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Objective: The aims of this study were to investigate the characteristics of users of a specific child-centred counselling service (COSIP) and to compare those to parents using an individual psycho-oncological treatment (PO).Methods: We conducted a retrospective analysis on data of users of COSIP and users of PO. Database was the routine assessment (demographic and disease-related characteristics, GAD-7, PHQ-9, EORTC QLQ-C30, and current concerns) of an outpatient psycho-oncological clinic with additional child-centred counselling. A total of 151 patients and 49 partners with children ≤21 years were included. We conducted descriptive analyses and group comparisons.Results: Fifty-nine patients and partners used COSIP only or additionally to individual psycho-oncological service. PO users were more depressed and were more anxious than COSIP users. Patients using PO reported worse emotional functioning than patients using COSIP. Partners using PO reported worse global quality of life and more symptoms of fatigue than partners using COSIP. With regard to current concerns, patients using COSIP reported child-related issues more frequently than PO users. PO users reported symptoms of anxiety, depressive symptoms, or exhaustion more frequently than COSIP users.Conclusions: The findings demonstrate that patients and partners self-referring to PO or COSIP are highly burdened. COSIP users experience different psychosocial burden than PO users. As poor mental state of parents is a risk factor for the development of mental problems in children, parents using only PO may benefit from additional child-centred support. Accordingly, the need for COSIP should be assessed continuously during PO of patients with children ≤21 years. [ABSTRACT FROM AUTHOR]

Background: In this prospective multicenter study, we investigated cancer-and-treatment-specific distress (CTXD) and its impact on symptoms of posttraumatic stress disorder (PTSD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).Methods: Patients were consulted before (T0, N = 239), 3 (T1, N = 150), and 12 months (T2, N = 102) after HSCT. Medical (eg, diagnosis and pretreatment) and demographic information, CTXD and PTSD (PCL-C) were assessed.Results: Random intercept models revealed that the sum score of CTXD was highest pre-HSCT (T0), decreased by T1 (γ = -.18, 95% CI [-.26/-.09]), and by T2 (γ = -.10, 95% CI [-.20/-.00]). Uncertainty, family strain, and health burden were rated most distressing during HSCT. Uncertainty and family strain decreased from T0 to T1 (γ = -.30, 95% CI [-.42/-.17]; γ = -.10, 95% CI [-.20/-.00]) and health burden from T1 to T2 (γ = -.21, 95% CI [-.36/.05]). Women were more likely to report uncertainty (γ = .38, 95% CI [.19/.58]), family strain (γ = .38, 95% CI [.19/.58]), and concerns regarding appearance and sexuality (γ = .31, 95% CI [.14/.47]) than men. Uncertainty (γ = .18, 95% CI [.12/.24]), appearance and sexuality (γ = .09, 95% CI [.01/.16]), and health burden (γ = .21, 95% CI [.14/.27]) emerged as predictors of PTSD symptomatology across the 3 assessment points.Conclusions: Our data provide first evidence regarding the course of 6 dimensions of CTXD during HSCT and their impact on PTSD symptomatology. Specifically, results emphasize the major burden of uncertainty pre-HSCT and the impact of uncertainty and concerns regarding appearance and sexuality on PTSD symptomatology. [ABSTRACT FROM AUTHOR]

Background: Personal last wishes of people facing a life-limiting illness may change closer to death and may vary across different forms of specialist palliative care (SPC). Aims: To explore the presence and common themes of last wishes over time and according to the SPC settings (inpatient vs. home-based SPC), and to identify factors associated to having a last wish. Methods: Patients enrolled in a longitudinal study completed questionnaires at the onset (baseline, t0) and within the first 6 weeks (follow-up, t1) of SPC including an open-ended question on their personal last wishes. Last wishes were content analyzed, and all wishes were coded for presence or absence of each of the identified themes. Changes of last wishes (t0-t1) were analyzed by a McNemar test. The chi-square-test was used to compare the two SPC settings. Predictors for the presence of a last wish were identified by logistic regression analysis. Results: Three hundred sixty-one patients (mean age, 69.5 years; 49% female) answered at t0, and 130 at t1. In cross-sectional analyses, the presence of last wishes was higher at t0 (67%) than at t1 (59%). Comparisons revealed a higher presence of last wishes among inpatients than those in home-based SPC at t0 (78% vs. 62%; p =.002), but not at t1. Inpatient SPC (OR = 1.987, p =.011) and greater physical symptom burden over the past week (OR = 1.168, p <.001) predicted presence of a last wish at t0. Common themes of last wishes were Travel, Activities, Regaining health, Quality of life, Being with family and friends, Dying comfortably, Turn back time, and Taking care of final matters. The most frequent theme was Travel, at both t0 (31%) and t1 (39%). Themes did not differ between SPC settings, neither at t0 nor at t1. Longitudinal analyses (t0-t1) showed no significant intra-personal changes in the presence or any themes of last wishes over time. Conclusions: In this late phase of their illness, many patients voiced last wishes. Our study suggests working with such wishes as a framework for person-centered care. Comparisons of SPC settings indicate that individualized approaches to patients' last wishes, rather than setting-specific approaches, may be important. [ABSTRACT FROM AUTHOR]

Background: We investigated the need for additional professional support and associated factors in patients (pts) at initiation and in the course of in- and outpatient specialist palliative care (I-SPC/O-SPC). Methods: Pts entering an urban SPC network consecutively completed questionnaires on psychosocial/spiritual problems and support needs within 72 h (T0) as well as within the first 6 weeks (T1) of SPC. Hierarchical linear regression analysis was used to investigate the impact of sociodemographic / disease-related variables, psychological / physical burden, social support, and SPC setting on the extent of support needs. Results: Four hundred twenty-five pts (70 years, 48% female, 91% cancer, 67% O-SPC) answered at T0, and 167 at T1. At T0, main problems related to transportation, usual activities, and dependency (83–89%). At T1, most prevalent problems also related to transportation and usual activities and additionally to light housework (82–86%). At T0, support needs were highest for transportation, light housework, and usual activities (35–41%). Cross-sectional comparisons of SPC settings revealed higher problem scores in O-SPC compared to I-SPC at T0 (p =.039), but not at T1. Support need scores were higher in O-SPC at T0 (p <.001), but lower at T1 (p =.039). Longitudinal analyses showed a decrease of support need scores over time, independent from the SPC setting. At T0, higher distress (p =.047), anxiety/depression (p <.001), physical symptom burden (p <.001) and I-SPC (p <.001) were associated with higher support need scores (at T1: only higher distress, p =.037). Conclusion: Need for additional professional psychosocial/spiritual support was identified in up to 40% of pts. with higher need at the beginning of O-SPC than of I-SPC. During SPC, this need decreased in both settings, but got lower in O-SPC than in I-SPC over time. Support need scores were not only associated with psychological, but also physical burden. [ABSTRACT FROM AUTHOR]

Key points: A monthly videoconference was maintained over 1 year, allowing senior psychooncologists from German Comprehensive Cancer Centers to discuss the implications of the Covid‐19 pandemic for psychooncological care.In the early phase of the pandemic, a widespread disruption of psychooncological services was noted.Rapidly developed adaptations of regular services worked well and sometimes brought about unexpected, creative solutions.In March 2021, the high numbers of infections, the occurrence of new variants of the coronavirus, and the slow progress in vaccination raise fears about new disruptions and restrictions in service provision.In coping with the pandemic, many therapists have felt like many cancer patients do feel in the process of coping with cancer, and this might help to better understand our patients. [ABSTRACT FROM AUTHOR]

Objective: We aimed to determine whether the Managing Cancer and Living Meaningfully (CALM) therapy is superior to a non‐manualized supportive psycho‐oncological counselling intervention (SPI). Methods: Adult patients with advanced cancer and ≥9 points on the PHQ‐9 and/or ≥5 points on the DT were randomized to CALM or SPI. We hypothesized that CALM patients would report significantly less depression (primary outcome) on the BDI‐II and the PHQ‐9 6 months after baseline compared to SPI patients. Results: From 329 eligible patients, 206 participated (61.2% female; age: M = 57.9 [SD = 11.7]; 84.5% UICC IV stage). Of them, 99 were assigned to CALM and 107 to SPI. Intention‐to‐treat analyses revealed significantly less depressive symptoms at 6 months than at baseline (P <.001 for BDI‐II and PHQ‐9), but participants in the CALM and SPI group did not differ in depression severity (BDI‐II: P =.62, PHQ‐9: P =.998). Group differences on secondary outcomes were statistically not significant either. Conclusions: CALM therapy was associated with reduction in depressive symptoms over time but this improvement was not statistically significant different than that obtained within SPI group. [ABSTRACT FROM AUTHOR]

Purpose: The diagnosis of a terminal disease bears existential challenges, which activate the attachment system. Attachment insecurity, as well as existential resources, such as spiritual well-being, influences patients' extent of psychological distress. Knowledge about the interrelation of these constructs is limited. Based on current research, we assume spiritual well-being to mediate the association of attachment insecurity and psychological distress.Methods: We obtained data from the baseline measurement of a randomized controlled trial in advanced cancer patients. Patients were sampled from the University Medical Centers of Hamburg and Leipzig, Germany. Main outcome measures included the Patient Health Questionnaire (PHQ-9), the Death and Dying Distress Scale (DADDS), the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp), and the Experience in Close Relationships Scale (ECR-M16) for assessing attachment insecurity. We tested the mediation hypothesis with two regression analyses using bootstrapping procedure.Results: A total of 190 patients were included. Spiritual well-being mediated the association of attachment insecurity and depression (R2 = 11%), as well as death anxiety (R2 = 15%), in fearful-avoidant attached patients. Neither dismissingly nor preoccupied attached patients differ in terms of spiritual well-being and psychological distress in comparison with secure attached patients.Conclusion: Spiritual well-being plays a relevant role in advanced cancer patient's mental health through mediating the association of attachment and psychological distress. Developing a better understanding of the interdependency of the constructs of spiritual well-being and attachment can help to develop individually tailored advanced cancer care programs and psychotherapeutic interventions.Trial Registration: NCT02051660. [ABSTRACT FROM AUTHOR]

Background: Advanced diseases pose a great burden on patients and go hand in hand with existential concerns. Demoralization is considered as a syndrome of existential distress with a perceived inability to cope with loss of meaning in life and feelings of helplessness and hopelessness. Professional health care providers play an important role in providing support for patients and unfavorable conversational styles in their relationship can increase patient's distress. In this study, we examine the association between the patient's perceived relationship to health care providers and demoralization.Methods: We used baseline data of a randomized control trial intervention study for advanced cancer patients (UICC-Stage ≥ III; PHQ ≥ 9 and/or Distress-Thermometer ≥5). We used a subscale of the QUAL-EC-P for assessing doctor-patient relationship, Beck Depression Inventory-II for depressive symptoms, a modified version of the MSAS as physiological symptom checklist, and the Demoralization Scale to assess demoralization. A hierarchical regression analysis was calculated.Results: In our sample of 187 patients with stage III or IV cancer (62% women), demoralization was present in 53.4% (16% moderate demoralization; 37.4% high demoralization) of the patients. Relationship to health care provider was an independent predictor (β = -.33, t(186) = -6.70, P < .001) of demoralization.Conclusions: Our findings underline the importance of the physician-patient relationship in the context of coping with existential challenges in advanced cancer patients. Trainings on how to communicate and build a sustainable relationship with patients and their specific needs may increase the buffering effect of social support by the physicians on patient's existential distress. [ABSTRACT FROM AUTHOR]

Context: Due to toxicity and invasiveness, allogeneic hematopoietic stem cell transplantation causes severe and longstanding symptom burden. Longitudinal studies on symptoms and symptom clusters (SC) would be helpful to optimize symptom control but are rare to date.Objectives: The objective of this study was to investigate stability of symptoms, extract time stable SC, and determine their priority in symptom management.Methods: In this multicenter study, patients diagnosed with hematologic cancer were assessed before conditioning (T0) and three months (T1), one year (T2), and five years (T3) after transplantation. Symptoms were assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30). Symptoms were stable when rated as present at three consecutive time points. Applying factor analysis, stable SC were composed of symptoms loading on the same factor across all time points. Priority in symptom management was derived from a combination of severity and predictive power for quality of life (QoL).Results: Two hundred thirty-nine patients participated at T0, 150 (63%) at T1, 102 (43%) at T2, and 45 (19%) at T3. We identified three stable SC, composed of rest-tired-weak-dyspnea-loss of appetite (exhausted), tense-worried-irritable-depressed (affective), and nausea-vomiting (gastrointestinal). Fatigue was most persistent and also most severe and predictive for QoL, both as symptom and in cluster (exhausted).Conclusion: Given its high stability, severity, and impact on QoL, fatigue should have priority in symptom management. The treatment of this symptom could be enhanced by also incorporating interventions addressing dyspnea and loss of appetite. [ABSTRACT FROM AUTHOR]

Context: Attachment insecurity refers to difficulty in trusting and relying on others in times of need. Its underlying factors attachment anxiety and attachment avoidance have been empirically associated with impaired coping in advanced cancer and, therefore, should be considered in individually tailored medical and psychosocial treatment.Objectives: The objective of this study was to evaluate the psychometric properties of the German translation of the Brief Experiences in Close Relationships Scale (ECR-M16-G).Methods: We recruited 182 advanced cancer patients from outpatient psycho-oncology clinics of the University Medical Center Hamburg-Eppendorf and the University Medical Center Leipzig, local and external cancer care facilities. We performed confirmatory factor analysis to replicate the higher order factor structure reported in previous research. We conducted item and reliability analysis, also correlation analysis, to examine concurrent validity.Results: One hundred fifty-eight patients completed the ECR-M16-G (women 61%, mean age 57.9, SD = 11.1). We replicated the factor structure with the subscales Attachment Anxiety and Attachment Avoidance as second-order factors and Worrying about relationships, Frustration about unavailability, Discomfort with close others, and Turning away from others as first-order factors. An adjusted model that interchanged factor loadings of items 4 and 10 showed good fit (Comparative Fit Index = 0.94, Non-Normed Fit Index = 0.93, root mean square error of approximation = 0.05). Subscales showed acceptable to good internal consistency (anxiety α = .81 and avoidance α = .78). Attachment insecurity (mean = 3.1, SD = 1.0) was positively associated with depression, anxiety, demoralization (P < 0.001), and symptom burden (P = 0.02) and negatively associated with spiritual well-being (P < 0.001).Conclusion: The ECR-M16-G is a valid and reliable measure of attachment insecurity in patients with advanced cancer and can be recommended as a tool for clinical care and further research. [ABSTRACT FROM AUTHOR]

Context: Distress and anxiety about issues related to death and dying is commonly experienced in patients with advanced disease and a limited life expectancy.Objectives: To evaluate the psychometric properties of the German version of the Death and Dying Distress Scale (DADDS-G) in advanced cancer patients.Methods: We recruited advanced patients with mixed tumor entities (Union for International Cancer Control [UICC] Stage III/IV) treated in two German University Medical Centers during their outpatient treatment. After testing a preliminary version of the state-of-the-art translated original Death and Dying Distress Scale, we analyzed the psychometric properties of the shortened nine-item adapted DADDS-G using validated instruments measuring distress, anxiety, depression, fear of progression, and quality of life.Results: We obtained complete questionnaires from 77 of 93 patients with advanced cancer (response rate: 83%). Participants were mostly married or cohabiting (75%), well-educated, and both sexes were almost equally represented (52% men; mean age 58 years, SD = 12). The total mean DADDS-G score was 13.3 (SD = 8.5). Patients reported to be most distressed by the feeling of being a burden to others. The exploratory factor analysis led to one factor that accounted for more than 59% of the variance. The DADDS-G's internal consistency was excellent with Cronbach alpha = 0.91. The confirmatory factor analysis demonstrated a very good model fit. Death-related anxiety was significantly associated with distress, depression, anxiety, fear of progression, and lower quality of life (P < 0.001).Conclusion: Results provide further evidence that the DADDS-G is a valid and reliable instrument of high clinical relevance for use in patients with advanced cancer. [ABSTRACT FROM AUTHOR]

Background: Although psycho-oncological interventions have been shown to significantly reduce symptoms of anxiety and depression and enhance quality of life, a substantial number of patients with advanced cancer do not receive psycho-oncological interventions tailored to their individual situation. Given the lack of reliable data on the efficacy of psycho-oncological interventions in palliative care settings, we aim to examine the efficacy of a brief, manualized individual psychotherapy for patients with advanced cancer: Managing Cancer and Living Meaningfully (CALM). CALM aims to reduce depression and death anxiety, to strengthen communication with health care providers, and to enhance hope and meaning in life. We adapted the intervention for German cancer care settings. Methods/Design: We use a single-blinded randomized-controlled trial design with two treatment conditions: intervention group (IG, CALM) and control group (CG). Patients in the CG receive a usual non-manualized supportive psycho-oncological intervention (SPI). Patients are randomized between the IG and CG and assessed at baseline (t0), after three (t1) and after 6 months (t2). We include patients with a malignant solid tumor who have tumor stages of III or IV (UICC classification). Patients who are included in the study are at least 18 years old, speak German fluently, score greater than or equal to nine on the PHQ-9 or/and greater than or equal to five on the Distress Thermometer. It is further necessary that there is no evidence of severe cognitive impairments. We measure depression, anxiety, distress, quality of life, demoralization, symptom distress, fatigue as well as spiritual well-being, posttraumatic growth and close relationship experiences using validated questionnaires. We hypothesize that patients in the IG will show a significantly lower level of depression 6 months after baseline compared to patients in the CG. We further hypothesize a significant reduction in anxiety and fatigue as well as significant improvements in psychological and spiritual well-being, meaning and post-traumatic growth in the IG compared to CG 6 months after baseline. Discussion: Our study will contribute important statistical evidence on whether CALM can reduce depression and existential distress in a German sample of advanced and highly distressed cancer patients. [ABSTRACT FROM AUTHOR]

Background: Although psycho-oncological interventions have been shown to significantly reduce symptoms of anxiety and depression and enhance quality of life, a substantial number of patients with advanced cancer do not receive psycho-oncological interventions tailored to their individual situation. Given the lack of reliable data on the efficacy of psycho-oncological interventions in palliative care settings, we aim to examine the efficacy of a brief, manualized individual psychotherapy for patients with advanced cancer: Managing Cancer and Living Meaningfully (CALM). CALM aims to reduce depression and death anxiety, to strengthen communication with health care providers, and to enhance hope and meaning in life. We adapted the intervention for German cancer care settings. Methods/Design: We use a single-blinded randomized-controlled trial design with two treatment conditions: intervention group (IG, CALM) and control group (CG). Patients in the CG receive a usual non-manualized supportive psycho-oncological intervention (SPI). Patients are randomized between the IG and CG and assessed at baseline (t0), after three (t1) and after 6 months (t2). We include patients with a malignant solid tumor who have tumor stages of III or IV (UICC classification). Patients who are included in the study are at least 18 years old, speak German fluently, score greater than or equal to nine on the PHQ-9 or/and greater than or equal to five on the Distress Thermometer. It is further necessary that there is no evidence of severe cognitive impairments. We measure depression, anxiety, distress, quality of life, demoralization, symptom distress, fatigue as well as spiritual well-being, posttraumatic growth and close relationship experiences using validated questionnaires. We hypothesize that patients in the IG will show a significantly lower level of depression 6 months after baseline compared to patients in the CG. We further hypothesize a significant reduction in anxiety and fatigue as well as significant improvements in psychological and spiritual well-being, meaning and post-traumatic growth in the IG compared to CG 6 months after baseline. Discussion: Our study will contribute important statistical evidence on whether CALM can reduce depression and existential distress in a German sample of advanced and highly distressed cancer patients. [ABSTRACT FROM AUTHOR]

Background Owing to its neurotoxicity, allogeneic hematopoietic stem cell transplantation (HSCT) carries risks for cognitive impairment. In this multicenter study, we prospectively evaluated cognitive functioning and its medical and demographic correlates in patients undergoing allogeneic HSCT. Methods A total of 102 patients were consecutively assessed prior to (T0), 100 ± 20 days (T1) after, and 12 ± 1 months (T2) after HSCT (61% men, 41% acute myeloid leukemia). A comprehensive neuropsychological test battery was applied to evaluate attention, memory, executive function, and fine motor function, summing up into 14 test scores. Results Before and after HSCT, patients performed below test norms in up to 50% of the test scores. Patients were mostly impaired on word fluency (24%, T0), fine motor function, and verbal delayed recall (19% each, T2). Impairment on ≥1/5 cognitive domains occurred in 47% (T0) and 41% (T2) of the patients. Performance (mean z-scores) partially improved over time (i.e., visual span forward, verbal learning, and word fluency). However, from baseline to T2, 16% of the patients showed reliable decline on ≥3/14 test scores (reliable change index method). For the majority of neuropsychological subtests, no associations with conditioning intensity, total body irradiation, graft-versus-host disease, cyclosporine treatment, and length of hospital stay were found. Age and premorbid intelligence level were consistently associated with cognition. Conclusions Below average cognitive performance is common in this patient group. In addition, a subgroup shows reliable cognitive decline after allogeneic HSCT. Healthcare professionals should be aware of these treatment-related cognitive side effects. Copyright © 2012 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Abstract: Objective: The possible association between neuropsychological impairment, self-perceived cognitive deficits, fatigue and health related quality of life has been studied in high-risk breast cancer survivors 5 years following standard adjuvant (n =23) versus high-dose chemotherapy (n =24) and in early-stage breast cancer patients (n =29) (comparison group) following radiation therapy. Methods: A neuropsychological assessment covering attention, memory and executive functions was used together with the questionnaire for self-perceived deficits in attention (FEDA), the multidimensional fatigue inventory (MFI-20) and the EORTC-QLQ-C30. Results: Findings have shown that neuropsychological impairment is not directly associated with self-perceived cognitive deficits, fatigue and HRQOL. However, 46% of patients reported self-perceived cognitive deficits and 82% of the patients complained about cancer related fatigue. Except for reduced activity we did not find significant group differences, even though patients who received standard-dose chemotherapy had consistently higher levels of self-perceived cognitive deficits and fatigue, and the lowest HRQOL. Conclusion: Results emphasize the need for psychosocial counseling and support during treatment phase and follow up care as well. Sensitive cancer-specific measures for the assessment of self-perceived cognitive deficits in different cognitive domains according to neuropsychological measurements are required. Practice implications: The role of self-perceived cognitive deficits and fatigue should be considered in educational interventions and counseling. Specific rehabilitation measures should be developed, implemented and evaluated in order to meet the needs of these patients and to decrease the frequency of cognitive deficits following cancer treatment. [Copyright &y& Elsevier]

Objectives. To determine the positive and detrimental aspects of social support prior to allogeneic or autologous bone marrow transplantation/stem cell transplantation. Design. Cross-sectional. Methods. Patients completed the German version of the Illness-specific Social Support Scale (ISSS) and the Quality of Life (QoL) Questionnaire Core 30 (EORTC QLQ-C30). Results. Participants were 282 patients (62% autologous SCT, 39% women, 97% haematological malignancies, 72% with partner).We found satisfactory reliability values for both ISSS scales: positive support (Cronbach's α = .91) and problematic support (= .73). Patients living with a partner displayed higher scores in positive interaction than patients living alone (p < .001). Analysis showed a significant main effect of partnership, p < .001; F(1) = 8:345, and better scores for women, p < 1; F(1) = 2.758. Furthermore, we determined a negative correlation between problematic interaction and emotional/social function (p < .001) and a positive correlation with insomnia, but no correlation between positive interaction, QLQ-C30, and Karnofsky's index. [ABSTRACT FROM AUTHOR]

Context: Quality of life (QoL) is a central focus of care in advanced cancer. Specialized instruments, such as the Quality of Life at the End of Life-Cancer (QUAL-EC), may be useful to assess psychosocial issues associated with QoL unique to this population.Objectives: To evaluate the measurement of the psychosocial dimensions of QoL using the German translation of the QUAL-EC-Psychosocial (QUAL-EC-P) questionnaire, including factor structure and psychometrics.Methods: About 183 patients with advanced cancer from the University Medical Center Hamburg-Eppendorf and University Medical Center Leipzig completed the QUAL-EC-P questionnaire. We conducted exploratory factor analysis as well as item and reliability analysis. We examined convergent validity with correlations between the scale and relevant psychological constructs.Results: The sample was 60% female with mean age of 57.7 (SD = 11.7). We extracted three factors accounting for 44% of the variance aligning with the structure of the instrument. The QUAL-EC-P questionnaire showed good to acceptable internal consistency for the QoL-psychosocial total score (α = 0.77), the Life completion subscale (α = 0.77), and the Relationship with health care provider subscale (α = 0.81). The Preparation for end of life subscale had adequate albeit low internal consistency (α = 0.64) because concerns about family were less associated with financial worry and fear of death than expected. The psychosocial dimensions of QoL correlated negatively with depression (r = -0.27, P ≤ 0.001), anxiety (r = -0.32, P ≤ 0.001), demoralization (r = -0.63, P ≤ 0.001), and attachment insecurity (r = -0.51, P ≤ 0.001) and positively with spiritual well-being (r = 0.63, P ≤ 0.001).Conclusion: The QUAL-EC-P questionnaire may be used to assess the psychosocial aspects of QoL and promote their clinical discussion in patients with advanced cancer. [ABSTRACT FROM AUTHOR]

Background: Although psycho-oncological interventions have been shown to significantly reduce symptoms of anxiety and depression and enhance quality of life, a substantial number of patients with advanced cancer do not receive psycho-oncological interventions tailored to their individual situation. Given the lack of reliable data on the efficacy of psycho-oncological interventions in palliative care settings, we aim to examine the efficacy of a brief, manualized individual psychotherapy for patients with advanced cancer: Managing Cancer and Living Meaningfully (CALM). CALM aims to reduce depression and death anxiety, to strengthen communication with health care providers, and to enhance hope and meaning in life. We adapted the intervention for German cancer care settings.Methods/design: We use a single-blinded randomized-controlled trial design with two treatment conditions: intervention group (IG, CALM) and control group (CG). Patients in the CG receive a usual non-manualized supportive psycho-oncological intervention (SPI). Patients are randomized between the IG and CG and assessed at baseline (t0), after three (t1) and after 6 months (t2). We include patients with a malignant solid tumor who have tumor stages of III or IV (UICC classification). Patients who are included in the study are at least 18 years old, speak German fluently, score greater than or equal to nine on the PHQ-9 or/and greater than or equal to five on the Distress Thermometer. It is further necessary that there is no evidence of severe cognitive impairments. We measure depression, anxiety, distress, quality of life, demoralization, symptom distress, fatigue as well as spiritual well-being, posttraumatic growth and close relationship experiences using validated questionnaires. We hypothesize that patients in the IG will show a significantly lower level of depression 6 months after baseline compared to patients in the CG. We further hypothesize a significant reduction in anxiety and fatigue as well as significant improvements in psychological and spiritual well-being, meaning and post-traumatic growth in the IG compared to CG 6 months after baseline.Discussion: Our study will contribute important statistical evidence on whether CALM can reduce depression and existential distress in a German sample of advanced and highly distressed cancer patients.Trial Registration: ClinicalTrials.gov NCT02051660. [ABSTRACT FROM AUTHOR]