Follow-up Schedule for Patients With Sentinel Node-negative Cutaneous Melanoma (The MELFO Study): An International Phase III Randomized Clinical Trial.

OBJECTIVES AND DESIGN: The MELFO (MELanoma FOllow-up) study is an international phase III randomized controlled trial comparing an experimental low-intensity schedule against current national guidelines. BACKGROUND: Evidence-based guidelines for the follow-up of sentinel node-negative melanoma patients are lacking. METHODS: Overall, 388 adult patients diagnosed with sentinel node-negative primary melanoma patients were randomized in cancer centers in the Netherlands and United Kingdom between 2006 and 2016. The conventional schedule group (control: n=196) was reviewed as per current national guidelines. The experimental schedule group (n=192) was reviewed in a reduced-frequency schedule. Quality of life was the primary outcome measurement. Detection rates and survival outcomes were recorded. Patient satisfaction rates and compliance with allocated schedules were compared. RESULTS: At 5 years, both arms expressed high satisfaction with their regimens (>97%). This study found no significant group effect on any patient-reported outcome measure scores between the follow-up protocols. In total, 75/388 (19.4%) patients recurred, with no difference in incidence found between the 2 arms (hazard ratio=0.87, 95% confidence interval: 0.54-1.39, P =0.57). Self-examination was the method of detection for 25 experimental patients and 32 control patients (75.8% vs. 76.2%; P =0.41). This study found no difference in any survival outcomes between the 2 study arms (disease-free survival: hazard ratio=1.00, 95% confidence interval: 0.49-2.07, P =0.99). CONCLUSIONS: A reduced-intensity, American Joint Committee on Cancer (AJCC) stage-adjusted follow-up schedule for sentinel node-negative melanoma patients is a safe strategy, and patient self-examination is effective for recurrence detection with no evidence of diagnostic delay. Patients' acceptance is very high.

Obesity is not associated with disease-free interval, melanoma-specific survival, or overall survival in patients with clinical stage IB-II melanoma after SLNB.

BACKGROUND AND OBJECTIVES: Clinicopathologic characteristics have prognostic value in clinical stage IB-II patients with melanoma. Little is known about the prognostic value of obesity that has been associated with an increased risk for several cancer types and worsened prognosis after diagnosis. This study aims to examine effects of obesity on outcome in patients with clinical stage IB-II melanoma. METHODS: Prospectively recorded data of patients with clinical stage IB-II melanoma who underwent sentinel lymph node biopsy (SLNB) between 1995 and 2018 at the University Medical Center of Groningen were collected from medical files and retrospectively analyzed. Cox-regression analyses were used to determine associations between obesity (body mass index> 30), tumor (location, histology, Breslow-thickness, ulceration, mitotic rate, SLN-status) and patient-related variables (gender, age, and social-economic-status [SES]) and disease-free interval (DFI), melanoma-specific survival (MSS), and overall survival (OS). RESULTS: Of the 715 patients, 355 (49.7%) were women, median age was 55 (range 18.6-89) years, 149 (20.8%) were obese. Obesity did not significantly affect DFI (adjusted hazard ratio [HR] = 1.40; 95% confidence interval [CI] = 0.98-2.00; p = 0.06), MSS (adjusted HR = 1.48;95%CI = 0.97-2.25; p = 0.07), and OS (adjusted HR = 1.25; 95% CI = 0.85-1.85; p = 0.25). Increased age, arm location, increased Breslow-thickness, ulceration, increased mitotic rate, and positive SLN-status were significantly associated with decreased DFI, MSS, and OS. Histology, sex, and SES were not associated. CONCLUSION: Obesity was not associated with DFI, MSS, or OS in patients with clinical stage IB-II melanoma who underwent SLNB.

The MelFo Study UK: Effects of a Reduced-Frequency, Stage-Adjusted Follow-Up Schedule for Cutaneous Melanoma 1B to 2C Patients After 3-Years.

BACKGROUND: Evidence-based guidelines for follow-up treatment of American Joint Committee on Cancer (AJCC) stages 1B to 2C melanoma patients are lacking. The MELanoma FOllow-up study is an international phase 3 randomized trial, and the 3-year interim data were recently reported from the Netherlands. The study was undertaken concurrently with a British cohort for comparison and validation of the Dutch study. METHODS: The study enrolled and stratified 207 patients by AJCC stage. The conventional schedule group (CSG; n = 103) cohort was reviewed as per UK guidelines. The experimental schedule group (ESG; n = 104) cohort was reviewed in a reduced-frequency nurse-led, consultant-supervised clinic. Quality of life (QoL) was measured at baseline (T1), a 1 year (T2), and at 3 years (T3) using the State-Trait Anxiety Inventory, the Cancer Worry Scale, the Impact-of-Event Scale, and the Mental and Physical Component scales (PCS/MCS) of the RAND-36. RESULTS: Of the 207 QoL questionnaires, 170 (82.1%) were completed at T3. Both cohorts expressed high satisfaction (> 93%) with their regimens. At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols. Recurrence had developed in 33 patients Conventional follow-up (CFU), 16 [15.5%]; Experimental follow-up (EFU), 17 [16.3%]. Self-examination was the method of detection for 12 ESG patients (70.6%) and 11 CSG patients (68.8%). The melanoma-specific survival was identical. CONCLUSION: The UK 3-year data were consistent with the previous Dutch report. The reduced follow-up strategy was shown to be safe, with significant resource usage benefits for national cancer services. Patient anxiety levels were not increased by a less-intensive follow-up regimen, and acceptance was high. The study data indicate that patient self-examination is very effective for recurrence detection.

The MELFO Study: A Multicenter, Prospective, Randomized Clinical Trial on the Effects of a Reduced Stage-Adjusted Follow-Up Schedule on Cutaneous Melanoma IB-IIC Patients-Results After 3 Years.

BACKGROUND: This study compares well-being, recurrences, and deaths of early-stage cutaneous melanoma patients in follow-up, as recommended in the Dutch guideline, with that of patients in a stage-adjusted reduced follow-up schedule, 3 years after diagnosis, as well as costs. METHODS: Overall, 180 eligible pathological American Joint Committee on Cancer (AJCC) stage IB-IIC, sentinel node staged, melanoma patients (response rate = 87%, 48% male, median age 57 years), randomized into a conventional (CSG, n = 93) or experimental (ESG, n = 87) follow-up schedule group, completed patient-reported outcome measures (PROMs) at diagnosis (T1): State-Trait Anxiety Inventory-State version (STAI-S), Cancer Worry Scale (CWS), Impact of Event Scale (IES), and RAND-36 (Mental and Physical Component scales [PCS/MCS]). Three years later (T3), 110 patients (CSG, n = 56; ESG, n = 54) completed PROMs, while 42 declined (23%). RESULTS: Repeated measures analyses of variance (ANOVAs) showed a significant group effect on the IES (p = 0.001) in favor of the ESG, and on the RAND-36 PCS (p = 0.02) favoring the CSG. Mean IES and CWS scores decreased significantly over time, while those on the RAND-36 MCS and PCS increased. Effect sizes were small. Twenty-five patients developed a recurrence or second primary melanoma, of whom 13 patients died within 3 years. Cox proportional hazards models showed no differences between groups in recurrence-free survival (hazard ratio [HR] 0.71 [0.32-1.58]; p = 0.400) and disease-free survival (HR 1.24 [0.42-3.71]; p = 0.690). Costs per patient after 3 years (computed for 77.3% of patients) were 39% lower in the ESG. CONCLUSION: These results seemingly support the notion that a stage-adjusted reduced follow-up schedule forms an appropriate, safe, and cost-effective alternative for pathological AJCC stage IB-IIC melanoma patients to the follow-up regimen as advised in the current melanoma guideline.

Effects on patient-reported outcomes of "Screening of Distress and Referral Need" implemented in Dutch oncology practice.

PURPOSE: This study investigated the effect of the "Screening for Distress and Referral Need" (SDRN) process (completing a screening instrument; patient-caregiver discussion about the patient's responses, regardless of distress level, and possible referral to specialized care), implemented in Dutch oncology practice on patient-reported outcomes (PROs). METHODS: A non-randomized time-sequential study was conducted to compare two cohorts. Cohort 1 respondents (C1) were recruited before and cohort 2 respondents (C2) after SDRN implementation in nine Dutch hospitals. Participants completed the EORTC-QLQ-C30, HADS, Patient Satisfaction Questionnaire-III, and the Distress Thermometer and Problem List (DT&PL). Descriptive analyses and univariate tests were conducted. RESULTS: C2 respondents (N = 422, response = 54%) had significantly lower mean scores on the practical (t = 2.3; p = 0.02), social (t = 2.3; p = 0.03), and emotional PL domains (t = 2.9; p = 0.004) compared with C1 (N = 518, response = 53%). No significant differences were found on quality of life, anxiety, depression, satisfaction with care, distress level, the spiritual and physical PL domains, or on referral wish. CONCLUSIONS: After implementation of SDRN, patients report significantly fewer psychosocial (practical, social, and emotional) problems on the DT/PL but responses on the other patient-reported outcomes were comparable. These results add to the mixed evidence on the beneficial effect of distress screening. More and better focused research is needed.

Cancer patients' experiences with and opinions on the process 'Screening of Distress and Referral Need' (SDRN) in clinical practice: A quantitative observational clinical study.

OBJECTIVE: This observational clinical study investigated patients' experiences with and opinions on the Dutch 'Screening of Distress and Referral Need' (SDRN) process implemented in oncology practice. Insight into these can guide improvement of the SDRN process. METHODS: Patients from hospitals that had implemented SDRN for at least a year completed questions on experiences with essential SDRN process steps (1: completion of the Distress Thermometer and Problem List as screening instrument (DT&PL), 2: information on SDRN+DT&PL, 3: information on referral options, 4: discussing DT&PL responses, 5: referral when needed), and on opinions about SDRN and DT&PL. Descriptive and univariate analyses were conducted. RESULTS: Of the 498 participants (response = 54%), 81% completed a DT&PL, of whom 86-87% was exposed to steps 2-3 and 76% discussed responses; only three needing care were not offered referral. Sixty-one percent encountered all SDRN steps and 78% would recommend SDRN to others. Recommending SDRN is related to more frequent DT&PL completion (t = -2.5; p≤0.01), receipt of information on SDRN+DT&PL and referral options (X2 = 4.9; p≤0.05 and X2 = 5.9; p≤0.05 respectively), discussion of responses (X2 = 10.2; p≤0.001), and fuller exposure to SDRN process steps (X2 = 14.8; p≤0.01). Percentages (strongly) agreeing were highest on the DT&PL being useful (90%) and suitable (88%), and lowest on burdensome (31%) and time-consuming (28%). CONCLUSION: The majority of participating patients encountered the steps of the SDRN process considered essential, with 3/5 having encountered all steps. Referral is largely targeted to patients' need. Patients' perceived benefit of SDRN increases with fuller exposure to all process steps. Therefore, improvements, particularly in DT&PL completion and discussion of responses should be made.

Validation of the Distress Thermometer and Problem List in Patients with Recurrent Respiratory Papillomatosis.

Objective There is no specific clinical tool for physicians to detect psychosocial and physical distress or health care need in patients with recurrent respiratory papillomatosis (RRP). The main aim of this study is to validate the RRP-adapted Distress Thermometer and Problem List (DT&PL). Study Design Prospective cross-sectional questionnaire research. Setting Academic tertiary care medical centers in Groningen, Netherlands, and Helsinki, Finland. Subjects and Methods Ninety-one juvenile- and adult-onset RRP patients participated from the departments of otorhinolaryngology-head and neck surgery of the University Medical Center Groningen, Netherlands, and Helsinki University Hospital, Finland. The Hospital Anxiety and Depression Scale was used as the gold standard. Results A DT cutoff score ≥4 gave the best sensitivity and specificity. Thirty-one percent of patients had significant distress according to the DT cutoff. Significantly more patients with a score above than under the cutoff had a referral wish. The PL appeared to be reliable. Patients' opinions on the DT&PL were largely favorable. Conclusion The Dutch and Finnish versions of the DT&PL are valid, reliable screening tools for distress in RRP patients.

Quality of life of patients with recurrent respiratory papillomatosis.

OBJECTIVES/HYPOTHESIS: Recurrent respiratory papillomatosis (RRP) is a disease with a high disease burden. Few studies have assessed quality of life (QoL) of RRP patients. This study compares QoL of these patients with controls. Associations between QoL and sociodemographic and illness-related factors are examined, as is uptake of psychosocial care and speech therapy. STUDY DESIGN: Prospective cross-sectional questionnaire research. METHODS: Ninety-one RRP patients (response = 67%) from two university hospitals in the Netherlands and Finland completed the following patient reported outcome measures: (HADS), 15-dimensional health-related quality-of-life scale (15D), Voice Handicap Index (VHI) and the RAND 36-item health-related quality-of-life survey instrument (RAND-36) assessing health-related QoL and voice handicap, and they provided sociodemographic, illness-related, and allied healthcare use. Descriptive analyses, χ2 tests, t tests, analysis of variance tests, and Pearson correlations were computed to describe the study population and to examine differences between groups. RESULTS: RRP patients had significantly higher mean scores on depression, health-related QoL (15D) and on voice problems (VHI), and significantly lower mean scores on anxiety than controls. Dutch patients had more pain and a decreased general health perception (RAND-36) than controls. Dutch patients and older patients were more depressed, women were more anxious, older patients had lower health-related QoL, and smoking was significantly associated with voice handicap. Patients who had received psychosocial care had significantly higher HADS-depression mean scores than patients who did not receive psychosocial care. CONCLUSIONS: Having RRP has significant effect on voice-related QoL and depression, but has no negative effect on anxiety and health-related QoL. Risk factors for decreased functioning are different than previously hypothesized by many authors. Prevention should be aimed at these risk factors. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:1826-1831, 2017.

The MELFO-Study: Prospective, Randomized, Clinical Trial for the Evaluation of a Stage-adjusted Reduced Follow-up Schedule in Cutaneous Melanoma Patients-Results after 1 Year.

BACKGROUND: Guidelines for evidence-based follow-up in melanoma patients are not available. This study examined whether a reduced follow-up schedule affects: patient-reported outcome measures, detection of recurrences, and follow-up costs. METHODS: This multicenter trial included 180 patients treated for AJCC stage IB-II cutaneous melanoma, who were randomized in a conventional follow-up schedule group (CSG, 4 visits first year, n = 93) or experimental follow-up schedule group (ESG, 1-3 visits first year, n = 87). Patients completed the State-Trait Anxiety Inventory, cancer worry scale, impact of events scale, and a health-related quality of life questionnaire (HRQoL, RAND-36). Physicians registered clinicopathologic features and the number of outpatient clinic visits. RESULTS: Sociodemographic and illness-related characteristics were equal in both groups. After 1-year follow-up, the ESG reported significantly less cancer-related stress response symptoms than the CSG (p = 0.01), and comparable anxiety, mental HRQoL, and cancer-related worry. Mean cancer-related worry and stress response symptoms decreased over time (p < 0.001), whereas mental HRQoL increased over time (p < 0.001) in all melanoma patients. Recurrence rate was 9 % in both groups, mostly patient-detected and not physician-detected (CSG 63 %, ESG 43 %, p = 0.45). Hospital costs of 1-year follow-up were reduced by 45 % in the ESG compared to the CSG. CONCLUSIONS: This study shows that the stage-adjusted, reduced follow-up schedule did not negatively affect melanoma patients' mental well-being and the detection of recurrences compared with conventional follow-up as dictated by the Dutch guideline, at 1 year after diagnosis. Additionally, reduced follow-up was associated with significant hospital cost reduction.

Overall Quality of Life in Adult Biliary Atresia Survivors with or without Liver Transplantation: Results from a National Cohort.

Background Biliary atresia (BA) is a rare cholestatic disease of infancy. Kasai portoenterostomy and liver transplantation (LT) are the two sequential treatment options. An increasing number of patients survive into adulthood. Little is known about their health-related quality of life (HRQOL). This study aims to compare HRQOL of transplanted and nontransplanted patients in a cohort of young adult BA survivors. Patients and Methods RAND-36 and Liver Disease Index Score (LDSI) questionnaires were sent to eligible adult patients with BA. Clinical characteristics were obtained from the NeSBAR (Netherlands Study group on Biliary Atresia Registry) and the national pediatric LT database. RAND-36 domain and summary scores were compared with those of an age-matched Dutch reference group. The correlations between several clinical variables and HRQOL were analyzed. Results Mean RAND-36 domain and summary scores of transplanted (n = 15) and nontransplanted (n = 25) patients with BA (response 74%) were similar to the reference scores, with the exception of a decreased general health perception in nontransplanted patients (63 ± 21 vs. 75 ± 17; [p < 0.001], particularly in females. RAND-36 domain and summary scores were not significantly correlated to age at LT, time since LT, serum bilirubin, aspartate amino transferase or albumin levels, but were moderately to strongly correlated to LDSI total scores (r values 0.35-0.77). Conclusions Overall, young adult patients with BA have a HRQOL similar to an age-matched reference group. However, general health perception of nontransplanted patients, particularly of females, was decreased. HRQOL is correlated to liver disease symptoms but not to liver biochemistry parameters. Nontransplanted females and patients suffering from liver disease-associated symptoms may be a target for tailored supportive interventions.

Delay in Diagnosis of Testicular Cancer; A Need for Awareness Programs.

BACKGROUND AIM: To gain insight into patient and doctor delay in testicular cancer (TC) and factors associated with delay. MATERIALS AND METHODS: Sixty of the 66 eligible men; median age 26 (range 17-45) years, diagnosed with TC at the University Medical Center Groningen completed a questionnaire on patients' delay: interval from symptom onset to first consultation with a general practitioner (GP) and doctors' delay: interval between GP and specialist visit. RESULTS: Median patient reported delay was 30 (range 1-365) days. Patient delay and TC tumor stage were associated (p = .01). Lower educated men and men embarrassed about their scrotal change reported longer patient delay (r = -.25, r = .79 respectively). Age, marital status, TC awareness, warning signals, nor perceived limitations were associated with patient delay. Median patient reported time from GP to specialist (doctors' delay) was 7 (range 0-240) days. Referral time and disease stage were associated (p = .04). Six patients never reported a scrotal change. Of the 54 patients reporting a testicular change, 29 (54%) patients were initially 'misdiagnosed', leading to a median doctors' delay of 14 (1-240) days, which was longer (p< .001) than in the 25 (46%) patients whose GP suspected TC (median doctors' delay 1(0-7 days). CONCLUSIONS: High variation in patients' and doctors' delay was found. Most important risk variables for longer patient delay were embarrassment and lower education. Most important risk variable in GP's was 'misdiagnosis'. TC awareness programs for men and physicians are required to decrease delay in the diagnosis of TC and improve disease free survival.

Moderators of the effects of group-based physical exercise on cancer survivors' quality of life.

PURPOSE: This study explored demographic, clinical, and psychological moderators of the effect of a group-based physical exercise intervention on global quality of life (QoL) among cancer survivors who completed treatment. METHODS: Cancer survivors were assigned to a 12-week physical exercise (n = 147) or a wait-list control group (n = 62). The main outcome measure was global QoL, assessed with the EORTC QLQ-C30 at baseline and 12 weeks later. Potential moderators were age, gender, education level, marital status, employment status, type of treatment, time since treatment, the presence of comorbidities, fatigue, general self-efficacy, depression, and anxiety. Linear regression analyses were used to test effect modification of the intervention by each moderator variable using interaction tests (p ≤ 0.10). RESULTS: The physical exercise intervention effect on global QoL was larger for cancer survivors who received radiotherapy (ß = 10.3, 95 % confidence interval (CI) = 4.4; 16.2) than for cancer survivors who did not receive radiotherapy (ß = 1.8, 95 % CI = -5.9; 9.5, p interaction = 0.10), larger for cancer survivors who received a combination of chemoradiotherapy (ß = 13.0, 95 % CI = 6.0; 20.1) than for those who did not receive this combination of treatments (ß = 2.5, 95 % CI = -3.7; 8.7, p interaction = 0.02), and larger for cancer survivors with higher baseline levels of fatigue (ß = 12.6, 95 % CI = 5.7; 19.6) than for those with lower levels (ß = 2.4, 95 % CI = -3.9; 8.7, p interaction = 0.03). No other moderating effects were found. CONCLUSIONS: This study suggests that cancer treatment modality and baseline fatigue levels moderate the effect of a physical exercise program on cancer survivors'global QoL.

Effects of communication styles on marital satisfaction and distress of parents of pediatric cancer patients: a prospective longitudinal study.

OBJECTIVE: The aim of this study was to examine the longitudinal effects of communication styles on marital satisfaction and distress of parents of children treated for cancer. METHODS: Marital dissatisfaction (Maudsley Marital Questionnaire), intimacy, avoidance, destructive and incongruent communication (Communication Skills Inventory) and psychological distress (General Health Questionnaire) were assessed in 115 parents of pediatric cancer patients shortly after diagnosis (T1) and 5 years later (T2). RESULTS: Only mothers' marital dissatisfaction increased significantly over time. No gender differences in dissatisfaction were found. Mothers had a significantly higher lack of intimacy score than fathers. All T1 communication styles were significantly univariately related to fathers' and mothers' T2 marital dissatisfaction, while not to T2 distress. Mothers' T1 marital dissatisfaction accounted for 67% and fathers' for 12% in the explained variance of T2 dissatisfaction. T1 destructive communication uniquely affected fathers' T2 marital dissatisfaction and T1 avoidant communication that of mothers. CONCLUSIONS: Five years after cancer diagnosis in their children, the quality of parents' marital relationships seemed largely unchanged. Parents' use of communication skills at diagnosis appeared to have limited effect on their marital dissatisfaction and no effect on their distress 5 years later. While avoidant communication seemed indicative of mothers' marital distress, fathers' seemed affected by destructive communication.

Health status and quality of life in adult biliary atresia patients surviving with their native livers.

INTRODUCTION: Gaining an insight into the quality of life (QOL) in long-term biliary atresia (BA) survivors is becoming more important. Identifying patients with limitations might make tailor made interventions possible. This is the first study investigating the health status (HS) and QOL in adults surviving BA with their native livers, and comparing them with healthy peers. METHODS: BA patients surviving with their native liver were identified in the Netherlands Study Group on Biliary Atresia Registry database. The RAND-36 and the World Health Organization Quality of Life assessment instrument-100 (WHOQOL-100) were used to measure HS and QOL, respectively. Correlation between the RAND-36 and WHOQOL-100 was also assessed. Hospital Anxiety and Depression Scale (HADS) and the Impact Event Scale (IES) were also completed. RESULTS: In total, 25 (83%) of the 30 eligible patients after Kasai portoenterostomy completed the questionnaires (median age 23.2 years). A lower perceived level of general health in HS was found as compared with the reference group and a higher score on the social domain was reported in QOL. Correlations between HS and QOL questionnaires were moderate to good. For the group, overall HADS and IES scores were good, though individual patients did score above the cutoff of both the questionnaires. CONCLUSION: Adult BA patients surviving with their native liver have similar HS and QOL as compared with their healthy peers. RAND-36 and WHOQOL-100 questionnaires are not interchangeable, but complementary to assess the patients' outcomes. The overall scores did not point to increased levels of anxiety and depression. However, on an individual level, three and six patients had a score above the cutoff of the HADS subscales demonstrating clinically relevant levels of anxiety and depression, respectively.

A prospective study of cognitive function in men with non-seminomatous germ cell tumors.

OBJECTIVE: Longitudinal neuropsychological assessments were performed to determine if adjuvant chemotherapy was associated with cognitive dysfunction in men with non-seminomatous germ cell tumors (NSGCT). METHODS: Patients with NSGCT status post-orchiectomy that either received adjuvant chemotherapy (n = 55) or did not (n = 14) were recruited. Patients were tested before chemotherapy, 1 week post-chemotherapy (or 3 months later in the surveillance group) and 12 months after the baseline evaluation. RESULTS: Compared with the surveillance group, patients treated with chemotherapy had higher rates of cognitive decline at 12 months (overall cognitive decline: 0%, 52%, and 67% in the surveillance, low exposure (LE), and high exposure (HE) group, respectively), greater number of tests that declined (mean of 0.1, 1.4, and 2.0 in the surveillance, LE, and HE group, respectively), and more frequent worsening in motor dexterity (0%, 48%, and 46% in the surveillance, LE, and HE group, respectively). Compared with the surveillance group, patients receiving more cycles of chemotherapy demonstrated worse psychomotor speed and learning and memory. Younger age was associated with greater incidence of overall cognitive decline at 12-month follow-up. CONCLUSIONS: Men with NSGCT that received chemotherapy demonstrated greater rates of cognitive decline in a dose-response manner. Reductions in motor dexterity were most common. Decline in learning and memory also was evident particularly at later follow-up time points and in men receiving more chemotherapy. Men that receive chemotherapy for NSGCT are at risk for cognitive decline and may benefit from monitoring and referral for psychosocial care.

A longitudinal study of shoulder and arm morbidity in breast cancer survivors 7 years after sentinel lymph node biopsy or axillary lymph node dissection.

Knowledge about long-term consequences of breast cancer treatment on shoulder and arm function and volume in stages I-II breast cancer survivors is limited. The effects of shoulder-arm function shortly after surgery on long-term function are unknown. One hundred and ninety-four women were examined pre-surgery (T0) and 6 weeks after surgery (T1). Of those, 110 were re-examined 7 years later (T2). Thirty-four women underwent sentinel lymph node biopsy (SLNB) and 76 underwent axillary lymph node dissection (ALND). Differences between affected and unaffected side were calculated for four ranges of motion functions, three strength functions and arm volume. These were used to analyse time and group effects. Differences exceeding 20° in range of motion, 20 % in strength and 200 ml in arm volume were considered clinically relevant. Multivariate regression analyses examined the effect of shoulder-arm function at T1 on shoulder-arm function at T2. Additional predictor variables included were age, follow-up time, Body Mass Index, complications, chemotherapy, radiation, SLNB/ALND and type of breast surgery. At T2, range of motion (except external rotation), abduction strength and arm volume were impaired compared to T0. After ALND, women had significantly more forward flexion impairment, increased arm volume and clinically relevant impairments (70 %) than after SLNB (41 %). T1 external rotation, abduction-external rotation, grip strength and arm volume were the strongest predictors of these variables at T2. Age was the strongest predictor of the remaining four variables. ALND predicted arm volume only. Seven years after breast cancer surgery, two-fifth of the women after SLNB and seven out of ten women after ALND had impairments. Impairments were found in five of eight shoulder-arm functions. After SLNB, women have less forward flexion impairment and less arm volume increase than after ALND. Shoulder-arm function at 6 weeks after surgery and age are the strongest predictors of long-term shoulder-arm function.

Impact of the European Randomized Study of Screening for Prostate Cancer (ERSPC) on prostate-specific antigen (PSA) testing by Dutch general practitioners.

OBJECTIVE: To determine the impact of the European Randomized Study of Screening for Prostate Cancer (ERSPC) publication in 2009 on prostate-specific antigen (PSA) level testing by Dutch general practitioners (GPs) in men aged ≥40 years. MATERIALS AND METHODS: Retrospective study with a Dutch insurance company database (containing PSA test claims) and a large district hospital-laboratory database (containing PSA-test results). The difference in primary PSA-testing rate as well as follow-up testing before and after the ERSPC was tested using the chi-square test with statistical significance at P < 0.05. RESULTS: Decline in PSA tests 4 months after ERSPC publication, especially for men aged ≥60 years. Primary testing as well as follow-up testing decreased, both for PSA levels of <4 ng/mL as well as for PSA levels of 4-10 ng/mL. Follow-up testing after a PSA level result of >10 ng/mL moderately increased (P = 0.171). Referral to a urologist after a PSA level result of >4 ng/mL decreased slightly after the ERSPC publication (P = 0.044). CONCLUSIONS: After the ERSPC publication primary PSA testing as well as follow-up testing decreased. Follow-up testing seemed not to be adequate after an abnormal PSA result. The reasons for this remain unclear.