Implementation Readiness and Initial Effects of a Brief Mindfulness Audio Intervention Compared With a Brief Music Control During Daily Radiation Therapy for Prostate Cancer: A Randomized Pilot Study.

Background: The most common and debilitating side effects of radiation therapy (RT) for prostate cancer (PC) are fatigue, sleep disturbance, anxiety, and depression. Previous research has reported palliative benefits from certain self-management approaches, such as mindfulness meditation. Objective: To develop, pre-test, and evaluate the feasibility, acceptability and initial benefit of brief, audio-based mindfulness delivered during daily RT for PC compared to a relaxing music control. Methods: Following intervention development, participants were randomized to either brief guided mindfulness audio recordings or a relaxing music control during daily RT. A pre-testing phase was first conducted to determine optimal program start time, length, and content most associated with retention. A final program (n = 26) was delivered daily, starting on day one of week 2 of RT and lasting 4 consecutive weeks. Feasibility was defined as ≥70% on enrollment rate, retention, and audio program adherence. Acceptability was measured with a 12-item post-study survey. A secondary focus compared between group changes on patient reported outcomes of fatigue, anxiety, depression, sleep disturbance, and related outcomes at baseline and follow up assessments. Descriptive statistics and general linear models were used. Results: Overall, 76% (n = 38) of approached men enrolled. Pre-testing retention rates were <70% while the final program's retention rate was 89%. The majority of acceptability criteria were met in both conditions, with relatively higher ratings in the mindfulness arm. Compared to music controls, mindfulness participants demonstrated significantly less uncertainty intolerance at 4-weeks (P = .046, d = .95); and significantly lower fatigue scores (P = .049, d = 1.3) and lower sleep disturbance scores (P = .035, d = 1.1) at the 3 months follow up. Conclusion: The final intervention met feasibility and acceptability criteria. Pre-testing refinements played a key role for optimal program delivery and retention. Audio-based mindfulness delivered during RT for PC hold potential to help decrease RT-related physical and emotional side effects.

Development and Implementation of a Culturally Informed Spanish Language Yoga Program for Latiné Women With Overweight or Obesity Diagnosed With Cancer: A Single Arm Pilot Study.

Background: Given limited yoga research in health disparities populations, we developed and evaluated a 12-week Spanish language yoga program for Latiné women with overweight or obesity affected by cancer. The program aimed to empower participants through culturally tailored yoga practice and opportunities for social connection and support. Methods: Partnering with a community-based organization, the program was co-created by bilingual (English and Spanish-speaking) yoga instructors, Latiné cancer survivor support professionals, and integrative medicine researchers. The single arm intervention consisted of 12 separate, 60-minute Hatha yoga classes, including physical postures, breathing exercises, culturally relevant poetry, and post-practice socialization opportunities. Measures were administered at baseline, 12-week, and 24-week. Results: Thirty-five eligible participants enrolled in the program, demonstrating high feasibility and relevance as well as high levels of engagement in home practice. Some participants faced barriers to regular home practice, including family responsibilities and concerns about proper pose execution. Preliminary outcome analyses indicated improvements in sleep disturbance, pain interference, depression, and blood pressure post-intervention, with sustained improvements in depression, anxiety, and blood pressure at 24-week. No significant changes were observed in fatigue, physical function, positive affect, satisfaction with social roles and activities, and weight. Structured post-practice social snack time with yoga instructors (compared with unstructured time with peers) was associated with self-reported improvements in satisfaction with social roles and activities and weight loss. Conclusion: This yoga program successfully engaged female Latiné cancer survivors with overweight and obesity and serves as a foundational step in empowering this population to improve their health and well-being through culturally tailored yoga practice. Future research should utilize controlled study designs and engage participants from different geographical regions to study the efficacy and sustainability of findings.

Electronic health intervention to manage symptoms of immunotherapy in patients with cancer (SOFIA): Results from a randomized controlled pilot trial.

BACKGROUND: For patients receiving immune checkpoint inhibitors, early detection of immune-related adverse events (irAEs) is critical for one's safety. To this end, a smartphone app (SOFIA) was developed that featured the assessment of electronic patient-reported outcomes (ePROs) focusing on irAEs as well as a set of comprehensive supportive information. Its feasibility and preliminary efficacy were evaluated in a randomized controlled trial (RCT). METHODS: Patients who received immune checkpoint inhibition therapy were randomly assigned to an intervention group (IG) or a control group (CG; care as usual). During the 12-week intervention period, IG patients used SOFIA to report twice weekly ePROs and receive cancer- and immunotherapy-relevant contents. Before a patient's next clinical visit, the physician in charge was given the ePRO reports. The primary objective was to test the feasibility of SOFIA. Furthermore, the preliminary efficacy of SOFIA for health-related quality of life (HRQOL), psychosocial outcomes, and medical data was examined. Clinical outcomes were assessed at baseline (T0), post-intervention (T1), and a 3-month follow-up (T2). RESULTS: Seventy-one patients were randomized to the IG (n = 34) or the CG (n = 37). SOFIA showed high feasibility and acceptance. At T1, patients in the IG reported significantly better HRQOL and role functioning and less depression, distress, and appetite loss. No significant differences were revealed regarding medical data, the utilization of supportive care services, or survival. CONCLUSIONS: SOFIA showed high feasibility and acceptance and improved HRQOL and psychosocial outcomes. These results suggest further evaluation of efficacy in a large-scale confirmatory multicenter RCT.

Health-related quality of life and fear of progression in individuals with Li-Fraumeni syndrome.

Li-Fraumeni syndrome (LFS) is a rare autosomal dominant cancer predisposition syndrome associated with a highly elevated lifetime cancer risk. This and the recommended intense surveillance program represent a large psychological burden on families. In order to develop targeted psychosocial interventions, we conducted a needs assessment. Adults (≥18 years) with LFS were included via regular hospital visits and online support groups and newsletters. Individuals filled out a questionnaire addressing among others: fear of progression (FoP-questionnaire, short-form), health-related quality of life (HRQoL, Short-Form Health Survey-12), distress (National Comprehensive Cancer Network distress thermometer), perceived cancer risk, and aspects of surveillance adherence. Collecting data over a 14-month period (March 2020 - June 2021), 70 adults were recruited (female = 58, 82.9%; mean age = 41.53 years). With mean mental component scores (MCS) of 42.28 (SD = 10.79), and physical component scores (PCS) of 48.83 (SD = 10.46), HRQoL was low in 34.8% (physical) and 59.4% (mental) of individuals when applying a mean cut-off of 45.4 (PCS) and 47.5 (MCS) to indicate poor HRQoL. High levels of FoP and distress were present in 68.6% and 69.1% of the participants, respectively. Performing a multiple linear regression on MCS and PCS, no sociodemographic variable was shown to be significant. FoP (ß = -0.33, p < 0.05) and distress (ß = -0.34, p < 0.05) were significantly associated with MCS. Individuals in our sample were burdened more than expected, with the majority reporting low levels of (mental) HRQoL, high distress, and FoP. Psychosocial support is necessary to help individuals with LFS (survivors as well as "previvors") increase their HRQoL, as it is crucial to survival.

Exploring Breast Surgeons' Attitudes on Universal Genetic Testing: A Qualitative Study.

BACKGROUND: The American Society of Breast Surgeons released a consensus statement that genetic testing should be made available to all patients with a personal history of breast cancer. However, it is not clear whether physicians feel comfortable with universal genetic testing (UGT) or if they have sufficient knowledge to interpret results and manage them appropriately. OBJECTIVE: The purpose of this study was to explore breast surgeons' attitudes toward UGT. METHODS: Breast surgeons were consented and scheduled for a semi-structured virtual interview. Transcripts were uploaded into qualitative analysis software where they were exhaustively and iteratively coded. Codes were then organized into higher-order categories and themes and data saturation were assessed. RESULTS: Thirty-one surgeons completed the qualitative interview. Most surgeons practiced in the academic or community setting and most practiced in the Midwest (71.0%). The majority (90.3%) reported having a structured genetics program. The majority (96.8%) referred their patients to genetics for counseling and most preferred ordering testing through a genetic services provider. Some surgeons had concerns about access to genetic services. A minority of surgeons order UGT for all newly diagnosed breast cancer patients. The majority of respondents thought that more training in genetics was needed for surgeons. Many surgeons expressed concern about the psychosocial effects of UGT on patients. CONCLUSIONS: Many surgeons expressed concerns about UGT, mainly related to discomfort with their training, access to genetic services, and the psychosocial impact on their patients. Future work is needed to determine how to improve surgeon's comfort level in implementing UGT.

Mindfulness-based stress reduction for men on active surveillance for prostate cancer and their spouses: Design and methodology of a randomized controlled trial.

BACKGROUND: Although active surveillance (AS) is an increasingly adopted treatment paradigm for management of very low risk prostate cancer, many men and their partners face a variety of AS-related psychosocial stressors. Stressors may include anxiety and fear of progression, which may negatively affect short- and long-term psychosocial adjustment and influence early withdrawal from AS in order to seek definitive therapies such as surgery or radiation. Here we describe the protocol for an NCI-funded trial, which seeks to examine the efficacy of mindfulness training compared with a time/attention-matched health promotion control condition in a geographically generalizable sample of men on AS and their spouses. METHODS: Using a randomized, controlled, partially double-blinded study design, this study involves the delivery of 8 weeks of standardized mindfulness training (MBSR; mindfulness-based stress reduction) and patient reported outcomes over a 12-month period (proposed enrollment of 80 men on AS and spouses), compared with a health promotion control (proposed enrollment of 80 men on AS and spouses) that has been matched for time and attention. Baseline (T1) measures (e.g., anxiety, fear of progression, quality of life) are administered just prior to randomization to the two study arms, followed by repeated assessments at 2 months (T2), 6 months (T3) and 12 months (T4). CONCLUSION: This study has the potential to offer men and their partners on AS with important educational and self-regulatory skills to better cope and adjust with known stressors related to being placed on this protocol.

Adult alcohol drinking and emotional tone are mediated by neutral sphingomyelinase during development in males.

Alcohol use, abuse, and addiction, and resulting health hazards are highly sex-dependent with unknown mechanisms. Previously, strong links between the SMPD3 gene and its coded protein neutral sphingomyelinase 2 (NSM) and alcohol abuse, emotional behavior, and bone defects were discovered and multiple mechanisms were identified for females. Here we report strong sex-dimorphisms for central, but not for peripheral mechanisms of NSM action in mouse models. Reduced NSM activity resulted in enhanced alcohol consumption in males, but delayed conditioned rewarding effects. It enhanced the acute dopamine response to alcohol, but decreased monoaminergic systems adaptations to chronic alcohol. Reduced NSM activity increased depression- and anxiety-like behavior, but was not involved in alcohol use for the self-management of the emotional state. Constitutively reduced NSM activity impaired structural development in the brain and enhanced lipidomic sensitivity to chronic alcohol. While the central effects were mostly opposite to NSM function in females, similar roles in bone-mediated osteocalcin release and its effects on alcohol drinking and emotional behavior were observed. These findings support the view that the NSM and multiple downstream mechanism may be a source of the sex-differences in alcohol use and emotional behavior.

Prenatal paternal depression, anxiety, and somatic symptom burden in different risk samples: an explorative study.

PURPOSE: Growing evidence implies that transition to parenthood triggers symptoms of mental burden not only in women but likewise in men, especially in high-risk pregnancies. This is the first study that examined and compared the prevalence rates of depression, anxiety, and somatic symptom burden of expectant fathers who face different risk situations during pregnancy. METHODS: Prevalence rates of paternal depression (Edinburgh postnatal depression scale), anxiety (generalized anxiety disorder seven), and somatic symptom burden (somatic symptom scale eight) were examined in two risk samples and one control group in the third trimester of their partners' pregnancy: risk sample I (n = 41) consist of expectant fathers whose partners were prenatally hospitalized due to medical complications; risk sample II (n = 52) are fathers whose partners were prenatally mentally distressed; and control group (n = 70) are those non-risk pregnancies. RESULTS: On a purely descriptive level, the data display a trend of higher symptom burden of depression, anxiety, and somatic symptoms in the two risk samples, indicating that expectant fathers, whose pregnant partners were hospitalized or suffered prenatal depression, were more prenatally distressed. Exploratory testing of group differences revealed an almost three times higher prevalence rate of anxiety in fathers whose partner was hospitalized (12.2%) compared to those non-risks (4.3%). CONCLUSION: Results underline the need for screening implementations for paternal prenatal psychological distress, as well as specific prevention and treatment programs, especially for fathers in risk situations, such as their pregnant partners' prenatal hospitalization. The study was registered with the German clinical trials register (DRKS00020131) on 2019/12/09.

Suicidal ideation in patients with cancer: Its prevalence and results of structural equation modelling.

OBJECTIVE: Patients with cancer have a higher risk of suicidal ideation (SI) and suicidality than the general population. This study was designed to investigate the prevalence of SI and its association with psychosocial and sociodemographic factors and tumour entity. METHODS: In this observational cross-sectional study, 4372 adult patients with different cancer entities were enrolled. We assessed the outcome variables (i.e. SI, depressive and anxiety symptoms, mental and physical fatigue and sociodemographic data) using self-report questionnaires. Data were analysed via descriptive statistics, binomial logistic regression and structural equation modelling (SEM). RESULTS: Among all patients, 627 (14.3%) reported SI, of whom 12.8% reported SI on several days, 0.9% on half of the days and 0.6% nearly every day. Age, anxiety, mental fatigue and the Patient Health Questionnaire-9 items 'feeling down, depressed and hopeless', 'feeling bad about oneself' and 'slowing or agitation' were significant predictors of SI. SEM, including all significant predictors with a latent depressiveness-demoralisation variable, explained 30.3% variance of SI, showing a good fit. CONCLUSIONS: Our results showed that a significant number of patients with cancer show SI. Future long-term studies are needed to address the differential contribution of depression and demoralisation on SI in patients with cancer.

Health-related quality of life of advanced prostate cancer patients and spouses: results from actor-partner interdependence models.

BACKGROUND: Patients with prostate cancer (PC) and their spouses are confronted with several treatment-related and psychosocial challenges that can reduce their health-related quality of life (HRQoL). Patients with advanced PC (aPC) and their spouses are at highest risk for psychological distress and show lower HRQoL compared with couples in other phases. The aim of this study was to investigate the psychological interdependencies between HRQoL and anxiety, fear of progression (FoP), and depression in patients with aPC and their spouses. METHODS: Ninety-six heterosexual couples with aPC participated in this cross-sectional study. Patients and spouses provided information about anxiety and depression (Patient Health Questionnaire-4), fear of progression (short form of the Fear of Progression Questionnaire), and HRQoL (EORTC QoL-C30, version 3). Psychological interdependencies were analyzed with various actor-partner interdependence models using structural equation modeling. RESULTS: Anxiety, FoP, and depression were significant predictors of HRQoL for patients with aPC and their spouses (actor effects). Spouses' anxiety and FoP were negatively associated with patients' HRQoL (partner effects), showing that patients' HRQoL is associated with their own and their spouses' anxiety and FoP. No partner effect was revealed between depression and HRQoL in the patients or spouses. CONCLUSIONS: The resulted partner effects between spouses and patients underline the importance of considering HRQoL in patients with aPC from a dyadic perspective. It is important that physicians explore patients' and spouses' needs and psychological burden to offer support and access to psycho-oncological services. Future studies are needed to investigate the effects of suitable interventions on spouses' anxiety and FoP.

Couples coping with advanced prostate cancer: An explorative study on treatment decision making, mental deterioration, partnership, and psychological burden.

OBJECTIVES: The aim of this study was to evaluate the role of spouses and the relevance of quality of life (QoL) and life expectancy (LE) in the treatment decision-making process of patients with advanced prostate cancer (CaP). We also addressed the role of possible mental deterioration, partnership quality, QoL, distress, anxiety, and depression in patients and their spouses. METHODS AND MATERIAL: This was a cross-sectional non-interventional explorative study. We administered questionnaires to 96 patients with advanced CaPand their spouses. Both patients and their spouses were asked about the influence of the spouses on treatment decision making, if they prefer quality of life or life expectancy as main goal of treatment and the perceived deterioration of the patients' mental abilities. Additional questionnaires were used to assess medical history, partnership, global quality of life, distress, depression, and anxiety. We performed statistical tests to compare patients with spouses and correlations to detect associations between variables. RESULTS: The spouses (65 ± 9 years) were significantly younger than the patients (69 ± 9 years). Ninety-five percent of the patients and 91% of the spouses reported that the spouses were involved in making treatment decisions. There was a high similarity within couples with regard to their preference for QoL or LE during treatment. Between couples, this preference differed markedly. Emotional control and motivation were the areas most commonly reported to have deteriorated among patients' mental abilities. The quality of the partnership was rated as being higher than average by both partners. Among the spouses, the quality of partnership correlated significantly with the preference for LE with regard to treatment decision making. Patients and spouses reported high psychological burdens in all areas, with higher levels of distress and anxiety in spouses (P< 0.01). Reduced quality of life and greater distress, depression, and anxiety were significantly correlated with the amount of deterioration of the patients' mental abilities. CONCLUSIONS: Spouses of patients with advanced CaP seem to respond to different aspects of the disease by adjusting both their involvement in treatment decision making and their preferred goal of treatment. Due to mental deterioration in the patients and pronounced anxiety in their spouses, we suggest that it is important for the attending physician to provide detailed information and support to both partners. Overall, the high-stress situation seems to affect both partners to similar degrees.

The Development of iManage-PC, an Online Symptom Monitoring and Self-management Tool for Men With Clinically Localized Prostate Cancer.

BACKGROUND: Prostate cancer (PC) often impacts 4 major aspects of health-related quality of life (HRQL): urinary, sexual, and bowel dysfunction, and anxiety. Online tools may be helpful in supporting the development of self-management skills that can improve HRQL. OBJECTIVE: The aim of this study was to develop and pilot-test an online symptom monitoring and self-management program, iManage-PC. METHODS: A literature search, input from experts, and feedback from patients were used to develop iManage-PC. A 4-week, single-arm pilot study was conducted with 96 men with prostate cancer. We evaluated system usability, acceptance, and satisfaction and examined preliminary effects on patient-reported outcomes. RESULTS: Rates of retention (94.8%) and adherence to symptom monitoring (95.0%-97.0%) were high. Most participants rated the tool as satisfactory and acceptable (81.2%-94.3%). Related-samples Wilcoxon signed rank tests revealed that participants reported increased self-efficacy related to their ability to manage their adverse effects (T = 1772.0, P < .001, r = 0.39), physical discomfort (T = 1259.0, P < .001, r = 0.40), and stress and worry (T = 1108.5, P = .001, r = 0.34). Global mental and physical health also improved (T = 1322.0, P = .032, r = 0.23, and T = 1409.0, P = .001, r = 0.35, respectively). CONCLUSIONS: Future research with such tools should examine the potential role of cut-score-derived management interventions to improve engagement, symptom management self-efficacy, and HRQL. IMPLICATIONS FOR PRACTICE: Our findings are consistent with a growing body of literature that supports the feasibility and acceptability of remotely delivered interventions.

Psychosocial and Biological Outcomes of Immersive, Mindfulness-Based Treks in Nature for Groups of Young Adults and Caregivers Affected by Cancer: Results from a Single Arm Program Evaluation from 2016-2021.

The COVID-19 pandemic has left many individuals suffering from "connection deficit disorder" given changes to the way we work, go to school, socialize, and engage in daily activities. Young adults affected by cancer between the ages of 18-39 have known this connection deficit long before the pandemic. Being diagnosed and treated for cancer during this time can significantly disrupt engagement in important educational, career, social, and reproductive pursuits, and contribute to increased stress, anxiety, depression, and other negative outcomes. Experiencing meaningful connection-with nature, with peers who understand, and with oneself, may help assuage this adverse effect of disconnect. A single arm within-subjects program evaluation was conducted to examine outcomes following participation in immersive, multi-night, mindfulness-based treks in nature in a sample of young adults (n = 157) and caregivers (n = 50) affected by cancer from 2016-2021. Pre to post-trek changes included significant (p < 0.001) self-reported improvements in feeling connected to nature (d = 0.93-0.95), peers (d = 1.1-1.3), and oneself (d = 0.57-1.5); significant (p < 0.001) improvements on PROMIS Anxiety (d = 0.62-0.78), Depression (d = 0.87-0.89), and Sleep Disturbance (d = 0.37-0.48) short forms; and significant (p < 0.05) changes in pro-inflammatory biomarkers (d = 0.55-0.82). Connection-promoting experiences like this have the potential to improve health and wellbeing in this population and serve as a model for others.

Neutral sphingomyelinase mediates the co-morbidity trias of alcohol abuse, major depression and bone defects.

Mental disorders are highly comorbid and occur together with physical diseases, which are often considered to arise from separate pathogenic pathways. We observed in alcohol-dependent patients increased serum activity of neutral sphingomyelinase. A genetic association analysis in 456,693 volunteers found associations of haplotypes of SMPD3 coding for NSM-2 (NSM) with alcohol consumption, but also with affective state, and bone mineralisation. Functional analysis in mice showed that NSM controls alcohol consumption, affective behaviour, and their interaction by regulating hippocampal volume, cortical connectivity, and monoaminergic responses. Furthermore, NSM controlled bone-brain communication by enhancing osteocalcin signalling, which can independently supress alcohol consumption and reduce depressive behaviour. Altogether, we identified a single gene source for multiple pathways originating in the brain and bone, which interlink disorders of a mental-physical co-morbidity trias of alcohol abuse-depression/anxiety-bone disorder. Targeting NSM and osteocalcin signalling may, thus, provide a new systems approach in the treatment of a mental-physical co-morbidity trias.

eHealth intervention to manage symptoms for patients with cancer on immunotherapy (SOFIA): a study protocol for a randomised controlled external pilot trial.

INTRODUCTION: Immune checkpoint therapy (ICT) is associated with a distinct pattern of immune-related adverse events (irAEs) caused by inadvertently redirecting immune responses to healthy tissues. IrAEs can occur at any time; however, in most cases, they arise during the first 14 weeks of the beginning of immune checkpoint blockade. In many cases, immunotherapy must be discontinued due to irAEs. Early detection of irAEs triggers the temporary withholding of ICT or initiation of short-term immunosuppressive treatment, is crucial in preventing further aggravation of irAEs and enables safe re-exposure to ICT. This prospective study aims to evaluate the feasibility of an eHealth intervention for patients under immunotherapy (managing symptoms of immunotherapy, SOFIA). The SOFIA-App consists of two components: SOFIA-Monitoring, a tool to rate patient-reported outcomes (PROs) including irAEs, and SOFIA-Coaching, which provides important information about cancer-specific and immunotherapy-specific topics and the counselling services of the National Centre for Tumour Diseases (NCT) Heidelberg. METHODS AND ANALYSIS: We outlined a patient-level two-arm randomised controlled pilot trial of the intervention (SOFIA) versus no-SOFIA for patients with cancer beginning an immunotherapy, aged ≥18 years, recruited from the NCT, Heidelberg. Feasibility outcomes include: recruitment rate; drop-out rate; reasons for refusal and drop-out; willingness to be randomised, utilisation rate of SOFIA-Monitoring and utilisation time of SOFIA-Coaching, physicians utilisation rate of the PROs; feasibility of the proposed outcome measures and optimal sample size estimation. The clinical outcomes are measures of quality of life, psychosocial symptoms, self-efficacy, physician-patient communication and medical process data, which are assessed at the beginning of the intervention, postintervention and at 6-month follow-up. ETHICS AND DISSEMINATION: This trial protocol was approved by the Ethical Committee of Heidelberg University, Germany (Reference, S-581/2018). TRIAL REGISTRATION NUMBER: We registered the study in the German Clinical Trial Register (Reference: DRKS00021064). Findings will be disseminated broadly via peer-reviewed empirical journals, articles and conference presentations.

Development and Implementation of a Brief Healthcare Professional Support Program Based in Gratitude, Mindfulness, Self-compassion, and Empathy.

OBJECTIVE: To highlight the development, implementation, and initial findings of a brief healthcare professional support program called "GRACE." BACKGROUND: Healthcare professionals face significant work-related stressors that when left unmanaged can negatively affect their overall well-being and contribute to burnout. METHODS: Over a 2-year period, the GRACE program was delivered to 8 clinical units at a midsized southwestern hospital. Questionnaires were administered at baseline and 1 month. RESULTS: Program participants were 36 years old on average, female (81%), and White (68%) and mostly employed as nurses (66%). Attendees reported increased knowledge, understanding, and confidence and found the program to be acceptable. One month after training, participants demonstrated significant improvements in self-compassion. Medical units that received GRACE training saw significantly greater increases in patient satisfaction scores compared with units that did not receive training. CONCLUSIONS: The GRACE program was feasible and acceptable to deliver, and initial proof-of-concept evidence was supported.

Screening and Psycho-Oncological Support for Patients With Head and Neck Cancer and Brain Malignancies Before Radiotherapy With Mask Fixation: Results of a Feasibility Study.

This single-center, single-arm trial investigates the feasibility of a psycho-oncological care program, which aims to reduce psychological distress and improve compliance with radiotherapy with mask fixation in patients with head and neck cancer or brain malignancies. The care program comprised (1) a screening/needs assessment and (2) the provision of a psycho-oncological intervention using imaginative stabilization techniques for distressed patients (distress due to anxiety ≥5) or in a case of subjective interest in the psycho-oncological intervention. Another allocation path to the intervention was directly through the radiation oncologist in charge who classified the patient as: in need of support to tolerate the immobilization device. Of a total of 1,020 screened patients, 257 (25.2%) patients indicated a distress ≥5 and 141 (13.8%) patients reported panic attacks. 25% of the patients reported a subjective interest in psycho-oncological support. A total of 35 patients received the psycho-oncological intervention, of which 74% were assigned by radiation oncologists. In this small patient cohort, no significant pre-post effects in terms of depression, anxiety, distress, and quality of life (mental and physical component scores) could be detected. Our results indicate a good feasibility (interdisciplinary workflow and cooperation, allocation by physicians in charge) of the psycho-oncological care program for this cohort of patients before radiotherapy with mask fixation. The screening results underline the high psychological distress and demand for psycho-oncological support. However, since the utilization of our intervention was low, future studies should reduce the barriers and improve compliance to psycho-oncological services by these patients.Clinical Trial Registration: https://www.drks.de/drks_web/setLocale_EN.do #DRKS00013493.

[Development and Evaluation of an Acceptance and Commitment Therapy (ACT)-Based Group Intervention for Cancer Patients with Psychological Burden]. / Entwicklung und Evaluation einer Akzeptanz- und Commitment-Therapie (ACT)-basierten Gruppenintervention für psychisch belastete onkologische Patienten.

OBJECTIVE: Cancer is associated with many psychosocial stressors that lead to high psychological distress in over 50% of patients. About one third of patients make use of psycho-oncological services. Acceptance and Commitment Therapy (ACT), a transdiagnostic approach of the third wave of cognitive behavioral therapy, represents a promising approach for psycho-oncological interventions. However, the German-speaking area lacks a manualized ACT-based group intervention that is tested for feasibility and effectiveness. METHODS: To bridge this gap, we developed and preliminarily tested an ACT group intervention in this one-arm monocentric pilot study. It targets psychological burdened cancer patients in all disease stages. During 8 sessions, the ACT core processes mindfulness, values and acceptance are worked out by means of metaphors and experience-oriented exercises. RESULTS: Pre-Post-Data of our pilot study with n=25 patients indicate reductions in fear of progression, depression and psychological inflexibility, as well as an increase in psychological health-related quality of life and well-being. Regression analyses showed that changes in psychological flexibility predicted changes in all psychological outcome measures. The very high adherence underlines the feasibility of the intervention for the integrated outpatient clinic setting. DISCUSSION: Our pilot study provides first evidences for the good feasibility and effectiveness of an ACT-based group intervention in the German-speaking area. These results on effectivness should be interpreted with caution due to the lack of an experimental control group. CONCLUSION: Future studies should test the effectiveness of the intervention in randomized controlled trials (RCTs) with longer follow-up periods.

Impact of social support on psychosocial symptoms and quality of life in cancer patients: results of a multilevel model approach from a longitudinal multicenter study.

Background: This prospective multicenter study aimed to investigate the courses of positive support (PS) and detrimental interaction (DI), two different aspects of social support, and the relation between social support and psychosocial distress and/or health-related quality of life (HRQOL) in a large sample of patients with different cancers. Methods: For this observational study, we enrolled adult patients with cancer from 13 comprehensive cancer centers (CCCs) in Germany. We included a total of 1087 patients in our analysis. We assessed the outcomes via standardized self-report questionnaires at three measurement points: at admission for acute care (T1), 6 (T2) and 12 months (T3) thereafter. Our outcome variables included PS and DI, depression and anxiety symptoms, distress, mental quality of life (MQoL) and physical QoL (PQoL). Data were analyzed using three-level hierarchical linear modeling (HLM) and group-based trajectory modeling. Results: During the first year after the cancer diagnosis, both PS and DI decreased in our sample. Baseline depression symptom severity was a significant predictor of PS and DI. Further analyses revealed significant associations between PS, DI and the course of depression and anxiety symptoms, and MQoL. PS buffered the negative effects of DI with regards to these variables. Low DI was associated with better PQoL, whereas PS was not. In general, the impact of social support on psychosocial outcomes was weak to moderate. Conclusions: Our findings provide evidence for the influence of PS and DI on psychosocial symptoms and HRQOL, and emphasize the importance of psycho-oncological interventions that strengthen PS and prevent or reduce DI for patients with cancer and their relatives.