Psychosocial distress and psychosocial resources in couples facing non-melanoma skin cancers and malignant melanoma.

BACKGROUND: Skin cancer is the most common cancer worldwide and comprises various non-melanoma skin cancer (NMCS) diagnoses and malignant melanoma (MM). It places a psychological burden on patients and their spouses. The present study aims to investigate psychological distress, temporal changes of psychosocial resources (PR), as well as dyadic dynamics of psychological distress and PR in patients with NMSC or MM and their spouses. METHODS: Fifty-four heterosexual couples with different skin cancers, diagnosed within the previous 12 months, participated in this quantitative cross-sectional study. Patients and spouses provided information about depression and anxiety (Hospital Anxiety and Depression Scale), PR within the last four weeks and last three years (Essen Resource Inventory), and partnership quality (Partnership Questionnaire, short version). Dyadic dynamics were analyzed with multiple regression analyses. RESULTS: We found similar distress levels in patients and spouses, as well as in patients with different skin cancers. Spouses from patients with MM reported significant higher distress levels than spouses from patient with NMSC. Patients' depression predicted spouses' depression, and spouses' anxiety predicted patients' anxiety. In patients, we found associations between personal resources (within the last four weeks and three years) and depression, and an association between patients' social resources (within the last three years) and spouses' depression. CONCLUSIONS: The psychological interdependencies between patients' and spouses' depression and anxiety highlight the importance of considering psychological distress in patients with different skin cancers from a dyadic perspective in clinical contexts. Further, personal resources were indicated as a "distress buffer" for patients' mental health. Our results underline the importance of couple interventions that activate PR in patients with cancer and their spouses.

Adherence to Dietary Behavior Recommendations Moderates the Effect Between Time Since Metabolic and Bariatric Surgery and Percentage Total Weight Loss.

PURPOSE: Metabolic and bariatric surgery (MBS) is the gold standard in treating severe obesity. Previous research implies that different psychological and behavior-related factors might be critical for MBS' sustained success. Yet adherence to dietary behavior recommendations and its impact on weight development is rarely examined. This study investigated the relationship between adherence to dietary behavior recommendations and the percentage of total weight loss (%TWL) after MBS. MATERIALS AND METHODS: This study is a cohort study (acquisition in Germany). N = 485 patients after MBS, being in grade III of obesity (body mass index (BMI) ≥ 40 kg/m2) pre-MBS, were included. Participants answered a standardized assessment on the relevant constructs, including adherence to dietary behavior recommendations, depression symptoms, weight, diet, and MBS characteristics. RESULTS: BMI pre-MBS, type of MBS, age, regularity of physical activity, and depression symptoms were identified as significant covariates of %TWL and adherence. Within 6 months after MBS, adherence seems to peak, F(5,352) = 12.35, p < .001. Adherence and time since MBS predict %TWL. A higher adherence (moderator) is related to a higher %TWL, R2 = 52.65%, F(13,344) = 31.54, p < .001. CONCLUSION: After MBS, adherence to dietary behavior recommendations seems crucial for maximizing its success. Implications for the optimization of MBS' success in aftercare management arise. In particular, behavior modification interventions should be routinely implemented.

How do mindfulness-based interventions promote coping and self-efficacy in patients with cancer: A systematic review of qualitative and quantitative data.

OBJECTIVE: The purpose of this study was to review the existing quantitative and qualitative evidence regarding how mindfulness-based interventions (MBIs) help cope with cancer-related challenges and increase affected patients' perceived self-efficacy. METHODS: A systematic literature search was conducted on PubMed, PsycInfo, PubPsych, and CINAHL. Quantitative, qualitative, and mixed methods studies were included if they (1) evaluated MBIs (2) for patients with cancer or cancer survivors (3) regarding their impact on coping with cancer and perceived self-efficacy. The reports were screened by two independent reviewers and conflicts were resolved by a third reviewer. The review was pre-registered on PROSPERO (CRD42022368765). RESULTS: Findings from 28 reports of 19 quantitative studies, six qualitative studies, and three mixed-methods studies (total N = 1722) were extracted and integrated. The synthesis of quantitative data showed considerable heterogeneity in outcomes and measurement instruments. Most often reported were significant positive impacts of mindfulness on general coping skills, self-regulation, and perceived efficacy in coping with cancer. Qualitative interviews with patients supported those results. The three meta-themes identified were that MBI (1) provided patients with tools to use in stressful situations, (2) promoted a general change of mindset and (3) created a feeling of social connectedness. CONCLUSIONS: The reviewed studies suggest that MBI can promote coping and enhance the perceived self-efficacy of patients with cancer. In the future, more research investigating the different aspects of coping and the potentially moderating role of self-efficacy could provide further insights with respect to how coping and self-efficacy related to MBI.

12-Month Trajectories of Health-Related Quality of Life Following Hospitalization in German Cancer Centers-A Secondary Data Analysis.

Patient-reported outcomes (PROs) offer a diverse array of potential applications within medical research and clinical practice. In comparative research, they can serve as tools for delineating the trajectories of health-related quality of life (HRQoL) across various cancer types. We undertook a secondary data analysis of a cohort of 1498 hospitalized cancer patients from 13 German cancer centers. We assessed the Physical and Mental Component Scores (PCS and MCS) of the 12-Item Short-Form Health Survey at baseline (t0), 6 (t1), and 12 months (t2), using multivariable generalized linear regression models. At baseline, the mean PCS and MCS values for all cancer patients were 37.1 and 44.3 points, respectively. We observed a significant improvement in PCS at t2 and in MCS at t1. The most substantial and significant improvements were noted among patients with gynecological cancers. We found a number of significant differences between cancer types at baseline, t1, and t2, with skin cancer patients performing best across all time points and lung cancer patients performing the worst. MCS trajectories showed less pronounced changes and differences between cancer types. Comparative analyses of HRQoL scores across different cancer types may serve as a valuable tool for enhancing health literacy, both among the general public and among cancer patients themselves.

Evaluation of the e-Mental Health Intervention Make It Training From Patients' Perspectives: Qualitative Analysis Within the Reduct Trial.

BACKGROUND: Make It Training is an e-mental health intervention designed for individuals with cancer that aims to reduce psychological distress and improve disease-related coping and quality of life. OBJECTIVE: This study evaluated the experienced usefulness and usability of the web-based Make It Training intervention using a qualitative approach. METHODS: In this study, semistructured interviews were conducted with participants at different cancer stages and with different cancer entities. All participants had previously taken part in the Reduct trial, a randomized controlled trial that assessed the efficacy of the Make It Training intervention. The data were coded deductively by 2 independent researchers and analyzed iteratively using thematic codebook analysis. RESULTS: Analysis of experienced usefulness resulted in 4 themes (developing coping strategies to reduce psychological distress, improvement in quality of life, Make It Training vs traditional psychotherapy, and integration into daily life) with 11 subthemes. Analysis of experienced usability resulted in 3 themes (efficiency and accessibility, user-friendliness, and recommendations to design the Make It Training intervention to be more appealing) with 6 subthemes. Make It Training was evaluated as a user-friendly intervention helpful for developing functional coping strategies to reduce psychological distress and improve quality of life. The consensus regarding Make It Training was that it was described as a daily companion that integrates well into daily life and that it has the potential to be routinely implemented within oncological health care either as a stand-alone intervention or in addition to psychotherapy. CONCLUSIONS: e-Mental health interventions such as Make It Training can target both the prevention of mental health issues and health promotion. Moreover, they offer a cost-efficient and low-threshold option to receive psycho-oncological support.

Efficacy of eHealth interventions to reduce depression symptoms in individuals with obesity: a systematic review of randomized controlled trials.

Introduction: Obesity and depression are inter-related health concerns, demanding a high level of treatment and costs in the health care system. The development of eHealth interventions that simultaneously address obesity and mental health can be supportive in this regard. However, evidence of the efficacy of eHealth interventions in the treatment of depression symptoms in individuals with obesity is lacking. The aim of this systematic literature review is to evaluate the efficacy of existing eHealth interventions for individuals with obesity that target depression symptoms. Methods: We systematically searched electronic databases (Cochrane Library, PubMed, Scopus) to identify studies published in English between January 2016 and January 2023, that focused on eHealth interventions, targeting depression symptoms in individuals with obesity people. Exclusion criteria were study objectives that (1) focused specifically on one or more metabolic comorbidities of individuals with obesity, e.g., hypertension, hyperlipidemia, diabetes; (2) focused specifically on eating disorders comorbidities e.g., binge eating disorder, and (3) focused specifically on patients before or after bariatric surgery. Results: The database search identified 214 records. Six articles were included in this review. Sample sizes ranged from 70 to 1267 participants of ages 18-60 years. All included studies were randomized controlled trials. Two of the six included studies were web-based interventions guided either by medical doctors or psychologists. All interventions included video, printed materials, and interactive parts of which two studies integrated elements of Cognitive Behavioural Therapy and Social Cognitive Therapy. The findings showed that eHealth treatment services, supported and guided throughout the intervention had high acceptance and efficacy in the reduction of depression symptoms among individuals with obesity. Conclusion: EHealth interventions that address and target both mental and physical health with interactive strategies calls for better efficacy in the reduction of depression symptoms. Future eHealth interventions that target depression symptoms in individuals with obesity should integrate digital strategies that address both mental and physical health through interactive modules.

An e-mental health intervention to reduce depression symptoms in individuals with obesity: study protocol for the randomized, controlled, two-armed, confirmatory LightMood trial.

BACKGROUND: Patients with obesity often experience psychological distress, specifically depression symptoms. Due to various barriers, such as limitations of healthcare offers, digital interventions, for example medical apps, can provide a suitable approach to support affected people. In the envisaged prospective randomized controlled trial, we aim to examine the efficacy of the LightMood intervention. The LightMood intervention is a manualized and user-centered, digital intervention for patients with obesity, with a duration of 4 months, which contains elements of cognitive behavioral therapy and mindfulness-based and skills-based exercises. We expect the LightMood intervention to be superior to treatment as usual (TAU) in terms of reducing depression symptoms. METHODS: The trial incorporates four distinct measurement time points: the baseline assessment, the post-treatment assessment, and 1- and 3-month follow-up assessments. Furthermore, we implemented in-treatment assessments for both groups. Participants will be randomized into two groups (LightMood intervention vs TAU). The aim is to include 128 participants (64 per group) in the study. Inclusion criteria are patients who are obese, at least 18 years old, with a private Internet access, and with adequate digital literacy and show depression symptoms (PHQ ≥ 10). Exclusion criteria are weekly outpatient individual psychotherapy, obesity surgery within the last year or planned within the next 7 months, no private Internet access, and the prescription of a new psychotropic drug within the last 2 weeks. The primary outcome is the post-assessment reduction in depression symptoms. Secondary outcomes will include the improvement in self-efficacy, quality of life, mindfulness, reduction in eating disorder symptoms, and body mass index (BMI). Furthermore, we expect a positive development of depression symptoms throughout the different time points (T1, T2, and T3) in patients with obesity. DISCUSSION: LightMood is an evidence-based, efficient, low-threshold online intervention that aims to reduce depression symptoms in people with obesity. Online interventions could offer a promising alternative to conventional face-to-face therapy. The primary objective of the current study is to add essential insight into the feasibility, efficacy, effectiveness, and acceptance of e-mental health interventions for people with obesity and depression symptoms. TRIAL REGISTRATION: German Clinical Trial Register (DRKS), DRKS00029219. Registered on May 19, 2023.

Drivers and barriers of patients' acceptance of video consultation in cancer care.

Background: Due to digitization in the medical sector, many healthcare interactions are switched to online services. This study assessed the acceptance of video consultations (VCs) in cancer care, and determined drivers and barriers of acceptance. Methods: A cross-sectional online-based survey study was conducted in Germany from February 2022 to February 2023. Recruitment took place at oncology outpatient clinics, general practitioners, oncology practices and via cancer-related social media channels. Inclusion criteria were a cancer diagnosis, cancer treatment and internet access. Sociodemographic, medical data, eHealth-related data were acquired via an online assessment. The Unified Theory of Acceptance and Use of Technology (UTAUT) model was used to determine the acceptance of VC and its predictors. Results: Of N = 350 cancer patients, 56.0% (n = 196) reported high acceptance of VC, 28.0% (n = 98) stated moderate acceptance and 16.0% (n = 56) indicated low acceptance. Factors influencing acceptance were younger age (ß = -.28, p < .001), female gender (ß = .35, p = .005), stage of disease (ß = .11, p = .032), high digital confidence (ß = .14, p = .010), low internet anxiety (ß = -.21, p = .001), high digital overload (ß = -.12, p = .022), high eHealth literacy (ß = .14, p = .028), personal trust (ß = -.25, p < .001), internet use (ß = .17, p = .002), and the UTAUT predictors: performance expectancy (ß = .24, p < .001), effort expectancy (ß = .26, p < .001), and social influence (ß = .34, p < .001). Conclusions: Patients' acceptance of VC in cancer care is high. Drivers and barriers to acceptance identified should be considered for personalized applications. Considering the growing demand for cancer care establishing digital healthcare solutions is justified.

Predictors of cancer patients' utilization of psychooncological support: Examining patient´s attitude and physician´s recommendation.

PURPOSE: Patients with cancer suffer from a wide range of psychological distress. Nevertheless, in the literature low utilization rates of psychooncological services are reported. Various factors may influence the utilization of professional support during inpatient care. Up to now it is unclear to what extent patients' attitude towards psychooncological support and physicians' recommendation for psychooncological care may influence the utilization. METHODS: In a multicenter longitudinal observational study in Comprehensive Cancer Centers Germany, 1398 patients with mixed cancer diagnoses were assessed at baseline during their hospital stay with respect to psychooncological distress and the need for and use of psychooncological services. RESULTS: Psychooncological support was used by almost 28.4% of patients up to this time. A positive attitude towards psychooncological support was reported by 41.6%. A recommendation of psychooncological support by a physician was received by 16.2%. These patients reported a significant higher level of distress compared to patients who did not received a recommendation. Multivariable logistic regression detected that the utilization rate was 3.79 times higher among patients with positive attitude towards psychooncological support (OR, 3.79; 95% CI 2.51-5.73, p < 0.001). Utilization was 4.21 times more likely among patients who received a physician´s recommendation (OR, 4.21; 95% CI 2.98-5.95, p < 0.001). CONCLUSION: The results of the study provide evidence of the relevance of giving more attention to psychooncological distress and attitudes towards psychooncological care. To reduce reservations, patients need low-threshold information about the psychooncological services offered.

Falling off the screening grid-Predictors for postponed utilization of psycho-oncological support in cancer patients and its implications for distress assessment and management.

OBJECTIVE: Distress assessment of cancer patients is considered state-of-the-art. In addition to distress scores, individual care needs are an important factor for the initiation of psycho-oncological interventions. In a mono-centric, observational study, we aimed for characterization of patients indicating a subjective need but declining to utilize support services immediately to facilitate implementation of adapted screenings. METHODS: This study analyzed retrospective data from routine distress screening and associated data from hospital records. Descriptive, variance and regression analyses were used to assess characteristics of postponed support utilization in patients with mixed cancer diagnoses in different treatment settings. RESULTS: Of the total sample (N = 1863), 13% indicated a subjective need but postponed support utilization. This subgroup presented as being as burdened by symptoms of depression (p < 0.001), anxiety (p < 0.001) and distress (p < 0.001) as subjectively distressed patients with intent to directly utilize support. Time periods since diagnosis were shorter (p = 0.007) and patients were more often inpatients (p = 0.045). CONCLUSIONS: Despite high heterogeneity among the subgroups, this study identified distress-related factors and time since diagnosis as possible predictors for postponed utilization of psycho-oncological interventions. Results suggest the necessity for time-individualized support which may improve utilization by distressed patients.

Caring for dependent children impacts practical and emotional problems and need for support, but not perceived distress among cancer patients.

OBJECTIVE: More than one in 10 cancer patients care for dependent children. It is unclear whether this status makes a difference in terms of the distress and associated problems they experience, or whether it is linked to differences in the need for or utilization of psychosocial support. METHODS: Secondary analysis of a cross-sectional German study in National Comprehensive Cancer Centers using self-report standardized questionnaires administered to inpatients. Patients living with dependent children (n = 161) were matched by age and sex with a subsample of 161 cancer patients not living with dependent children. The resulting sample was tested for between-group differences in Distress Thermometer (DT) scores and the corresponding DT Problem List. Additionally, between-group differences in measures of the need for and utilization of psychosocial support were examined. RESULTS: More than 50% of all patients suffered from clinically relevant distress. Patients living with dependent children reported significantly more practical (p < 0.001, η2 p = 0.04), family (p < 0.001, η2 p = 0.03), and emotional problems (p < 0.001, η2 p = 0.01). Although reporting a greater need for psychological support, parents with cancer were not found to more frequently utilize any type of psychosocial support. CONCLUSIONS: The specific problems and needs of parents with cancer who care for dependent children are currently not sufficiently addressed in the clinical care pathways. All families should be helped to establish open and honest communication as well as understand the available support systems and what they can provide. Tailored interventions should be implemented for highly distressed families.

Electronic Patient-Reported Outcome Measures (ePROMs) Improve the Assessment of Underrated Physical and Psychological Symptom Burden among Oncological Inpatients.

For advanced cancer inpatients, the established standard for gathering information about symptom burden involves a daily assessment by nursing staff using validated assessments. In contrast, a systematic assessment of patient-reported outcome measures (PROMs) is required, but it is not yet systematically implemented. We hypothesized that current practice results in underrating the severity of patients' symptom burden. To explore this hypothesis, we have established systematic electronic PROMs (ePROMs) using validated instruments at a major German Comprehensive Cancer Center. In this retrospective, non-interventional study, lasting from September 2021 to February 2022, we analyzed collected data from 230 inpatients. Symptom burden obtained by nursing staff was compared to the data acquired by ePROMs. Differences were detected by performing descriptive analyses, Chi-Square tests, Fisher's exact, Phi-correlation, Wilcoxon tests, and Cohen's r. Our analyses pointed out that pain and anxiety especially were significantly underrated by nursing staff. Nursing staff ranked these symptoms as non-existent, whereas patients stated at least mild symptom burden (pain: meanNRS/epaAC = 0 (no); meanePROM = 1 (mild); p < 0.05; r = 0.46; anxiety: meanepaAC = 0 (no); meanePROM = 1 (mild); p < 0.05; r = 0.48). In conclusion, supplementing routine symptom assessment used daily by nursing staff with the systematic, e-health-enabled acquisition of PROMs may improve the quality of supportive and palliative care.

Quality of Care Transition During Hospital Discharge, Patient Safety, and Weight Regain After Bariatric Surgery: a Cross-Sectional Study.

PURPOSE: Bariatric surgery is established as the gold standard in the treatment of severe obesity. However, a significant proportion of patients experience a substantial weight regain afterwards. Previous research focused predominantly on patients' personal factors. Yet, critical discharge process factors that contribute to patient's adherence after surgical interventions are rarely examined. This study investigated whether high quality of care transitions in discharge management influences weight regain and the likelihood of experiencing adverse patient safety incidents. MATERIALS AND METHODS: A cross-sectional study with 578 patients after bariatric surgery was conducted. Participants answered a standardized assessment on the quality of care transition from hospital to home-, surgery-, and nutrition-related characteristics as well as patient safety incidents. RESULTS: Significant weight regain was observed 24 months after surgery. The association between time since surgery and weight regain was weaker in patients with high quality of care transitions (B = 2.27, p < .001). Higher quality of care transition was also significantly related to a lower likelihood of unplanned hospital readmissions (OR = 0.67) and fewer medication complications (OR = 0.48) after surgery. CONCLUSION: This study sheds first light on the key influence of high quality of care transitions after bariatric surgery. Improvement efforts into effective discharge processes may establish smoother care transitions and help patients to assume responsibility and compliance with behavioral recommendations after surgery. Moreover, adverse patient safety incidents are less frequent after high quality care transitions indicating both high quality of health services for patients and reducing costs for the health care system.

Neurofeedback Treatment Affects Affective Symptoms, But Not Perceived Cognitive Impairment in Cancer Patients: Results of an Explorative Randomized Controlled Trial.

BACKGROUND: EEG biofeedback (NF) is an established therapy to enable individuals to influence their own cognitive-emotional state by addressing changes in brainwaves. Psycho-oncological approaches of NF in cancer patients are rare and effects are hardly studied. OBJECTIVE: The aim of this explorative, randomized controlled trial was to test the effectiveness of an alpha and theta NF training protocol, compared to mindfulness based therapy as an established psycho-oncological treatment. METHODS: Of initially 62 screened patients, 56 were included (inclusion criteria were cancer independent of tumor stage, age >18 years, German speaking; exclusion criteria suicidal ideation, brain tumor). Randomization and stratification (tumor stage) was conducted by a computer system. Participants got 10 sessions over 5 weeks, in (a) an NF intervention (n = 21; 13 female, 8 male; MAge = 52.95(10 519); range = 31 to 73 years)) or (b) a mindfulness group therapy as control condition (CG; n = 21; ie, 15 female, 6 male; MAge = 50.33(8708); range = 32 to 67 years)). Outcome parameters included self-reported cognitive impairment (PCI) as primary outcome, and secondary outcomes of emotional distress (DT, PHQ-8, GAD-7), fatigue (MFI-20), rumination (RSQ), quality of life (QoL, EORTC-30 QoL), self-efficacy (GSE), and changes in EEG alpha, and theta-beta band performance in the NF condition. RESULTS: No changes in cognitive impairment were found (P = .079), neither in NF nor CG. High affective distress was evident, with 70.7% showing elevated distress and 34.1% showing severe depressive symptoms. Affective symptoms of distress (P ≤ .01), depression (P ≤ .05) and generalized anxiety (P ≤ .05) decreased significantly over time. No differences between NF and CG were found. There was a significant increase of the alpha band (P ≤ .05; N = 15) over the NF sessions. Self-efficacy predicted QoL increase in NF with P ≤ .001 and an explained variance of 48.2%. CONCLUSION: This is the first study to investigate NF technique with regard to basic mechanisms of effectiveness in a sample of cancer patients, compared to an established psycho-oncological intervention in this field. Though there were no changes in cognitive impairment, present data show that NF improves affective symptoms comparably to mindfulness-based therapy and even more pronounced in QoL and self-efficacy.Trial registration: ID: DRKS00015773.

Cancer Patients' Age-Related Benefits from Mobile Neurofeedback-Therapy in Quality of Life and Self-efficacy: A Clinical Waitlist Control Study.

Electroencephalographic neurofeedback (EEG NF) can improve quality of life (QoL) and reduce distress by modifying the amplitude of selected brain frequencies. This study aims to investigate the effects of NF therapy on QoL and self-efficacy in cancer patients and to explore age-related reactions. In a waitlist control paradigm, psychometric data (EORTC QLQ-C30, General Self-Efficacy Scale) of 20 patients were collected at three different time points, each five weeks apart. An outpatient 10-session NF intervention (mobile) was conducted between the second and third measurement point. QoL and self-efficacy changed significantly over time (QoL: F(2,36) = 5.294, p < .05, η2 = .227; Self-efficacy: F(2,26) = 8.178, p < .05, η2 = .386). While QoL increased in younger patients, older patients initially showed a decrease in QoL, which then increased during intervention. Younger patients did not differ from older patients in QoL in both waitlist control (T0-T1) and intervention phase (T1-T2). QoL in older patients significantly differed between waitlist control and intervention phase (Z = - 2.023, p < .05, d = 1.085). Self-efficacy increased in both age categories. Younger and older patients did not differ in self-efficacy in waitlist control, but in intervention phase (F(1,16) = 7.014, p < .05, η2 = .319). The current findings suggest that NF therapy is a promising treatment modality for improving QoL in cancer patients. Our study reveals NF being a tool to influence self-efficacy, which should receive more appreciation in clinical care. However, the effect of NF in different age groups as well as the influence on further cancer-related symptoms should be investigated in future research.

Mindfulness and skills-based eHealth intervention to reduce distress in cancer-affected patients in the Reduct trial: Intervention protocol of the make it training optimized.

Introduction: Cancer-affected patients experience high distress due to various burdens. One way to expand psycho-oncological support is through digital interventions. This protocol describes the development and structure of a web-based psycho-oncological intervention, the Make It Training optimized. This intervention is currently evaluated in the Reduct trial, a multicenter randomized controlled trial. Methods: The Make It Training optimized was developed in six steps: A patient need and demand assessment, development and acceptability analysis of a prototype, the formation of a patient advisory council, the revision of the training, implementation into a web app, and the development of a motivation and evaluation plan. Results: Through a process of establishing cancer-affected patients' needs, prototype testing, and patient involvement, the Make It Training optimized was developed by a multidisciplinary team and implemented in a web app. It consists of 16 interactive self-guided modules which can be completed within 16 weeks. Discussion: Intervention protocols can increase transparency and increase the likelihood of developing effective web-based interventions. This protocol describes the process and results of developing a patient-oriented intervention. Future research should focus on the further personalization of web-based psycho-oncological interventions and the potential benefits of combining multiple psychotherapeutic approaches.

Development and Validation of Dietary Behavior Inventory-Surgery (DBI-S) in the Scope of International Post-Bariatric Surgery Guidelines and Recommendations.

(1) Dietary behavior is highly relevant for patients after bariatric surgery. No instrument exists assessing adherence to medical guidelines concerning the dietary behavior of patients after bariatric surgery. The aim of this study was to develop and validate such an instrument. (2) Data from patients after bariatric surgery (n = 543) were collected from March to May 2022. The development of the DBI-S was theory-based and interdisciplinary. Items' and content validity of the DBI-S were examined. (3) The final version of the DBI-S consists of 13 items. Convergent validation was confirmed by significant correlations between DBI-S score and attitude towards healthy food (r = 0.26, p = <0.001) and impulsivity (r = −0.26, p = <0.001). Criterion validity was confirmed by significant correlations between DBI-S score and pre-/post-surgery BMI difference (r = −0.14, p = 0.002), pre-/post-surgery weight difference (r = 0.13, p = 0.003), and quality of life (r = 0.19, p = <0.001). Cluster analysis confirmed the ability to distinguish between two dietary behavior clusters (rather healthy and rather unhealthy). (4) The DBI-S is an economic and valid instrument to assess the adherence of post-bariatric surgery patients to the relevant dietary behavior recommendations and guidelines and can distinguish between rather unhealthy and healthy dietary behavior.

Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct.

INTRODUCTION: Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint). METHODS AND ANALYSIS: The study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18-65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate. ETHICS AND DISSEMINATION: The Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations. TRIAL REGISTRATION NUMBER: German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.

[Burden of Affected Persons with MRKH Syndrome: Effect of an Intervention to Support Surgical Neovaginal Placement]. / Belastung von Betroffenen mit MRKH-Syndrom: Effekt einer Intervention zur Unterstützung bei Neovagina-Anlage.

The diagnosis of Mayer-Rokitansky-Küster-Hauser syndrome (MRKHS), a rare variant of female sexual development, is usually made during puberty. The uncertainty in self-image and the impos-sibility of becoming pregnant often lead to considerable stress. Although psychosomatic support is consistently recommended in the literature, there have been only a few studies on the psychological aspects of MRKHS. The aim of the present study is to investigate the quality of life or distress of women with MRKHS undergoing neovaginal surgery and, on the other hand, to evaluate effects of the intervention for support during treatment. Methods In an explorative quasi-experimental pre-post study at a national centre for neovaginal surgery, all patients were offered a psychosomatic intervention (intervention group IG, n=23) and their sexual function (FSFI), psychological distress (PHQ-D) and health-related quality of life (SF-12) were assessed before surgery (t0) and six months after (t1). These were compared with data from a sample collected before and after the intervention period (comparison group VG, n=30). Results While the physical quality of life (SF-12) of both groups was unremarkable at both time points, there was a significant impairment in the psychological quality of life. Both groups (IG, VG) improved from t0 to t1 in their sexual function (FSFI) and showed lower depression scores (PHQ-D). The specific intervention developed was well accepted by those affected and rated as helpful. However, this subjectively perceived effectiveness of the intervention was not reflected by improvement on the quality of life scale (SF-12) and depression scale (PHQ-D). Conclusion Those affected show a clear, clinically relevant distress (SF-12), but this is not reflected in the form of psychological comorbidity (PHQ-D). This apparent discrepancy points to psychologically stable women with acute distress due to the diagnosis of variant sex de-evolution. For them, a low-threshold support service with a supportive character seems to be necessary and helpful during the surgical treatment. The reconstructive therapy for the creation of a neovagina seems to have a positive influence on the psychological quality of life. The fact that pregnancy is still not possible due to the missing uterus could be a reason for not reaching the quality of life of the average population.

Increased Safety Behavior and COVID-19-Related Fear in Adults with Cystic Fibrosis during the Pandemic.

People with cystic fibrosis (pwCF) face great challenges during the ongoing COVID-19 pandemic. Recent research found equal levels of distress in pwCF and healthy controls (HC). The current study aimed to investigate the mental health burden and safety behavior in pwCF. Sixty-nine adult pwCF and sixty-nine propensity-score-matched HC participated in this study. Participants completed an anonymous online questionnaire assessing distress, generalized anxiety, depressive symptoms, COVID-19-related variables, self-reported adherent safety behavior (ASB), and dysfunctional safety behavior (DSB). PwCF showed equal amounts of distress (W = 2481.0, p = 0.669), depressive symptoms (W = 2632.5, p = 0.268), and generalized anxiety symptoms (W = 2515.5, p = 0.565) compared to the HC. COVID-19-related fear (W = 1872.0, p = 0.028), ASB (W = 1630.0, p = 0.001), and DSB (W = 1498.5, p < 0.001) were significantly elevated in pwCF. The pwCF estimated that the probability of suffering from symptoms (W = 954.5, p < 0.001), experiencing a severe course (W = 806.5, p < 0.001), or dying (W = 1079.0, p < 0.001) from COVID-19 is significantly higher than that of the HC. ASB was associated with a CF diagnosis, COVID-19-related fear, and a subjective level of information (R2 = 0.414, F(13, 124) = 6.936, p ≤ 0.001). DSB was associated with a diagnosis of CF and COVID-19-related fear (R2 = 0.196, F(13, 124) = 3.169, p ≤ 0.001). The data suggest that pwCF show functional and adequate behaviors towards the risk caused by the pandemic. Therefore, functional coping behaviors may provide advantages in addressing pandemic challenges.