Screening versus multidimensional assessment of symptoms and psychosocial distress in cancer patients from the time of incurability.

Objective: Previous symptom prevalence studies show a diverse spectrum of symptoms and a large diversity in symptom intensities in patients being just diagnosed as having incurable cancer. It is unclear, how physical symptoms and psychosocial burden should be recorded in order to determine the variable need for palliative care and further support. Therefore, we compared two different strategies for detecting physical symptoms and psychosocial burden of patients with newly diagnosed incurable cancer and their effects on the further course of the disease. Methods: SCREBEL is a controlled, randomized, non-blinded, longitudinal study of the research network of the Palliative Medicine Working Group (APM) of the German Cancer Society (DKG). We compared: a less complex repeated brief screening for symptoms and burden in patients using the NCCN Distress Thermometer and IPOS questionnaire versus a multidimensional comprehensive assessment using the FACT-G and their entity-specific questionnaires, the PHQ4 scales, SCNS-34-SF, IPOS and NCCN Distress Thermometer. The primary study endpoint was quality of life (QoL), measured using FACT-G, after six months. Secondary study endpoints were QoL by using evaluation of secondary scores (NCCN DT, IPOS, PHQ4, SCNS-SF-34G) at time 6 months, the number of hospital days, the utilization of palliative care, emergency services, and psychosocial care structures. To assess effects and differences, multiple linear regression models were fitted and survival analyses were conducted. Results: 504 patients were included in the study. 262 patients were lost to follow-up, including 155 fatalities. There were no significant differences between the low-threshold screening approach and a comprehensive assessment with respect to symptoms and other aspects of QoL. Using the IPOS, we were able to measure an improvement in the quality of life in the low-threshold screening arm by a decrease of 0.67 points (95%-CI: 0.34 to 0.99) every 30 days. (p<0.001). Data on the involvement of emergency facilities and on supportive services were insufficient for analysis. Conclusion: A comprehensive, multidimensional assessment did not significantly differ from brief screening in preserving several dimensions of quality of life. These findings may positively influence the implementation of structured low-threshold screening programs for supportive and palliative needs in DKG certified cancer centers.DRKS -No. DRKS00017774 https://drks.de/search/de/trial/DRKS00017774.

[Support for and involvement of family caregivers in Comprehensive Cancer Center - an Assessment of the Palliative Care Working Group within the network of Comprehensive Cancer Center funded by the German Cancer Aid]. / Mitbetreuung und Einbeziehung von Angehörigen in Comprehensive Cancer Centern ­ eine Erhebung der AG Palliativmedizin der von der Deutschen Krebshilfe geförderten Onkologischen Spitzenzentren.

BACKGROUND: According to current oncological guidelines, early integration of specialist palliative care (SPC) represents standard cancer care supporting not only the patients, but also their family caregivers. Data on the actual implementation in daily oncology practice in Germany are lacking. METHODS: The Palliative Care Working Group of the network of Comprehensive Cancer Centers certified by the German Cancer Aid (CCC) assessed the implementation of measures for family caregiver support and involvement within the CCC/within SPC in the CCC/local outside the CCC in all 17 CCC locations. RESULTS: In the CCC/in SPC psycho-oncological (100 %/94 %), social (94 %/100 %) and spiritual counselling of family caregivers (94 % each) as well as support for children with parental cancer (88 %/100 %) and information materials for family caregivers (88 % each) are well established. Training on nursing skills (77 %/94 %) and family conferences (59 %/88 %) are established more frequently within SPC than in the rest of the CCC. SOPs are rather rare (23 %/18 %) as well as screenings for family caregiver needs (0/24 %). Bereavement or self-help groups are with 82 % each more frequent locally outside the CCC. Psycho-oncological and social counselling as well as support for children with parental cancer were scored as most important (94 % each). For SPC, training on nursing skills and information materials were rated equally (94 % each). SOPs were rated as very/extremely important in 47 %/41 % and routine screening for family caregiver in 53 %/65 %. CONCLUSION: In correspondence to their importance, psychosocial and spiritual counselling and support for children with parental cancer are well implemented in CCC. In SPC, training on nursing skills and family conferences are also well implemented. SOPs for family caregiver support and involvement as well as routine screenings for family caregiver needs have to be implemented urgently in the CCC.

Management of Germ Cell Tumours of the Testis in Adult Patients. German Clinical Practice Guideline Part I: Epidemiology, Classification, Diagnosis, Prognosis, Fertility Preservation, and Treatment Recommendations for Localized Stages.

INTRODUCTION: This is the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up on germ cell tumours (GCTs) of the testis in adult patients. We present the guideline content in two publications. Part I covers the topic's background, methods, epidemiology, classification systems, diagnostics, prognosis, and treatment recommendations for the localized stages. METHODS: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search was in March 2018) were provided. Thirty-one experts entitled to vote, rated the final clinical recommendations and statements. RESULTS: We provide 161 clinical recommendations and statements. We present information on the quality of cancer care and epidemiology and give recommendations for staging and classification as well as for diagnostic procedures. The diagnostic recommendations encompass measures for assessing the primary tumour as well as procedures for the detection of metastases. One chapter addresses prognostic factors. In part I, we separately present the treatment recommendations for germ cell neoplasia in situ, and the organ-confined stages (clinical stage I) of both seminoma and nonseminoma. CONCLUSION: Although GCT is a rare tumour entity with excellent survival rates for the localized stages, its management requires an interdisciplinary approach, including several clinical experts. Quality of care is highly related to institutional expertise and can be reassured by established online-based second-opinion boards. There are very few studies on diagnostics with good level of evidence. Treatment of metastatic GCTs must be tailored to the risk according to the International Germ Cell Cancer Collaboration Group classification after careful diagnostic evaluation. An interdisciplinary approach as well as the referral of selected patients to centres with proven experience can help achieve favourable clinical outcomes.

Individual specialist physical activity assessment and intervention in advanced cancer patients on a palliative care ward; the 3STEPS-study.

The aim of this prospective study was to evaluate the feasibility and outcome of an activity assessment and intervention on a specialized palliative care ward. All patients admitted between May 2017 and April 2018 were screened for basic assessment (Step 1). Whenever possible the Tinetti-mobility test (TT) was performed by a physiotherapist. A comparison between physician and nurse-led assessment and patient report was performed (Step 2), followed by a low-intensity individually adapted activity intervention (Step 3). Physical function and global quality of life was measured at intervention start and at discharge. Home care training adherence was controlled by phone call. In total, 437 patients were admitted in one year. In 248 patients, a basic assessment was done of which 131 performed a TT. In this group, median age was 63 years. Types of cancer were gastrointestinal (n=39), lung (n=27), urogenital (n=20), non-cancer (n=26) and other (n=26). Median length of stay was 13 days. Correlations between assessment methods were low to moderate, the highest between the TT and the nurse led assessment. Six patients started the intervention. Four patients completed the intervention, of which two continued with the home based training. In all four patients, an improvement in outcomes was measured. In conclusion in around a quarter of patients on a palliative care ward a TT could be performed. The TT correlated to most with nurse led mobility assessment. In the few accrued patients, the activity intervention showed an effect.

Systematic symptom and problem assessment at admission to the palliative care ward - perspectives and prognostic impacts.

BACKGROUND: Symptom assessment is essential in palliative care, but holds challenges concerning implementation and relevance. This study aims to evaluate patients' main symptoms and problems at admission to a specialist inpatient palliative care (SIPC) ward using physician proxy- and patient self-assessment, and aims to identify their prognostic impact as well as the agreement between both assessments. METHODS: Within 12 h after admission, palliative care specialists completed the Symptom and Problem Checklist of the German Hospice and Palliative Care Evaluation (HOPE-SP-CL). Patients either used the new version of the minimal documentation system for patients in palliative care (MIDOS) or the Integrated Palliative Care Outcome Scale (IPOS) plus the Distress Thermometer (DT). RESULTS: Between 01.01.2016-30.09.2018, 1206 patients were included (HOPE-SP-CL 98%; MIDOS 21%, IPOS 34%, DT 27%) whereof 59% died on the ward. Proxy-assessment showed a mean HOPE-SP-CL Total Score of 24.6 ± 5.9 of 45. Most frequent symptoms/problems of at least moderate intensity were weakness (95%), needs of assistance with activities of daily living (88%), overburdening of family caregivers (83%), and tiredness (75%). Factor analysis identified four symptom clusters (SCs): (1) Deteriorated Physical Condition/Decompensation of Home Care, (2) Emotional Problems, (3) Gastrointestinal Symptoms and (4) Other Symptoms. Self-assessment showed a mean MIDOS Total Score of 11.3 ± 5.3 of 30, a mean IPOS Total Score of 32.0 ± 9.0 of 68, and a mean distress of 6.6 ± 2.5 of 10. Agreement of self- and proxy-assessment was moderate for pain (ƙ = 0.438) and dyspnea (ƙ = 0.503), fair for other physical (ƙ = 0.297 to 0.394) and poor for psychological symptoms (ƙ = 0.101 to 0.202). Multivariate regression analyses for single symptoms and SCs revealed that predictors for dying on the SIPC ward included impaired ECOG performance status, moderate/severe dyspnea, appetite loss, tiredness, disorientation/confusion, and the SC Deteriorated Physical Condition/Decompensation of Home Care. CONCLUSION: Admissions to a SIPC ward are mainly caused by problems impairing mobility and autonomy. Results demonstrate that implementation of self- and reliability of proxy- and self-assessment is challenging, especially concerning non-physical symptoms/problems. We identified, specific symptoms and problems that might provide information needed for treatment discussions regarding the medical prognosis.

Exploring the gender dimension of problems and needs of patients receiving specialist palliative care in a German palliative care unit - the perspectives of patients and healthcare professionals.

BACKGROUND: Gender disparities of specific symptoms and problems have frequently been observed in palliative care patients, but research rarely focused on the range of problems and needs affected by gender. METHODS: We conducted semi-structured interviews with patients and healthcare professionals (HCPs) of a hospital-based palliative care unit to examine gender effects on patients' problems and needs based on systematically gathered qualitative data. Content analysis was used to identify emerging themes with data coded using MAXQDA. RESULTS: Ten patients (5 female, 5 male) and 17 HCPs (12 female, 5 male) were interviewed. Seven categories of gender-specific problems and needs emerged: "physical symptoms, care and body image", "psychological symptoms and emotional response", "interaction with the palliative care team", "use of professional supportive measures", "activation of informal social networks", "decision-making", and "preservation of autonomy and identity". Both patients and HCPs felt that female patients adopt more expressive coping strategies, have stronger need for communication with and support of HCPs, and activate an extended social network for support and decision-making. Further, both groups thought that male patients mainly rely on social support from partners, have higher expectations to be cared for at home, and have higher need for preservation of autonomy. CONCLUSION: Gender relevantly impacts patients' problems and needs during palliative care. Therefore, gender-sensitive palliative care that acknowledges the patient's individual situation and respective ramifications are required.

Specific Characteristics of Patients with Advanced Genitourinary Cancer Receiving Specialized Inpatient Palliative Care.

BACKGROUND: The aim of this study was to compare the characteristics for genitourinary cancer (GUC) patients receiving specialized inpatient palliative care (SIPC) with those of a general cohort. METHODS: We retrospectively evaluated 151 GUC patients receiving SIPC from 2008 to 2014 regarding symptoms, problems, treatment, and outcome. These characteristics were compared with a general cohort of 1,285 patients with various diseases who received SIPC (German Hospice and Palliative care investigation: HOPE). RESULTS: Patients suffering from advanced prostate cancer (n = 59), renal cell cancer (n = 37), urothelial cancer (n = 36), urothelial accompanied by prostate cancer (n = 11), germ cell cancer (n = 7), and penile squamous cell cancer (n = 1) were included in the study. Most frequent symptoms and problems at admission were weakness (93%), the need for assistance with activities of daily living (85%), loss of appetite (81%), and organization of care (80%). Symptoms were more frequent in the GUC than in the general cohort during treatment, in particular with regards to pain (p < 0.001), tension (p < 0.001), nausea (p = 0.001), and vomiting (p < 0.001). GUC patients received significantly more opioids with 89% compared to the general cohort with 72% (p < 0.001). CONCLUSION: Symptom burden of GUC patients, in particular pain, tension, and nausea was higher compared to the general cohort, and analgesic treatment played an important role in achieving control of symptoms.

Quality of life, psychological burden, needs, and satisfaction during specialized inpatient palliative care in family caregivers of advanced cancer patients.

BACKGROUND: This pilot study aimed to investigate quality of life, psychological burden, unmet needs, and care satisfaction in family caregivers of advanced cancer patients (FCs) during specialized inpatient palliative care (SIPC) and to test feasibility and acceptance of the questionnaire survey. METHODS: During a period of 12 weeks, FCs were recruited consecutively within 72 h after the patient's admission. They completed validated scales on several outcomes: quality of life (SF-8), distress (DT), anxiety (GAD-7), depression (PHQ-9), supportive needs (FIN), palliative care outcome (POS), and satisfaction with care (FAMCARE-2). We used non-parametric tests, t-tests and correlation analyses to address our research questions. RESULTS: FCs showed high study commitment: 74 FCs were asked to participate whereof 54 (73%) agreed and 51 (69%) returned the questionnaire. Except for "bodily pain", FCs' quality of life (SF-8) was impaired in all subscales. Most FCs (96%) reported clinically significant own distress (DT), with sadness, sorrows and exhaustion being the most distressing problems (80-83%). Moderate to severe anxiety (GAD-7) and depression (PHQ-9) were prevalent in 43% and 41% of FCs, respectively. FCs scored a mean number of 16.3 of 20 needs (FIN) as very or extremely important (SD 3.3), 20% of needs were unmet in >50% of FCs. The mean POS score assessed by FCs was 16.6 (SD 5.0) and satisfaction (FAMCARE-2) was high (73.4; SD 8.3). CONCLUSIONS: This pilot study demonstrated feasibility of the questionnaire survey and showed relevant psychosocial burden and unmet needs in FCs during SIPC. However, FCs' satisfaction with SIPC seemed to be high. A current multicenter study evaluates these findings longitudinally in a large cohort of FCs.

Integrating patient reported measures as predictive parameters into decisionmaking about palliative chemotherapy: a pilot study.

BACKGROUND: Systemic treatment has proven to improve physical symptoms in patients with advanced cancer. Relationship between quality of life (QoL) or symptom burden (SYB) and treatment efficacy (tumour response and survival) is poorly described. Therefore, we evaluated the predictive value of pretreatment QoL and SYB on treatment outcomes. METHODS: Eligible patients had metastatic gastrointestinal cancers and were about to receive 1st/2nd line palliative chemotherapy. 47 patients were consecutively enrolled. QoL and SYB were assessed by EORTC QLQ-C30 and MSKCC MSAS questionnaires before treatment and after first response evaluation after 8-12 weeks. Logistic regression analysis of QoL and SYB for prediction of objective treatment efficacy was performed. Patients were categorized according to response rate (RR) based on RECIST1.1 and progression free survival (PFS). PFS was categorized by a ratio (individual PFS/expected PFS) in above median (ratio ≥ 1) or below median PFS (ratio < 1). QoL and SYB were analysed for RR groups (partial response, stable or progressive disease) and PFS ratio (PFSR). RESULTS: Objective response to chemotherapy and increase in PFS were associated with better pretreatment QoL and less SYB. Patients with future objective treatment efficacy (PFSR ≥ 1) evidenced clinically relevant better role/emotional/cognitive/social functioning and less fatigue and appetite loss at baseline in comparison to PFSR < 1 (>10 points difference). Lowest scores in all functioning scales at treatment start were seen in patients with future PFSR < 1. Global health status (EORTC), PSYCH subscale and global distress index (MSAS) predicted PFSR, even if adjusted for gender, age, cancer type, ECOG and line of treatment (p < 0.05). Interestingly, improved QoL and SYB (subjective benefit) were noted even in patients with worse pretreatment status and no objective tumour response. CONCLUSION: Future non-responders seem to show distinct QoL patterns before chemotherapy. This may facilitate early detection of patients deriving less or even no benefit from treatment regarding prolongation of survival. Even in patients with primarily progressive disease QoL and SYB may improve during treatment. Integration of QoL and SYB assessment into decision-making about palliative chemotherapy seem to be an important approach to improve patient outcome and should be further evaluated.

Symptom burden in palliative care patients: perspectives of patients, their family caregivers, and their attending physicians.

RATIONALE: The purpose of this study was to prospectively evaluate the perspectives of palliative care patients, their family caregivers, and their attending palliative care specialists on frequency, intensity, distress, and treatment requirement of the patient's physical and psychological symptoms. PATIENTS AND METHODS: Forty advanced cancer patients and their family caregivers were recruited through a palliative care inpatient ward within 24 h after admission. Patients, caregivers, and physicians completed a modified version of the Memorial Symptom Assessment Scale (including perceived treatment requirement). RESULTS: Thirty-nine patients (98 %) suffered from at least one symptom frequently or almost constantly (median number 5; range, 0-9). Most frequent symptoms were lack of energy (95 %), tiredness (88 %), and pain (80 %), which were scored correspondingly by patients, caregivers, and physicians to be the most intensive, distressing, and treatment requiring. Treatment requirement was determined by symptom intensity or distress in patients and physicians, but by distress in caregivers. Significant differences in symptom burden between patients, caregivers, and physicians were found with regard to pain (p = .007), tiredness (p = .037), lack of energy (p < .05), anxiety (p < .05), and sadness (p < .05). Physicians underestimated 60 % of symptom dimensions, while the caregivers overestimated 77 %; however, overall median scoring differences were limited with -.10 (range, -.55 to +.25) between patients and physicians and +.33 (range, -.78 to +.61) between patients and family caregivers. CONCLUSIONS: While physicians tended to underestimate, family caregivers tended to overestimate the patient's symptoms. Therefore, adequate symptom treatment can only be successful in a close dialog between patients, their caregivers, and a multidisciplinary team.

Prospective comparison of [18F]fluorodeoxyglucose positron emission tomography with conventional assessment by computed tomography scans and serum tumor markers for the evaluation of residual masses in patients with nonseminomatous germ cell carcinoma.

BACKGROUND: To assess the ability of [(18)F]fluorodeoxyglucose (F-18 FDG) positron emission tomography (PET) to predict the viability of residual masses after chemotherapy in patients with metastatic nonseminomatous germ cell tumors (GCT), PET results were compared in a blinded analysis with computed tomography (CT) scans and serum tumor marker changes (TUM) as established methods of assessment. METHODS: Independent reviewers who were blinded to each other's results evaluated the PET results and corresponding CT scan and TUM results in 85 residual lesions from 45 patients. All patients were treated within prospective clinical trials and received primary/salvage, high-dose chemotherapy with autologous blood stem cell support for primary poor prognosis disease or recurrent disease. PET results were assessed both visually and by quantifying glucose uptake (standardized uptake values). Results were validated either by histologic examination of a resected mass and/or biopsy (n = 28 lesions) or by a 6-month clinical follow-up after evaluation (n = 57 lesions). RESULTS: F-18 FDG PET showed increased tracer uptake in 32 of 85 residual lesions, with 29 true positive (TP) lesions and three false positive (FP) lesions. Fifty-three lesions were classified by PET as negative (no viable GCT), 33 lesions were classified by PET as true negative (TN), and 20 lesions were classified by PET as false negative (FN). In the blinded reading of the corresponding CT scan and TUM results, 38 residual lesions were assessed correctly as containing viable carcinoma and/or teratoma. Forty-six lesions were classified as non-suspicious by CT scan/TUM (33 TN lesions and 14 falsely classified lesions). PET correctly predicted the presence of viable carcinoma in 5 of these 14 and the absence of viable carcinoma in 3 of these 14 lesions. Resulting sensitivities and specificities for the prediction of residual mass viability were as follows: PET, 59% sensitivity and 92% specificity; radiologic monitoring, 55% sensitivity and 86% specificity; and TUM, 42% sensitivity and 100% specificity. The positive and negative predictive values for PET were 91% and 62%, respectively. The diagnostic efficacy of PET did not improve when patients with teratomatous elements in the primary tumor were excluded from the analysis. In patients with multiple residual masses, a uniformly increased residual F-18 FDG uptake in all lesions was a strong predictor for the presence of viable carcinoma. CONCLUSIONS: F-18 FDG PET imaging performed in conjunction with conventional staging methods offers additional information for the prediction of residual mass histology in patients with nonseminomatous GCT. A positive PET is highly predictive for the presence of viable carcinoma. Other useful indications for a PET examination include patients with multiple residual masses and patients with marker negative disease.