios of postoperative 90-day mortality in rectal cancer for performance status 1, 2, and 3/4 were 3.90 (95% CI, 2.23-6.85), 9.25 (95% CI, 4.75-18.02), and 10.56 (95% CI, 4.07-27.41). Performance status was also associated with 30-day mortality, overall survival, and medical complications. LIMITATIONS: Only 1 year of follow-up was possible for all patients, and cancer-specific survival was not available. CONCLUSION: One of three patients has a performance status >0 and is associated with an increased risk of death, complications, and overall survival for both colonic and rectal cancers. See Video Abstract at http://links.lww.com/DCR/B540. EL ALTO NIVEL DE DESEMPEO DE LA ORGANIZACIN MUNDIAL DE LA SALUD SE ASOCIA CON RESULTADOS A CORTO Y LARGO PLAZO DESPUS DE LA CIRUGA DEL CNCER COLORRECTAL UN ESTUDIO POBLACIONAL A NIVEL NACIONAL: ANTECEDENTES:El valor del estado funcional se usa ampliamente en oncología médica, pero no se ha descrito la asociación con los resultados quirúrgicos en el cáncer colorrectal.OBJETIVO:El objetivo fue investigar la asociación entre el estado funcional de la Organización Mundial de la Salud y la mortalidad a 90 días, la mortalidad a 30 días, las complicaciones y la supervivencia general después de la cirugía electiva del cáncer colorrectal.DISEÑO:El estudio se realizó como un estudio de cohorte poblacional a nivel nacional con datos recolectados prospectivamente.ENTORNO CLINICO:Los datos fueron proporcionados por la base de datos de cáncer colorrectal a nivel nacional danés (DCCG.dk) en un período de estudio de 2014-2016.PACIENTES:Se incluyeron todos los pacientes de ≥18 años que se sometieron a cirugía electiva por cáncer colorrectal.PRINCIPALES MEDIDAS DE VALORACION:Para investigar la mortalidad a los 90 días, la mortalidad a los 30 días y las complicaciones se realizaron regresiones logísticas múltiples. La mortalidad a un año se determinó mediante regresión de Cox y la supervivencia general se ilustra mediante curvas de Kaplan-Meier.RESULTADOS:Un total de 10 279 pacientes se sometieron a cirugía electiva de cáncer colorrectal en el período de estudio (6892 colónico y 3387 rectal). Treinta y cuatro por ciento de los pacientes con cáncer colorrectal tenían un estado funcional de la Organización Mundial de la Salud ≥1. Los ratios de probabilidades (odds ratios) de mortalidad postoperatoria a los 90 días en cáncer de colon para el estado funcional 1, 2 y 3/4 en comparación con el estado funcional 0 fueron 2,50 (IC del 95%: 1,67-3,73), 5,00 (IC del 95%: 3,19-7,86) y 17,34 (IC del 95%: 10,18-29,55), respectivamente. Los ratios de probabilidades de mortalidad postoperatoria de 90 días en cáncer de recto para el estado funcional 1, 2 y 3/4 fueron 3,90 (IC del 95%: 2,23-6,85), 9,25 (IC del 95%: 4,75-18,02) y 10,56 (IC del 95%: 2,23-6,85) % CI: 4,07-27,41). El estado funcional también se asoció con la mortalidad a los 30 días, la supervivencia general y las complicaciones médicas.LIMITACIONES:Solo fue posible un año de seguimiento para todos los pacientes y la supervivencia específica del cáncer no estaba disponible.CONCLUSIÓN:Uno de cada tres pacientes tiene un estado funcional> 0 y se asocia con un mayor riesgo de muerte, complicaciones y supervivencia general para los cánceres de colon y recto. Consulte Video Resumen en http://links.lww.com/DCR/B540.

Multisystem burden of neurofibromatosis 1 in Denmark: registry- and population-based rates of hospitalizations over the life span.

PURPOSE: The aim was to assess lifetime risk for hospitalization in individuals with neurofibromatosis 1 (NF1). METHODS: The 2467 individuals discharged with a diagnosis indicating NF1 or followed in a clinical center for NF1 were matched to 20,132 general population comparisons. Based on diagnoses in 12 main diagnostic groups and 146 subcategories, we calculated rate ratios (RRs), absolute excess risks (AERs), and hazard ratios for hospitalizations. RESULTS: The RR for any first hospitalization among individuals with NF1 was 2.3 (95% confidence interval 2.2-2.5). A high AER was seen for all 12 main diagnostic groups, dominated by disorders of the nervous system (14.5% of all AERs), benign (13.6%) and malignant neoplasms (13.4%), and disorders of the digestive (10.5%) and respiratory systems (10.3%). Neoplasms, nerve and peripheral ganglia disease, pneumonia, epilepsy, bone and joint disorders, and intestinal infections were major contributors to the excess disease burden caused by NF1. Individuals with NF1 had more hospitalizations and spent more days in hospital than the comparisons. The increased risk for any hospitalization was observed for both children and adults, with or without an associated cancer. CONCLUSION: NF1 causes an overall greater likelihood of hospitalization, with frequent and longer hospitalizations involving all organ systems throughout life.

Cancer patients, physicians, and nurses differ in their attitudes toward the decisional role in do-not-resuscitate decision-making.

PURPOSE: Do-not-resuscitate (DNR) decision-making in severely ill patients presents many difficult medical, ethical, and legal challenges. The primary aim of this study was to explore cancer patients' and health care professionals' attitudes regarding DNR decision-making authority and timing of the decision. METHODS: This study was a questionnaire survey among Danish cancer patients and their attending physicians and nurses in an oncology outpatient setting. Potential differences between patients', physicians', and nurses' answers to the questionnaire were analyzed using Fisher's exact test. RESULTS: Responses from 904 patients, 59 physicians, and 160 nurses were analyzed. The majority in all three groups agreed that DNR decisions should be made in collaboration between physician and patient. However, one-third of the patients answered that the patient alone should make the decision regarding DNR, which contrasts with the physicians' and nurses' attitudes, 0% and 6% pointing to the patient as sole decision-maker, respectively. In case of disagreement between patient and physician, a majority of both patients (66%) and physicians (86%) suggested themselves as the ultimate decision-maker. Additionally, 43% of patients but only 19% of physicians preferred the DNR discussion being brought up early in the course of the disease. CONCLUSIONS: With regard to the decisional role of patient vs. physician and the timing of the DNR discussion, we found a substantial discrepancy between the attitudes of cancer patients and physicians. This discrepancy calls for a greater awareness and discussion of this sensitive topic among both health care professionals and the public.

Personality as a predictor of well-being in a randomized trial of a mindfulness-based stress reduction of Danish women with breast cancer.

Purpose: Many clinical interventions have been designed to improve psychological well-being in women with breast cancer; however, there are individual differences in the extent of benefit across participants. Mindfulness-Based Stress Reduction (MBSR) is a structured 8-week intervention that has been shown to reduce depression and anxiety for patients with breast cancer. Personality factors may influence which participants benefit more from various psychological interventions, including MBSR.Design: In a secondary analysis, we examined whether personality factors accounted for variability in response to an MBSR intervention for women with breast cancer.Sample: Two hundred eighty Danish women with breast cancer who completed the Mindfulness and Cancer Mamma trial were included in this analysis.Methods: Using multiple regression analyses, we investigated whether personality factors, measured by the NEO-PI-R, contribute independently or interact with treatment to predict depressive symptoms at 2, 6, and 12-month follow-up.Findings: The interaction between low conscientiousness and MBSR, as well as high neuroticism and MBSR each predicted significantly lower levels of distress at 12-month follow-up compared to women who higher in conscientious or lower in neuroticism.Conclusions: Personality factors may contribute to the impact of psychosocial interventions, such as MBSR, on psychological well-being.Implications for Psychosocial Providers: Utilizing personality measures may assist providers in identifying which patients may benefit from mindfulness therapies.

MyHealth: specialist nurse-led follow-up in breast cancer. A randomized controlled trial - development and feasibility.

Background: Traditionally, women treated for breast cancer (BC) have been followed up through regular oncologist-led visits in outpatient clinics, focusing on detection of recurrences, new primary BC, symptom management, and psychological support. However, this follow-up routine is expensive and its effectiveness has been questioned. Consequently, alternative follow-up programs have been tested. The Guided Self-Determination method (GSD), which facilitates partnership between health-care provider and patient, has been shown to improve self-management in patients with chronic conditions, including cancer. Patient-reported outcomes (PRO) is another increasingly used tool to improve patient-provider communication, symptom monitoring and control. In combination, GSD and PRO may have the potential to meet the objectives of BC follow-up. To test this, we developed the MyHealth study, a randomized controlled trial comparing a nurse-led follow-up program based on GSD, collection of PRO, and patient navigation with routine oncologist-led follow-up. Here we describe how we developed the intervention and are currently testing the feasibility of the MyHealth protocol in terms of recruitment, adherence to the intervention, collection of PRO, and patient navigation. Material and methods: We have invited the first 25 consecutively enrolled patients to test the MyHealth intervention. This consists of (1) 3-5 initial GSD appointments with a nurse, (2) collection of PRO, and (3) symptom management and patient navigation. The randomized trial was launched in January 2017 and is still recruiting. Results of the feasibility study: Of 32 patients invited, 25 accepted participation. At 18-month follow-up, two patients have withdrawn, 143 PRO questionnaires have been completed (mean 5.7/patient) resulting in 59 nurse contacts (mean 2.4 per patient) and 14 project physician contacts (mean 0.6 per patient). Conclusion: A high recruitment rate and response rate to PRO indicate that follow-up led by specialist nurses, based on collection of PRO is feasible and acceptable for patients treated for early stage BC.

Follow-up strategies following completion of primary cancer treatment in adult cancer survivors.

BACKGROUND: Most cancer survivors receive follow-up care after completion of treatment with the primary aim of detecting recurrence. Traditional follow-up consisting of fixed visits to a cancer specialist for examinations and tests are expensive and may be burdensome for the patient. Follow-up strategies involving non-specialist care providers, different intensity of procedures, or addition of survivorship care packages have been developed and tested, however their effectiveness remains unclear. OBJECTIVES: The objective of this review is to compare the effect of different follow-up strategies in adult cancer survivors, following completion of primary cancer treatment, on the primary outcomes of overall survival and time to detection of recurrence. Secondary outcomes are health-related quality of life, anxiety (including fear of recurrence), depression and cost. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, four other databases and two trials registries on 11 December 2018 together with reference checking, citation searching and contact with study authors to identify additional studies. SELECTION CRITERIA: We included all randomised trials comparing different follow-up strategies for adult cancer survivors following completion of curatively-intended primary cancer treatment, which included at least one of the outcomes listed above. We compared the effectiveness of: 1) non-specialist-led follow-up (i.e. general practitioner (GP)-led, nurse-led, patient-initiated or shared care) versus specialist-led follow-up; 2) less intensive versus more intensive follow-up (based on clinical visits, examinations and diagnostic procedures) and 3) follow-up integrating additional care components relevant for detection of recurrence (e.g. patient symptom education or monitoring, or survivorship care plans) versus usual care. DATA COLLECTION AND ANALYSIS: We used the standard methodological guidelines by Cochrane and Cochrane Effective Practice and Organisation of Care (EPOC). We assessed the certainty of the evidence using the GRADE approach. For each comparison, we present synthesised findings for overall survival and time to detection of recurrence as hazard ratios (HR) and for health-related quality of life, anxiety and depression as mean differences (MD), with 95% confidence intervals (CI). When meta-analysis was not possible, we reported the results from individual studies. For survival and recurrence, we used meta-regression analysis where possible to investigate whether the effects varied with regards to cancer site, publication year and study quality. MAIN RESULTS: We included 53 trials involving 20,832 participants across 12 cancer sites and 15 countries, mainly in Europe, North America and Australia. All the studies were carried out in either a hospital or general practice setting. Seventeen studies compared non-specialist-led follow-up with specialist-led follow-up, 24 studies compared intensity of follow-up and 12 studies compared patient symptom education or monitoring, or survivorship care plans with usual care. Risk of bias was generally low or unclear in most of the studies, with a higher risk of bias in the smaller trials. Non-specialist-led follow-up compared with specialist-led follow-up It is uncertain how this strategy affects overall survival (HR 1.21, 95% CI 0.68 to 2.15; 2 studies; 603 participants), time to detection of recurrence (4 studies, 1691 participants) or cost (8 studies, 1756 participants) because the certainty of the evidence is very low. Non-specialist- versus specialist-led follow up may make little or no difference to health-related quality of life at 12 months (MD 1.06, 95% CI -1.83 to 3.95; 4 studies; 605 participants; low-certainty evidence); and probably makes little or no difference to anxiety at 12 months (MD -0.03, 95% CI -0.73 to 0.67; 5 studies; 1266 participants; moderate-certainty evidence). We are more certain that it has little or no effect on depression at 12 months (MD 0.03, 95% CI -0.35 to 0.42; 5 studies; 1266 participants; high-certainty evidence). Less intensive follow-up compared with more intensive follow-up Less intensive versus more intensive follow-up may make little or no difference to overall survival (HR 1.05, 95% CI 0.96 to 1.14; 13 studies; 10,726 participants; low-certainty evidence) and probably increases time to detection of recurrence (HR 0.85, 95% CI 0.79 to 0.92; 12 studies; 11,276 participants; moderate-certainty evidence). Meta-regression analysis showed little or no difference in the intervention effects by cancer site, publication year or study quality. It is uncertain whether this strategy has an effect on health-related quality of life (3 studies, 2742 participants), anxiety (1 study, 180 participants) or cost (6 studies, 1412 participants) because the certainty of evidence is very low. None of the studies reported on depression. Follow-up strategies integrating additional patient symptom education or monitoring, or survivorship care plans compared with usual care: None of the studies reported on overall survival or time to detection of recurrence. It is uncertain whether this strategy makes a difference to health-related quality of life (12 studies, 2846 participants), anxiety (1 study, 470 participants), depression (8 studies, 2351 participants) or cost (1 studies, 408 participants), as the certainty of evidence is very low. AUTHORS' CONCLUSIONS: Evidence regarding the effectiveness of the different follow-up strategies varies substantially. Less intensive follow-up may make little or no difference to overall survival but probably delays detection of recurrence. However, as we did not analyse the two outcomes together, we cannot make direct conclusions about the effect of interventions on survival after detection of recurrence. The effects of non-specialist-led follow-up on survival and detection of recurrence, and how intensity of follow-up affects health-related quality of life, anxiety and depression, are uncertain. There was little evidence for the effects of follow-up integrating additional patient symptom education/monitoring and survivorship care plans.

Depressive symptoms and mental health-related quality of life in adolescence and young adulthood after early parental death.

Aims: Little is known about long-term mental health in young adults who participate in ongoing grief counseling programs after early parental death in childhood, adolescence or young adulthood. The purpose of this study was to examine mental health in young adults according to early parental death and participation in grief counseling. Methods: In a cross-sectional, questionnaire-based study, we included three samples of young adults age 18-41 years. One sample who had lost a parent between age 0 and 30 years and who had participated in grief counseling identified through four Danish grief-counseling organizations, and two registry-based samples of young adults included parentally bereaved and non-bereaved young adults. Multivariate-adjusted regression analyses were performed to characterize risk of depressive symptoms and mental health-related quality of life (HQoL) according to early parental death and participation in grief counseling. Results: A total of 2467 (45%) young adults participated. Bereaved young adults reported significantly more depressive symptoms (p<0.0001) and lower mental HQoL (p<0.0001) than non-bereaved young adults and than general population levels for both depressive symptoms (p<0.0001) and HQoL (p<0.0001). Bereaved young adults who had participated in grief counseling reported significantly more depressive symptoms (p<0.0001) and lower mental HQoL (p<0.0001) than bereaved persons who did not participate in grief counseling. Conclusions: Bereaved young adults report more mental health problems than non-bereaved young adults, and also after participation in grief counseling the death of a parent may be accompanied by subsequent mental health problems.

Why do general practitioners not refer patients to behaviour-change programmes after preventive health checks? A mixed-method study.

BACKGROUND: This study was embedded in the Check-In randomised controlled trial that investigated the effectiveness of general practice-based preventive health checks on adverse health behaviour and early detection of non-communicable diseases offered to individuals with low socioeconomic positions. Despite successful recruitment of patients, the intervention had no effect. One reason for the lack of effectiveness could be low rates of referral to behaviour-change programmes in the municipality, resulting in a low dose of the intervention delivered. The aim of this study is to examine the referral pattern of the general practitioners and potential barriers to referring eligible patients to these behaviour-change programmes. METHODS: A mixed-method design was used, including patients' questionnaires, recording sheet from the health checks and semi-structured qualitative interviews with general practitioners. All data used in the study were collected during the time of the intervention. Logistic regressions were used to estimate odds ratios for being eligible and for receiving referrals. The qualitative empirical material was analysed thematically. Emerging themes were grouped, discussed and the material was re-read. The themes were reviewed alongside the analysis of the quantitative material to refine and discuss the themes. RESULTS: Of the 364 patients, who attended the health check, 165 (45%) were marked as eligible for a referral to behaviour-change programme by their general practitioner and of these, 90 (55%) received referrals. Daily smoking (OR = 3.22; 95% CI:2.01-5.17), high-risk alcohol consumption (OR = 2.66; 95% CI:1.38-5.12), obesity (OR = 2.89; 95% CI:1.61-5.16) and poor lung function (OR = 2.05; 95% CI:1.14-3.70) were all significantly associated with being eligible, but not with receiving referral. Four themes emerged as the main barriers to referring patients to behaviour-change programmes: 1) general practitioners' responsibility and ownership for their patients, 2) balancing information and accepting a rejection, 3) assessment of the right time for behavioural change and 4) general practitioners' attitudes towards behaviour-change programmes in the municipality. CONCLUSION: We identified important barriers among the general practitioners which influenced whether the patients received referrals to behaviour-change programmes in the municipality and thereby influenced the dose of intervention delivered in Check-In. The findings suggest that an effort is needed to assist the collaboration between general practices and the municipalities' primary preventive services. TRIAL REGISTRATION: Clinical Trials NCT01979107 ; October 25, 2013.

Risk for use of antidepressants, anxiolytics, and hypnotics in partners of glioma patients-A nationwide study covering 19 years of prescriptions.

OBJECTIVE: Suffering from malignant brain tumor is a stressful condition, for patients and their partners. In a retrospective cohort study using nationwide registries, we examined partners' risk for first use of antidepressants, anxiolytics, or hypnotics. METHODS: We followed all 4373 partners of adults with glioma, diagnosed in 1998 to 2013 in Denmark and a cohort of 43 808 partners of glioma-free persons matched 1:10. In Cox proportional hazard models, we estimated hazard ratios (HRs) for a first prescription of psychotropic medications (antidepressants, anxiolytics, or hypnotics) according to the partner's glioma status. Among partners of glioma patients, we further estimated HRs for a first prescription of psychotropic medication according to disease characteristics, sociodemographic factors, and bereavement. RESULTS: Two years after diagnosis, 29% of female and 21% of male partners of glioma patients had had a first prescription of psychotropic medication compared with 10% in female and 8% in male partners of glioma-free persons. Partners of glioma patients had a significantly increased, 4-fold higher risk for a first prescription of psychotropic medications in the first year after diagnosis than partners of glioma-free persons (HR 4.10, 95% CI, 3.80:4.43). Among partners of glioma patients, the risk was significantly reduced in bereaved compared with non-bereaved partners. CONCLUSIONS: We have documented, for the first time, that the psychological impact of a diagnosis of glioma is such a severe stress exposure that it increases the risk for having medication prescribed to treat symptoms of anxiety, sleep problems, and depression.

First use of antidepressant medication in male partners of women with breast cancer in Denmark from 1998 to 2011.

OBJECTIVE: A diagnosis of breast cancer disrupts the life of the patient, but also the partner may experience adverse psychological effects. We examined partners' risk for first use of antidepressant medication, as a proxy for pharmacologically treated depression. METHODS: By linkage of national registers, we identified 1 420 592 depression-free men living with a cancer-free female partner in 1998 to 2011. During follow-up, breast cancer was diagnosed in female partners of 26 256 men. In Poisson regression models, we estimated the rate ratios for first use of antidepressant medication compared to partners of breast cancer-free women. Cox regression analyses examined associations between exposed partners' sociodemographic characteristics, somatic comorbidity, death of female partner, and first use of antidepressant medication. RESULTS: Male partners of women with breast cancer had an increased rate ratio of 1.08 (95% CI, 1.03-1.13) for first use of antidepressant medication compared to the background population, corresponding to excess absolute risk of 12 cases per 10 000 person-years. This increased risk persisted throughout 14 years of follow-up. Higher age, shorter education, somatic comorbidity, and death of female partner were associated with increased risk among men whose partner had breast cancer. CONCLUSION: The modest, but long term, increased risk for first use of antidepressant medication calls for attention by health care professionals to symptoms of depression among partners of breast cancer patients.

Genetic variants in 5-HTTLPR, BDNF, HTR1A, COMT, and FKBP5 and risk for treated depression after cancer diagnosis.

BACKGROUND: The role of gene-environment interactions in the pathogenesis of depression is unclear. Previous studies addressed vulnerability for depression after childhood adversity and stressful life events among carriers of numerous specific genetic variants; however, the importance of individual genetic variants, the environmental exposures with which they interact, and the magnitude of the risk conveyed by these interactions remain elusive. METHODS: We included 7,320 people with a first primary cancer identified in the prospective Diet, Cancer and Health study in an exposed-only cohort study. The mean age of the individuals was 68 years (5th, 95th percentiles: 58, 78) at cancer diagnosis. Using Cox regression models and cumulative incidence plots, we analyzed the associations between genetic variants in 5-HTTLPR, BDNF, HTR1A, COMT, and FKBP5 and use of antidepressants as well as hospital contact for depression after diagnosis of cancer. RESULTS: Overall, we observed no statistically significant associations, with nonsignificant hazard ratio estimates for use of antidepressants of 0.95-1.07. CONCLUSIONS: This study of elderly people indicates that it is unlikely that the investigated genetic variants are clinically relevantly associated with depression after diagnosis of cancer. The mechanisms for gene-environment interactions in younger individuals are probably different, and we advise caution in extrapolating our results to early life stress. However, conclusion from the present study might be generalizable to elderly persons exposed to other stressful life events.

Swallowing therapy and progressive resistance training in head and neck cancer patients undergoing radiotherapy treatment: randomized control trial protocol and preliminary data.

BACKGROUND: Head and neck cancer (HNC) patients are often challenged by treatment induced dysphagia and trismus. Traditionally, rehabilitation is initiated when loss of function has already occurred. There is increasing evidence that it is of benefit to patients to initiate an early rehabilitation process before and during treatment. HNC patients have a unique set of functional challenges such as pre- and post-treatment dysphagia, pain and weight loss. The aim of the trial is to investigate the effects of swallowing and mouth-opening exercises combined with progressive resistance training (PRT) during radiotherapy. This report presents the protocol, interim inclusion and feasibility data. MATERIAL AND METHODS: The trial (clinicaltrials.gov NCT02385929) is a multicenter randomized controlled trial (RCT) with a parallel-group randomization (1:1). The planned sample size of 240 HNC patients is randomly assigned to either (1) twice weekly PRT and three times weekly swallowing exercises by physio- and occupational therapists, respectively, as well as daily home exercises throughout radiotherapy or (2) standard care. Inclusion criteria are patients with cancer in the larynx, pharynx, oral cavity, or unknown primary tumor who are referred to radiotherapy with curative intent. Outcomes are measured at end-of-treatment and two, five, and 12 months post-treatment. Interim results: In 16 months, 321 HNC patients were screened for eligibility. Of these, 131 (41%) were eligible according to inclusion criteria. One-hundred-and-fifteen patients were invited to participate of which 69 (60%) were enrolled in the trial and randomized for either intervention or control group with 10 drop-outs (14%). The six pilot patients adhered more than 90% to the program. CONCLUSION: Preliminary results show that exercise according to protocol is tolerable and feasible.

Association between late effects assessed by physicians and quality of life reported by head-and-neck cancer survivors.

BACKGROUND: Many survivors of head-and-neck cancer (HNC) suffer from late effects. Their overall quality of life deteriorates during treatment, followed by a slow recovery up to five years after treatment. We examined the association between the severity of physician-assessed late effects and the health-related quality of life (HRQoL) reported by survivors of HNC. MATERIAL AND METHODS: The analysis was based on data collected during follow-up for 136 survivors of cancer in the oral cavity, pharynx, larynx, or salivary glands. Physicians' assessments of dysphagia, xerostomia, fibrosis, and hoarseness, derived from reports to of the Danish Head and Neck Cancer Group database and patient-reported overall quality of life and social, role, emotional, cognitive, and physical functioning reported on the European Organization for Research and Treatment of Cancer questionnaire. Linear regression models were used to examine the association between the severity of each late effect and HRQoL. RESULTS: Quality of life was decreased among patients with moderate to severe dysphagia compared to patients without dysphagia (-16 points; 95% CI -21;-3). Also role functioning (-20 points; 95% CI -38;-2), emotional functioning (-19 points; 95% CI -34;-4) and social functioning (-27 points; 95% CI -41;-13) decreased compared with patients without dysphagia. Mild dysphagia was also associated with decreased overall quality of life (-12 points; 95% CI -21;-3). Moderate to severe hoarseness was significantly associated with poorer social functioning (-25 points; 95% CI -41;-10). There was no association between fibrosis or xerostomia and HRQoL. CONCLUSION: Physician-assessed moderate to severe hoarseness and mild, moderate, or severe dysphagia are associated with clinically relevant decreases in patient-reported quality of life and functioning. Fibrosis and xerostomia of any severity were not associated with changes in any scale of functioning in this study population.

Preoperative modifiable risk factors in colorectal surgery: an observational cohort study identifying the possible value of prehabilitation.

BACKGROUND: Colorectal cancer (CRC) is the second most prevalent type of cancer in the world. Surgery is the most common therapeutic intervention, and associated with 20-40% reduction in physiological and functional capacity. Postoperative complications occur in up to 50% of patients resulting in higher mortality rates and greater hospital costs. The number and severity of complications is closely related to patients' preoperative performance status. The aim of this study was to identify the most important preoperative modifiable risk factors that could be part of a multimodal prehabilitation program. METHODS: Prospectively collected data of a consecutive series of Dutch CRC patients undergoing colorectal surgery were analyzed. Modifiable risk factors were correlated to the Comprehensive Complication Index (CCI) and compared within two groups: none or mild complications (CCI <20), and severe complications (CCI ≥20). Multivariate logistic regression analysis was done to explore the combined effect of individual risk factors. RESULTS: In this 139 patient cohort, smoking, malnutrition, alcohol consumption, neoadjuvant therapy, higher age, and male sex, were seen more frequently in the severe complications group (CCI ≥20). Patients with severe complications had significantly longer hospital stay (16 vs. 6 days, p < 0.001). The risk for severe complications was increased in patients with ASA score III [adjusted odds ratio (OR) 4.4, 95% CI 1.04-18.6], and hemoglobin level <7 mmol/l (adjusted OR 3.3, 95% CI 1.3-8.2). Compared to having no risk factors, more than one risk factor increased OR of severe complications (crude OR 5.2, 95% CI 1.8-15). CONCLUSION: This study revealed that the risk of getting severe complications increases with the number of risk factors present preoperatively. Several preoperative patient-related risk factors are modifiable. Multimodal prehabilitation may improve patients' preoperative status and should be tested in a multicenter randomized controlled trial. With an international consortium (Copenhagen, Montreal, Paris, Eindhoven) we initiated a randomized controlled trial (NTR5947).