Digital Therapeutic (Mika) Targeting Distress in Patients With Cancer: Results From a Nationwide Waitlist Randomized Controlled Trial.

BACKGROUND: Distress is highly prevalent among patients with cancer, but supportive care needs often go unmet. Digital therapeutics hold the potential to overcome barriers in cancer care and improve health outcomes. OBJECTIVE: This study conducted a randomized controlled trial to investigate the efficacy of Mika, an app-based digital therapeutic designed to reduce distress across the cancer trajectory. METHODS: This nationwide waitlist randomized controlled trial in Germany enrolled patients with cancer across all tumor entities diagnosed within the last 5 years. Participants were randomized into the intervention (Mika plus usual care) and control (usual care alone) groups. The participants completed web-based assessments at baseline and at 2, 6, and 12 weeks. The primary outcome was the change in distress from baseline to week 12, as measured by the National Comprehensive Cancer Network Distress Thermometer. Secondary outcomes included depression, anxiety (Hospital Anxiety and Depression Scale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and quality of life (Clinical Global Impression-Improvement Scale). Intention-to-treat and per-protocol analyses were performed. Analyses of covariance were used to test for outcome changes over time between the groups, controlling for baseline. RESULTS: A total of 218 patients (intervention: n=99 and control: n=119) were included in the intention-to-treat analysis. Compared with the control group, the intervention group reported greater reductions in distress (P=.03; ηp²=0.02), depression (P<.001; ηp²=0.07), anxiety (P=.03; ηp²=0.02), and fatigue (P=.04; ηp²=0.02). Per-protocol analyses revealed more pronounced treatment effects, with the exception of fatigue. No group difference was found for quality of life. CONCLUSIONS: Mika effectively diminished distress in patients with cancer. As a digital therapeutic solution, Mika offers accessible, tailored psychosocial and self-management support to address the unmet needs in cancer care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00026038; https://drks.de/search/en/trial/DRKS00026038.

Compliance with medical regimen among hematological cancer patients and its association with symptoms of posttraumatic stress disorder and adjustment disorder.

Background: Hematological cancer patients must comply with extensive medical instructions to prevent cancer progression or relapse. Psychological comorbidities and patient characteristics have been shown to affect compliance. However, the impact of posttraumatic stress disorder (PTSD) and adjustment disorder (AjD) on compliance in cancer patients remains unclear. This study aims to evaluate compliance in hematological cancer patients more comprehensively and to investigate its association with PTSD and AjD symptomatology as well as sociodemographic and medical factors. Methods: Hematological cancer patients were cross-sectionally assessed via validated questionnaires for PTSD (PCL-5) and AjD (ADMN-20), and three internally developed items on compliance with medical regimen, with two referring to compliance behavior and one item assessing perceived difficulties with complying. Each compliance item was analyzed descriptively. Multiple linear regression models tested the association between compliance and PTSD and AjD symptomatology, sociodemographic and medical factors. Results: In total, 291 patients were included (response rate 58%). Nine out of ten patients reported to either never (67%) or rarely (25%) change their medical regimen. However, 8% reported to change it once in a while or often. Compliance behavior was mostly rated as very easy (36%) or easy (45%) to implement. Nevertheless, 19% perceived it to be partly difficult or difficult to follow medical regimen. Symptoms of AjD (ß = 0.31, p < 0.001) were associated with more difficulties to comply. Higher compliance behavior in turn was associated with stem cell transplantation (SCT) treatment (ß = -0.21, p < 0.001) and lower education (ß = -0.19, p = 0.002). Conclusion: Although most patients indicated that they comply with medical regimen, a considerable subgroup of patients indicated subjectively perceived difficulties and thus seem to require additional support in implementing medical instructions possibly through improved medical communication and patient health literacy or shared decision-making.

New progress in an old debate? Applying the DSM-5 criteria to assess traumatic events and stressor-related disorders in cancer survivors.

OBJECTIVE: The rather broad definition of medical trauma within DSM-IV has contributed to long-lasting debates on the applicability of Posttraumatic Stress Disorder (PTSD) in oncological patients and its differentiation from Adjustment Disorder (AjD) which results from non-traumatic critical life events. The DSM-5 criteria have introduced a narrower definition of medical traumatization. However, studies on updated prevalence rates in cancer patients are missing. METHODS: Within a cross-sectional study, we assessed hematological cancer survivors using the Structured Clinical Interview for DSM-5. We investigated (i) the frequency and type of cancer-related stressors, (ii) the proportion of stressors qualifying as traumatic according to DSM-5 (i.e., an event of sudden and catastrophic character) and (iii) the prevalence of PTSD, AjD and cancer-related PTSD according to DSM-5. RESULTS: 291 patients participated (response rate: 58%). Mean age was 54 years, 60% were male. 168 patients (59%) reported cancer-related stressors, with the most frequent being cancer diagnosis disclosure (n = 58, 27%). Eight percent of reported stressors qualified as traumatic events according to DSM-5. Five (1.8%), 15 (5.3%) and 20 (7.0%) cancer survivors met DSM-5 criteria for current PTSD, lifetime PTSD and AjD, respectively. Among all PTSD cases, three were cancer-related (1.1%). In addition, seven patients (2.5%) met all symptoms for cancer-related PTSD, but not the DSM-5 criterion for medical trauma. Considering receiving the cancer diagnosis as traumatic event, which is debatable according to DSM-5, 38% of stressors qualified as traumatic and six patients (2.1%) met criteria for cancer-related PTSD. CONCLUSIONS: DSM-5 criteria enable a clear identification of traumatic events in the context of cancer. This change may inform discussions on the appropriateness of PTSD in cancer patients and facilitates its differentiation from AjD. Larger studies need to validate our findings.

Changes in anxiety in the general population over a six-year period.

BACKGROUND: Anxiety is a frequent condition in patients and in the general population. The aim of this study was to investigate changes in anxiety over time and to test several psychometric properties of the Generalized Anxiety Disorder Screener (GAD-7) from a longitudinal perspective. METHODS: The GAD-7 was included in an examination with two waves, six years apart. The study sample (n = 5355) was comprised of representatively selected adults from the general population with a mean age of 57.3 (SD = 12.3) years. RESULTS: During the 6-year time interval, anxiety increased significantly from 3.28 ± 3.16 (t1) to 3.66 ± 3.46 (t2). Confirmatory factor analyses proved the longitudinal measurement invariance of the GAD-7. Reliability of the GAD-7 was established both for the cross-sectional and the longitudinal perspective. The test-retest correlation was r = 0.53, and there were no substantial sex or age differences in these coefficients of temporal stability. The mean changes in anxiety were similar for males and females, and there was no linear age trend in the changes measured by the GAD-7. Changes in anxiety over the 6-year period were correlated with changes in satisfaction with life (r = -0.30), bodily complaints (r = 0.31), and the mental component of quality of life (r = -0.48). CONCLUSION: The GAD-7 is a suitable instrument for measuring changes in anxiety. Age and gender have only minor significance when interpreting change scores.

Symptoms of posttraumatic stress disorder and adjustment disorder in hematological cancer patients with different treatment regimes.

BACKGROUND: Symptoms of posttraumatic stress disorder (PTSD) and adjustment disorder (AjD) are common in hematological cancer patients as they face severe stressors during their serious disease and often intensive treatment, such as stem cell transplantation (SCT). Aims of the present study were to provide frequency and risk factors for PTSD and AjD based on updated diagnostic criteria that are lacking to date. MATERIAL AND METHODS: In a cross-sectional study, hematological cancer patients were assessed for stressor-related symptoms via validated self-report questionnaires based on updated criteria for PTSD (PCL-5) and AjD (ADMN-20). Frequency and symptom severity were estimated among the total sample and SCT subgroups (allogeneic, autologous, no SCT). SCT subgroups were compared using Chi-squared-tests and ANOVAs. Linear regression models investigated sociodemographic and medical factors associated with symptomatology. RESULTS: In total, 291 patients were included (response rate: 58%). 26 (9.3%), 66 (23.7%) and 40 (14.2%) patients met criteria for cancer-related PTSD, subthreshold PTSD and AjD, respectively. Symptom severity and frequency of criteria-based PTSD and AjD did not differ between SCT subgroups (all p > 0.05). Factors associated with elevated symptomatology were younger age (PTSD: p < 0.001; AjD: p = 0.02), physical comorbidity (PTSD: p < 0.001; AjD: p < 0.001) and active disease (PTSD: p = 0.12; AjD: p = 0.03). CONCLUSION: Based on new criteria, a considerable part of hematological cancer patients reports PTSD and AjD symptoms. Younger patients and patients with physical symptom burden might be particularly at risk and need to be monitored closely to enable effective treatment at an early stage.

Prevalence of mental disorders, psychosocial distress, and perceived need for psychosocial support in cancer patients and their relatives stratified by biopsychosocial factors: rationale, study design, and methods of a prospective multi-center observational cohort study (LUPE study).

Background: Despite remarkable progress, cancer remains a life-threatening disease for millions of people worldwide, also resulting in significant psychosocial limitations. High-quality, comprehensive cancer care requires patient and family involvement and the provision of needs-based, targeted psychosocial services. Although progress has been made in understanding the occurrence of mental comorbidity and psychosocial distress in cancer patients, comparatively little is known about the course of psychological comorbidity and psychosocial distress in early survivorship among patients and their families. We therefore aim to estimate the prevalence of mental disorders according to the DSM-5, psychosocial distress, perceived needs for psychosocial support and utilization of psychosocial support offers in newly diagnosed cancer patients and their relatives, taking into account potential contributing biopsychosocial factors for the occurrence of psychological comorbidity. Methods/design: This study follows a prospective multi-center observational cohort design across four measurement time points: within 2 months after cancer diagnosis (t1), and in the follow-up period at 6 months (t2), at 12 months (t3), and at 18 months (t4) after t1. Patients older than 18 years who have a confirmed initial diagnosis of a malignant solid tumor and are scheduled for cancer treatment at one of the participating cancer centers are eligible for study participation. Relatives of eligible patients are also eligible for study participation if they are older than 18 years. Patients are interviewed using the Structured Clinical Interview for DSM-5 Disorders (SCID-5-CV). In addition, patients and relatives receive a set of validated questionnaires at each measurement time point, covering comorbid conditions and functional performance, perceived psychological distress and quality of life, partnership aspects and social relationships, supportive care needs and use of psychosocial support services, health literacy, and health behavior and meaning in life. Discussion: This prospective multi-center observational cohort study has a major focus on increasing quality of care and quality of life in cancer survivors through providing rigorous longitudinal data for the development and implementation of target group-specific psychosocial support services. Trial registration: NCT04620564, date of registration 9/11/2020; DKG OnkoZert: Registrier-No.: ST-U134, date of registration 5/11/2021.

[Impact of Oncological Treatment on Perceived Stigmatization - A Register-Based Study]. / Der Zusammenhang zwischen onkologischen Therapien und wahrgenommener Stigmatisierung bei Krebspatienten mit Brust-, Darm-, Lungen-und Prostatakrebs ­ Ergebnisse einer registerbasierten Studie.

BACKGROUND: Studies on stigmatization of cancer patients show a moderate or high relevance of perceived stigmatization. To date, there are no studies with explicit focus on stigma in relation to oncological therapy. We investigated the role of oncological therapy on perceived stigma in a large sample. METHODS: Quantitative data from 770 patients (47,4% women; 88%≥50 years) with breast, colorectal, lung, or prostate cancer were analyzed as part of a registry-based bicentric study. Stigma was assessed with the German version of the SIS-D; the validated instrument includes four subscales in addition to a total score. Data were analyzed using the t-test and multiple regression with various sociodemographic and medical predictors. RESULTS: Of the 770 cancer patients, 367 (47,7%) received chemotherapy, possibly in combination with other therapy (surgery, radiotherapy). All stigma scales showed significant mean differences (effect sizes up to d=0,49) with higher scores for patients receiving chemotherapy. The multiple regression analyses of the respective SIS-scales demonstrate a significant influence of the variables age (ß≤- 0,266) and depressivity (ß≤0,627) on perceived stigma in all five models, and (in four models) a significant influence of the variable chemotherapy (ß≤0,140). Radiotherapy shows only a weak influence in all models and surgery has no relevance. The explained variance ranges from R2=27 to 46,5%. DISCUSSION AND CONCLUSION: The findings support the assumption of an association of oncological therapy, especially chemotherapy, on the perceived stigmatization of cancer patients. Relevant predictors are depression and younger (<50) age. These (vulnerable) groups should therefore receive special attention and psycho-oncological care in clinical practice. Further research on the course and mechanisms of therapy-related stigmatization is also necessary.

Interconnectivity of fear of progression and generalized anxiety - Network analysis among a sample of hematological cancer survivors.

PURPOSE: Fear of cancer progression and recurrence (FoP) and generalized anxiety disorder (GAD) are syndromes commonly seen in cancer patients. This study applied network analysis to investigate how symptoms of both concepts are interconnected. METHODS: We used cross-sectional data from hematological cancer survivors. A regularized Gaussian graphical model including symptoms of FoP (FoP-Q) and GAD (GAD-7) was estimated. We investigated (i) the overall network structure and (ii) tested on pre-selected items whether both syndromes could be differentiated based on their worry content (cancer related vs. generalized). For this purpose, we applied a metric named bridge expected influence (BEI). Lower values mean that an item is only weakly connected with the items of the other syndrome, which can be an indication of its distinctive characteristic. RESULTS: Out of 2001 eligible hematological cancer survivors, 922 (46%) participated. The mean age was 64 years and 53% were female. The mean partial correlation within each construct (GAD: r = .13; FoP: r = .07) was greater than between both (r = .01). BEI values among items supposed to discriminate between the constructs (e.g., worry about many things within GAD and fear not to endure treatment within FoP) were among the smallest so our assumptions were confirmed. CONCLUSIONS: Our findings based on the network analysis support the hypothesis that FoP and GAD are different concepts within oncology. Our exploratory data needs to be validated in future longitudinal studies.

Prevalence and severity of anxiety in cancer patients: results from a multi-center cohort study in Germany.

PURPOSE: Anxiety is an accompanying symptom in cancer patients that can have a negative impact on patients. The aim of the present analyses is to determine the prevalence of anxiety, taking into account sociodemographic and medical variables, and to determine the odds ratio for the occurrence of anxiety in cancer patients compared to general population. METHODS: In this secondary analyses, we included 4,020 adult cancer patients during and after treatment from a multi-center epidemiological study from 5 regions in Germany in different treatment settings and a comparison group consisting of 10,000 people from the general population in Germany. Anxiety was measured with the Generalized Anxiety Disorder (GAD-7) questionnaire. In multivariate analyses adjusted for age and sex, we calculated the odds of being anxious. RESULTS: The prevalence of anxiety was observed to be 13.8% (GAD-7 ≥ 10). The level of anxiety was significant higher for patients in rehabilitation, compared to patients during inpatient and outpatient treatment (p = .013). Comparison with the general population yielded a 2.7-fold increased risk for anxiety among cancer patients (95% CI 2.4-3.1; p < .001). Patients with bladder cancer (OR, 5.3; 95% CI 3.0-9.4) and testicular cancer (OR, 5.0; 95% CI 2.1-12.1) showed the highest risk of having high levels of anxiety. CONCLUSION: The results highlight the importance of identifying anxiety in cancer patients.

Web-Based Cognitive-Behavioral Therapy to Reduce Severe Cancer-Related Fatigue Among Survivors of Hodgkin Lymphoma: A Feasibility Study.

We investigated the feasibility of a web-based cognitive-behavioral therapy to reduce cancer-related fatigue (CRF) among survivors of Hodgkin lymphoma. In this before-and-after trial, patients were primarily recruited via the German Hodgkin Study Group (GHSG). We assessed feasibility (response and drop-out rate) and preliminary efficacy including CRF, quality of life (QoL), and depressive symptomatology. T tests compared baseline levels with t1 (post treatment) and t2 (3 months of follow-up). Among 79 patients contacted via the GHSG, 33 provided interest (42%). Among the seventeen participants, four were treated face-to-face (pilot patients), 13 underwent the web-based version. Ten patients completed the treatment (41%). Among all participants, CRF, depressive symptomatology, and QoL improved at t1 (p ≤ .03). The effect in one of the CRF measures remained at t2 (p = .03). Except for QoL, post-treatment effects were replicated among the completers of the web-based version (p ≤ .04). The potential for this program has been demonstrated, but needs to be re-assessed after identified issues on feasibility have been resolved.Trial registration: The study was registered at ClinicalTrials.gov (Number: NCT03968250).

Effect of depression, anxiety, and distress screeners on the need, intention, and utilization of psychosocial support services among cancer patients.

PURPOSE: In clinical cancer care, distress screening is recommended to identify highly burdened patients in objective need for psychosocial support to improve psychological distress and quality of life and to enhance patient empowerment. It is however unclear whether distress screeners are suitable for psychosocial care planning and thus whether they can predict the willingness that is need, intention, and utilization, to seek psychosocial support. METHODS: In a secondary analysis of a cluster intervention study, we assessed cancer patients with three distress screeners (DT, PHQ-9, GAD-7) at baseline. The willingness to seek psychosocial support services was assessed binary for psychosocial services at 3 and 6 months. Logistic regression models were applied to examine the predictive effect of the screeners on need, intention, and utilization. We corrected all models for multiple testing. RESULTS: The 660 patients included in the study were on average 60 years, 54% were male. At the 3- and 6-month follow-up, 353 and 259 patients participated, respectively. The screeners were best in predicting the need for support (OR reaching up to 1.15, 1.20, and 1.22 for the PHQ-9, GAD-7, and DT respectively). The intention was predicted by the PHQ-9 and GAD-7, whereas utilization of psychosocial support services was not predicted by the screeners. CONCLUSION: The three distress screeners might be useful in psychosocial care planning, as they are able to predict the need and to some degree the intention to seek psychosocial support. Future research needs to examine potential barriers and supporting factors that may explain utilization of psychosocial support. TRIAL REGISTRATION: The study was retrospectively registered (2/2021) at ClinicalTrials.gov (number: NCT04749056).

The German version of the body image scale: Validation and item response analysis in cancer patients.

OBJECTIVE: To translate the cancer-specific Body Image Scale (BIS) into German and assess its psychometric properties. METHODS: The BIS was translated in accordance with current guidelines. In a prospective, cross-sectional two center study (psychosocial counselling center for cancer patients Leipzig, oncological inpatient ward Berlin), we assessed composite reliability and factor structure using confirmatory factor analysis. Additional item response theory (IRT) modelling was performed. Convergent validity was assessed via correlation with the Body Appreciation Scale (BAS) as well as psychological symptom burden (PHQ-9, GAD-2 and Distress Thermometer). Discriminant validity was assessed via demographic and clinical group comparisons. RESULTS: 677 patients participated (response rate 78%). Composite reliability was 0.95 and the one-factor structure was confirmed (standardized root mean square residual = 0.051, average variance extracted ≥50%, no indications of local dependence). In IRT models, all items had a discriminating power above the established threshold of b = 0.5 and relatively high "difficulty" parameters (b = 0.89-2.06). The BIS was negatively correlated with the BAS (rho = -0.62, p < 0.001) and positively with psychological symptom burden (e.g. PHQ-9: rho = 0.49, p < 0.001). Patients who were younger, female, had undergone chemotherapy, radiotherapy or surgery and those who were distressed by fatigue, their appearance or sexual problems had significantly higher BIS scores. CONCLUSION: The German version of the BIS is a valid tool to assess BID in patients with cancer that is now available for clinical or research contexts.

Partnership, sexuality, and fertility-related communication: findings from a register-based study among long-term hematological cancer survivors.

PURPOSE: Even though the number of hematological cancer survivors suffering from long-term and late consequences of their disease is growing, knowledge about their situation regarding partnership, sexuality, and fertility-related communication is sparse to date. METHODS: We recruited survivors of hematological malignancies (≥ 3 years after diagnosis) from two cancer registries in Germany. We applied validated instruments and study-specific items on satisfaction with partnership, sexual functioning, and fertility-related communication with physicians. We provided descriptive statistics and conducted multiple regression analyses to identify associations of the outcomes with patient factors and well-being (anxiety, depression, and quality of life). RESULTS: Of 2001 eligible survivors, 922 (46%) participated. Fifty-seven percent were male, and the mean age was 64 years. Ninety percent and 60% reported to be satisfied with their partnership and sexual life, respectively. However, 81% and 86% reported being sexually impaired by physical or mental symptoms, respectively. Seventy-four percent of those with incomplete family planning had a fertility-related conversation with a physician. Female gender (p < .05, Beta = - .09), older age (p < .01, Beta = .10), and chemotherapy (p < .01, Beta = .10) were associated with less sexual pleasure caused by physical impairment. Satisfaction with partnership (p < .001, Beta = .22), satisfaction with sexual life (p < .001, Beta = .28), and conversation about fertility (p < .05, Beta = .26) were associated with better quality of life. CONCLUSION: Even though long-term survivors seem to be generally satisfied with their partnership and sexual life, they may suffer from specific impairments. Our findings need to be verified in longitudinal studies.

[Survivorship care plans for cancer patients: the importance of risk stratification, self-management and health literacy in the age of digital care]. / Survivorship-Care-Programme für Krebspatienten: die Bedeutung von Risikostratifizierung, Selbstmanagement- und Gesundheitskompetenzen im Zeitalter digitaler Versorgung.

Due to an ageing population and improved early cancer detection, medical diagnostics and oncological treatment, the number of patients who are cured or live with the disease for a long time (cancer survivors) is increasing rapidly in Germany, as in all other industrialised countries worldwide. For many patients, living with and after cancer means living with physical and psychosocial disease and treatment-related long-term and late effects. In view of demographic change, rising cancer prevalence and medical progress, one of the urgent questions is how to ensure high-quality individualised and at the same time affordable cancer care for ageing patients with multimorbidity.In addition to strengthening cancer prevention, these developments require research and implementation of individualised aftercare within the framework of survivorship care plans (SCPs). The overarching goal of SCPs is to prevent or minimise the physical and psychosocial long-term and late effects, reduce mortality and improve the patients' quality of life. The evidence on the effectiveness of SCPs in improving patient-reported endpoints is so far not clear. The provision of tailored information as well as risk-modifying and demand-orientated offers based on risk stratification are seen as central components in the implementation of SCPs. In this context, the promotion of self-management and health literacy of patients also take on a high priority against the background of the increase in digital health applications.

Attitudes toward a COVID-19 vaccine and vaccination status in cancer patients: a cross-sectional survey.

PURPOSE: We aim to assess attitudes toward a COVID-19 vaccine and vaccination status in cancer patients and to explore additional factors such as the level of information and comprehensibility and accessibility of this information, anxiety symptoms in general and toward COVID-19, and general health literacy. METHODS: We included 425 outpatients (mean age 61.4, age range 30-88 years, 60.5% women) of the Psychosocial Counseling Center for Cancer patients of the Department of Medical Psychology and Medical Sociology, Leipzig. We recorded attitudes toward a COVID-19 vaccine and vaccination status via self-report. The impact of psychosocial factors, including anxiety (GAD-7), COVID-19-specific anxiety (OCS; FCV-19S) and health literacy (HLS-EU-Q16) were analyzed with point-biserial correlations using Pearson's r. RESULTS: We found that the vast majority (95.5%) reported being vaccinated against COVID-19 and that overall trust in safety and protective effects of a COVID-19 vaccine was high (90.9%). The vaccination readiness among nonvaccinated cancer survivors was low to very low with "fear of side effects" the most mentioned (72.2%) reason against a COVID-19 vaccine. There was no significant correlation between vaccination status and fear or anxiety symptomatology, and health literacy. Obsessive thoughts about COVID-19 was significantly higher in nonvaccinated cancer patients. CONCLUSIONS: Majority of respondents are positive about COVID-19 vaccine, accompanied by a very high rate of COVID-19 immunization in our sample. Further studies with a larger sample of nonvaccinated cancer patients should further investigate the relationship on fear and vaccination hesitancy and align communication strategies accordingly.

The association between sleep problems and general quality of life in cancer patients and in the general population.

Objective: It is well-known that patients with cancer frequently experience sleep problems, and that sleep quality is associated with general quality of life (QoL). The aims of this study were to analyze the relationship between sleep problems and other components of QoL in more detail and to investigate sex and age differences in sleep quality in cancer patients in comparison with the general population. Method: This study comprised one general population sample (n = 4,476) and eight samples with cancer patients (n between 323 and 4,020). Sleep Quality was measured using the QoL questionnaire EORTC QLQ-C30. Results: All of the cancer patient groups reported more sleep problems than the general population. Sleep problems were associated with all facets of QoL both in cancer patients and in the general population. The highest associations were found in cancer patients for fatigue (r = 0.52) and emotional functioning (r = -0.47). The association between sleep quality and general QoL was lower in the cancer samples (r = -0.37) than in the general population (r = -0.46). Female cancer patients reported markedly more sleep problems than male patients did (d = 0.45), while this sex difference was lower in the general population (d = 0.15). In contrast to the general population, younger cancer patients had greater trouble sleeping than older patients did (d = -0.17). Conclusion: The results underline the significance of the role mental factors play in sleep problems. Health care providers should pay special attention to female patients and younger patients concerning this issue.

Evaluation of an electronic psycho-oncological adaptive screening program (EPAS) with immediate patient feedback: findings from a German cluster intervention study.

PURPOSE: Distress screening has become mandatory and essential in comprehensive cancer care. We evaluated an electronic psycho-oncological adaptive screening (EPAS) which assesses objective indicators of care needs and subjectively perceived care needs and subsequently provides patient feedback with individualized recommendations about psychosocial care services. METHODS: Patients were assessed within clusters, i.e., different oncological facilities of the competence network of the University Cancer Center Hamburg (UCCH). Patients in the intervention arm underwent the screening, controls received standard care. Patients were assessed at baseline (t0), 3-month (t1), and 6-month (t2) follow-up. Outcomes included information level and use of/access to nine psychosocial services at UCCH, well-being (GAD-7, PHQ-9, SF-8), and treatment satisfaction (SCCC). Conditional linear and logistic regressions were used to identify screening effects at t1 and t2. RESULTS: Of 1320 eligible patients across 11 clusters, 660 were included (50%). The average age was 60 years; 46% were female. The intervention was associated with increased information level for all psychosocial services at t1 and t2 (all p < .001), increased use in some of these services at t1 and t2, respectively (p ≤ .02), and better evaluation of access (e.g., more recommendations for services provided by physicians, p < .01). At t2, the intervention was associated with a lower level of satisfaction with disease-related information (p = .02). CONCLUSIONS: EPAS may improve information about psychosocial services as well as utilization of and access to these services. The effect on information level seems not to be generalizable to other aspects of oncological care. Future studies should incorporate novel technologies and condense the procedure to its core factors. IMPLICATIONS FOR CANCER SURVIVORS: The screening may help to enhance self-management competencies among cancer survivors. TRIAL REGISTRATION: The trial was retrospectively registered (2/2021) at ClinicalTrials.gov (number: NCT04749056).

Psychometric Evaluation of the German Version of the Demoralization Scale-II and the Association Between Demoralization, Sociodemographic, Disease- and Treatment-Related Factors in Patients With Cancer.

Objective: To test the psychometric properties, internal consistency, dimensional structure, and convergent validity of the German version of the Demoralization Scale-II (DS-II), and to examine the association between demoralization, sociodemographic, disease- and treatment-related variables in patients with cancer. Methods: We recruited adult patients with cancer at a Psychosocial Counseling Center and at oncological wards. Participants completed the 16-item DS-II, Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder Screener-2 (GAD-2), Distress Thermometer (DT), and Body Image Scale (BIS). We analyzed internal consistency of the DS-II using Cronbach's Alpha (α). We tested the dimensional structure of the DS-II with Confirmatory Factor Analyses (CFA). Convergent validity was expressed through correlation coefficients with established measures of psychological distress. The associations between demoralization, sociodemographic, disease- and treatment-related variables were examined with ANOVAs. Results: Out of 942 eligible patients, 620 participated. The average DS-II total score was M = 5.78, SD = 6.34, the Meaning and Purpose subscale M = 2.20, SD = 3.20, and the Distress and Coping Ability subscale M = 3.58, SD = 3.45. Internal consistency ranged from high to excellent with α = 0.93 for the DS-II total scale, α = 0.90 for the Meaning and Purpose subscale, and α = 0.87 for the Distress and Coping Ability subscale. The one-factor and the two-factor model yielded similar model fits, with CFI and TLI ranging between 0.910 and 0.933, SRMR < 0.05. The DS-II correlated significantly with depression (PHQ-9: r = 0.69), anxiety (GAD-2: r = 0.72), mental distress (DT: r = 0.36), and body image disturbance (BIS: r = 0.58). High levels of demoralization were reported by patients aged between 18 and 49 years (M = 7.77, SD = 6.26), patients who were divorced/separated (M = 7.64, SD = 7.29), lung cancer patients (M = 9.29, SD = 8.20), and those receiving no radiotherapy (M = 7.46, SD = 6.60). Conclusion: The DS-II has very good psychometric properties and can be recommended as a reliable tool for assessing demoralization in patients with cancer. The results support the implementation of a screening for demoralization in specific risk groups due to significantly increased demoralization scores.

Frequency of Sexual Problems and Related Psychosocial Characteristics in Cancer Patients-Findings From an Epidemiological Multicenter Study in Germany.

BACKGROUND: Multimodal cancer treatments are often associated with sexual problems. Identifying patients with sexual problems could help further elucidate serious issues with their sexuality and thus promote or maintain patients' sexual health. We aimed to assess the occurrence of sexual problems in patients across different tumor locations and to explore associated sociodemographic, medical and psychosocial factors. METHODS: We included 3,677 cancer patients (mean age 58 years, age range 18-75 years, 51.4% women) from a large epidemiological multicenter study in Germany on average 13.5 months after cancer diagnosis. The occurrence and frequency of sexual problems were assessed via a binary item on the problem checklist of the Distress Thermometer (DT). Controlled associations of these problems with sociodemographic, medical and psychosocial factors including distress (DT), anxiety (GAD-7), depression (PHQ-9), quality of life (EORTC-QLQ-C30), and social support (SSUK-8) are analyzed using logistic regression analysis. RESULTS: We found that 31.8% of patients reported sexual problems, with a significant higher proportion in men (40.5%) compared to women (23.7%), OR 2.35, 95% CI [1.80-3.07] and a higher proportion in patients with a partner (35.6%) compared to those without a partner (3.5%), OR 2.83, 95% CI [2.17-3.70]. Tumor location was associated with occurrence of sexual problems: patients with cancer, affecting the male genital organs had the highest chance for sexual problems, OR 2.65, 95% CI [1.18-3.95]. There was no significant difference in the occurrence of sexual problems between age groups OR 0.99, 95% CI [2.13-3.53] and type of therapy (e.g., operation OR 0.91, 95% CI [0.72-1.15]). Sexual problems were further associated with elevated levels of anxiety, OR 1.05, 95% CI [1.02-1.10], less social support, OR 0.93, 95% CI [0.90-0.97] and lower quality of life in terms of impaired functioning (e.g., social function, OR 0.99, 95% CI [0.99-1.00]). CONCLUSIONS: Sexual problems are commonly reported by patients. Male patients and those living with a partner are more likely to report sexual problems. Sexual problems are associated with different aspects of well-being. The findings imply the practical relevance to screen for sexual problems among patients and identified groups that should be particularly monitored.