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Claudia SEW Schuurhuizen,1,2 Henk MW Verheul,1 Annemarie MJ Braamse,3 Laurien M Buffart,1–4 Haiko J Bloemendal,5 Joost Dekker,2,6,* Inge RHM Konings1,* 1Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands; 2Department of Psychiatry, Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam, The Netherlands; 3Department of Medical Psychology, Academic Medical Center Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands; 4Department of Epidemiology and Biostatistics, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands; 5Department of Medical Oncology, Meander Medical Center, Amersfoort, The Netherlands; 6Department of Rehabilitation Medicine, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands *These authors contributed equally to this work Background: Studies evaluating new systemic agents tend to report severe toxicities only, while the cumulative effect of multiple lower grade adverse events (AEs) may have an additional negative impact on patient quality of life (QOL). In the current observational cohort study, we evaluated whether, in patients with metastatic colorectal cancer receiving first-line chemotherapy, cumulative toxicity comprising all grades of AEs is more predictive for QOL than cumulative toxicity due to only high-grade AEs.Methods: One hundred and five patients starting treatment completed the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) questionnaire at baseline and 10 weeks. AEs, clinical outcomes, and demographics were retrieved from patient records. Cumulative toxicity scores were calculated in three ways: total number of high-grade AEs, total number of all-grade AEs, and total number of AEs multiplied by their grade (the severity score). Relations between cumulative toxicity scores and QOL were studied using multivariable linear regression analyses.Results: The mean age of patients was 65 years, 68% were male, and 84% received oxaliplatin-based chemotherapy. A higher total number of AEs of all grades (B=−2.4, 95% CI=–3.9; –0.9) and the severity score (B=–1.4, 95% CI=–2.3; –0.5) were predictive for clinically relevant changes in physical QOL, whereas the total high-grade AEs was not. None of the cumulative toxicity scores were predictive for global QOL.Conclusion: Cumulative toxicity scores comprising all grades of AEs provide a better measure of treatment burden than a toxicity score comprising high-grade AEs only. Physical QOL seems to be more affected by AEs than global QOL. Our results emphasize that future clinical trials should present cumulative toxicity scores comprising all AE grades as well as physical QOL instead of global QOL. Keywords: cumulative toxicity, treatment-related toxicity, adverse events, quality of life, metastatic colorectal cancer

Purpose: This study evaluated the effects of coping skills training (CST) on symptoms of depression and anxiety in cancer patients, and investigated moderators of the effects., Methods: Overall effects and intervention-related moderators were studied in meta-analyses of pooled aggregate data from 38 randomized controlled trials (RCTs). Patient-related moderators were examined using linear mixed-effect models with interaction tests on pooled individual patient data (n = 1953) from 15 of the RCTs., Results: CST had a statistically significant but small effect on depression (g = -0.31,95% confidence interval (CI) = -0.40;-0.22) and anxiety (g = -0.32,95%CI = -0.41;-0.24) symptoms. Effects on depression symptoms were significantly larger for interventions delivered face-to-face (p = .003), led by a psychologist (p = .02) and targeted to patients with psychological distress (p = .002). Significantly larger reductions in anxiety symptoms were found in younger patients (p interaction  < 0.025), with the largest reductions in patients <50 years (β = -0.31,95%CI = -0.44;-0.18) and no significant effects in patients ≥70 years. Effects of CST on depression (β = -0.16,95%CI = -0.25;-0.07) and anxiety (β = -0.24,95%CI = -0.33;-0.14) symptoms were significant in patients who received chemotherapy but not in patients who did not (p interaction  < 0.05)., Conclusions: CST significantly reduced symptoms of depression and anxiety in cancer patients, and particularly when delivered face-to-face, provided by a psychologist, targeted to patients with psychological distress, and given to patients who were younger and received chemotherapy., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: Up to 37% of colorectal cancer (CRC) survivors report depressive and anxiety symptoms. The identification of risk factors for depressive or anxiety symptoms might help focus supportive care resources on those patients most in need. The present study aims to explore which factors are associated with heightened anxiety or depression symptom severity., Methods: In this cross-sectional study, individuals diagnosed with CRC 3.5 to 6 years ago completed questionnaires on sociodemographic information, medical comorbidities, anxiety symptoms (Beck Anxiety Inventory), and depressive symptoms (Inventory of Depressive Symptomatology). The general linear model analysis of covariance was used to identify factors associated with heightened anxiety or depressive symptom severity., Results: The sample included 91 CRC survivors, 40.7% women, mean age 69.1 years. A minority of CRC survivors had moderate (3.4%) or severe (2.3%) anxiety symptoms, and moderate (7.7%) or severe (0%) depressive symptoms. Shorter time since diagnosis and higher number of comorbid diseases were associated with higher anxiety symptom severity. Female sex and higher number of comorbid diseases were associated with higher depressive symptom severity., Conclusion: From this explorative study, it follows that survivors with multiple comorbid diseases, shorter time since diagnosis, and female survivors might be at risk for higher anxiety and/or depressive symptom severity. Survivors with these characteristics might need extra monitoring.

Hematopoietic cell transplantation (HCT) is associated with impaired physical and psychological functioning for some long-term survivors. A risk prediction model would help clinicians estimate their patients' physical and psychological functioning after HCT and determine when to refer to added supportive care when appropriate. The purpose of the present study was to develop risk prediction models for physical and psychological functioning in HCT survivors. This was a secondary analysis of data from a randomized controlled trial (NCT00799461) that included 3- to 10-year HCT survivors. Risk predictions for physical and psychological functioning were developed by using backward logistic regression. The models were internally validated using bootstrapping techniques. Regression coefficients were converted into easy-to-use risk scores. Finally, the sensitivity, specificity, and positive and negative predictive values of the total risk score were calculated. The analyses included 489 survivors, with a mean age of 45.6 (SD, 12.4) years; 47% were female and with a mean of 6.1 years (SD, 2.0) after transplantation. Younger age, higher body mass index (BMI), no or part-time work, more comorbid diseases, autologous transplantation, and chronic graft-versus-host disease predicted impaired physical functioning. Female gender, younger age, higher BMI, not living with a partner, autologous transplantation, and chronic graft-versus-host disease predicted impaired psychological functioning. Although both models had predictive value for long-term functioning, diagnostic accuracy was moderate. For the physical functioning receiver operating characteristic, area under the curve (AUC) after internal validation was .74 with sensitivity 51.9 and specificity 82.8 at the optimal cut-off. For psychological functioning, AUC after internal validation was .69 with sensitivity 83.3 and specificity 42.9 at the optimal cut-off. We conclude that it is possible to predict long-term physical and psychological functioning with readily accessible, mostly pretransplantation predictors. The accuracy of the risk prediction models can be improved for use in clinical practice, potentially by adding pretransplantation patient-reported functioning and comorbidities., (Copyright © 2016 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.)

Background/introduction: Psychological distress occurs frequently in patients with cancer. Psychological distress includes mild and severe forms of both anxious and depressive mood states. Literature indicates that effective management of psychological distress seems to require targeted selection of patients (T), followed by enhanced care (E), and the application of evidence based interventions. Besides, it is hypothesized that delivering care according to the stepped care (S) approach results in an affordable program. The aim of the current study is to evaluate the (cost)-effectiveness of the TES program compared to usual care in reducing psychological distress in patients with metastatic colorectal cancer (mCRC)., Methods: This study is designed as a cluster randomized trial with 2 treatment arms: TES program for screening and treatment of psychological distress versus usual care. Sixteen hospitals participate in this study, recruiting patients with mCRC. Outcomes are evaluated at the beginning of chemotherapy and after 3, 10, 24, and 48 weeks. Primary outcome is the difference in treatment effect over time in psychological distress, assessed with the Hospital Anxiety and Depression Scale. Secondary outcomes include quality of life, patient evaluation of care, recognition and management of psychological distress, and societal costs., Discussion: We created optimal conditions for an effective screening and treatment program for psychological distress in patients with mCRC. This involves targeted selection of patients, followed by enhanced and stepped care. Our approach will be thoroughly evaluated in this study. We expect that our results will contribute to the continuing debate on the (cost-) effectiveness of screening for and treatment of psychological distress in patients with cancer., Trial Registration: This trial is registered in the Netherlands Trial Register NTR4034.

Hematological malignancies and treatment with hematopoietic SCT are known to affect patients' quality of life. The problem profile and care needs of this patient group need clarification, however. This study aimed to assess distress, problems and care needs after allo- or auto-SCT, and to identify risk factors for distress, problems or care needs. In this cross-sectional study, patients treated with allo-SCT or auto-SCT for hematological malignancies completed the Distress Thermometer and Problem List. Three patient groups were created: 0-1, 1-2.5 and 2.5-5.5 years after transplantation. After allo-SCT, distress and the number of problems tended to be lower with longer follow-up. After auto-SCT, distress was highest at 1-2.5 year(s). Patients mainly reported physical problems, followed by cognitive-emotional and practical problems. A minority reported care needs. Risk factors for distress as well as problems after allo-SCT included younger age, shorter time after transplantation and GVHD. A risk factor for distress as well as problems after auto-SCT was the presence of comorbid diseases. Up to 5 years after auto-SCT or allo-SCT, patients continue to experience distress and problems. Judged by prevalence, physical problems are first priority in supportive care, followed by cognitive-emotional and practical problems.

Identifying factors that predict health-related quality of life (QOL) following hematopoietic SCT, is important in estimating patients' abilities to adjust to the consequences of their disease and treatment. As the studies that have been published on this subject are scattered, the present study aimed to systematically review prognostic factors for health-related QOL after auto- and allo-SCT in hematological malignancies. A systematic, computerized search in Medline, EMBASE, PsycINFO and the Cochrane Library was conducted from 2002 to June 2010. The methodological quality of the studies was assessed using an adaptation of Hayden's criteria list. Qualitative data synthesis was performed to determine the strength of the scientific evidence. In all, 35 studies fulfilled the selection criteria. Strong-moderate evidence was found for GVHD, conditioning regimen, being female, younger age, receiving less social support and pre-transplant psychological distress as predictors of various aspects of health-related QOL following hematopoietic SCT. The results of this review may help transplant teams in selecting patients at risk for experiencing a diminished health-related QOL following hematopoietic SCT. Follow-up treatment can be provided in order to promote QOL.

Background: Psychological distress (i.e. depression and anxiety) is a strong predictor of functional status and other aspects of quality of life in autologous stem cell transplantation following high-dose chemotherapy. Treatment of psychological distress is hypothesized to result in improvement of functional status and other aspects of quality of life. The aim is to evaluate the outcome of stepped care for psychological distress on functional status and other aspects of quality of life in patients with hematological malignancy treated with autologous stem cell transplantation., Methods/design: The study is designed as a randomized clinical trial with 2 treatment arms: a stepped care intervention program versus care as usual. Patients are randomized immediately pre transplant. Stepped care and care as usual are initiated after a 6 weeks buffer period. Outcome is evaluated at 13, 30, and 42 weeks post transplant.In the experimental group, the first step includes an Internet-based self-help program. If psychological distress persists after the self-help intervention, the second step of the program is executed, i.e. a diagnostic evaluation and a standardized interview, yielding a problem analysis. Based on this information, a contract is made with the patient and treatment is provided consisting of individual face-to-face counseling, medication, or referral to other services. Care as usual comprises an interview with the patient, on ad hoc basis; emotional support and advice, on ad hoc basis; if urgent problems emerge, the patient is referred to other services.Primary outcome variables are psychological distress and functional status. Data are analyzed according to the intention to treat-principle., Discussion: This study has several innovative characteristics. First, the outcome of the intervention for psychological distress in patients with hematological malignancy treated with autologous stem cell transplantation is evaluated in a randomized controlled study. Second, the impact of the intervention on functional status is evaluated: it is hypothesized that reduction of psychological distress results in improved functional status. Furthermore, the intervention concerns an Internet-based treatment in the first step. Finally, the intervention is characterized by an emphasis on self-management, efficiency, and a multi-disciplinary approach with nurses taking up a central role., Trial Registration: NTR1770.