Outpatient follow-up of tumour diseases through video-based value-oriented behavioural activation (ViVA): study protocol for a randomised controlled trial.

BACKGROUND: In Germany, approximately half a million people are diagnosed with cancer annually; this can be traumatic and lead to depression, anxiety, and adjustment disorders necessitating psycho-oncological intervention. Value-oriented behavioural activation, adopted from depression psychotherapy, aims to provide structured support to help patients adjust their personal values, goals, and activities within the context of their changed life situation. This trial aims to evaluate the effectiveness of video-based value-oriented behavioural activation against German S3-Guideline-compliant aftercare for cancer patients dealing with psychological distress. METHODS: This trial will use covariate-adaptive randomisation according to gender and type of tumour disease to assign participants to one of two study arms (value-oriented behavioural activation consisting of 12 manualised follow-up sessions delivered via video consultation vs. S3-Guideline-compliant aftercare comprising three supportive talks). Psychological strain, psychosocial distress, quality of life, work-related outcomes, fear of cancer recurrence, goal adjustment, satisfaction with the consultant-participant relationship, and rumination will be measured at baseline, twice during treatment, posttreatment, and at the 6-month follow-up. The target sample of 146 tumour patients experiencing high psychosocial distress will be recruited at the Rehazentrum Oberharz, Germany. DISCUSSION: This trial aims to test the effectiveness of value-oriented behavioural activation in aftercare for tumour patients, focusing on its capacity to reduce distress and the potential for long-term effects evaluated through a 6-month follow-up. The study's possible challenges include enrolling a sufficient sample and ensuring adherence to treatment, mitigated through in-person recruitment and rigorous training of staff. If successful, the results will be of high public health relevance, especially for psychotherapeutic care in rural areas and among patients with limited mobility considering the video-based approach of the trial. TRIAL REGISTRATION: This study was registered at the German Clinical Trials Register: DRKS00031900 on Sep 19, 2023.

Contextual effects of community capacity as a predictor for adolescent alcohol, tobacco, and illicit drug use: A multi-level analysis.

Adolescent substance use is a major public health issue that can result in enduring physical, psychological, and social consequences. This study seeks to examine the relationship between community capacity for prevention and the 4-week prevalence rate of substance use, including tobacco, alcohol, other drugs, and binge-drinking, among students in Germany ranging from grades 5 to 11. This study employed a cross-sectional design and used baseline data from 28 communities participating in the CTC-EFF study. The sample consisted of 7210 students who were surveyed about their substance use behavior. Additionally, 158 local key informants were surveyed on ten capacity domains, which included commitment, knowledge and skills, resources, leadership, inclusiveness, prevention collaboration, sectoral-collaboration, cohesion, problem-solving skills, and needs orientation. Furthermore, a total capacity score was calculated as the mean of the ten capacity domains. To examine the associations between community capacity and substance use behavior, logistic multi-level models were utilized. The analysis shows a negative association between community capacity (total score) and any substance use (OR = 0.28, 95% CI 0.12-0.56). Specifically, higher levels of total community capacity are associated with lower odds of alcohol use (OR = 0.30, 95% CI 0.13-0.80), tobacco use (OR = 0.09, 95% CI 0.01-0.60), and binge-drinking (OR = 0.67, 95% CI (0.46-0.99). Further analyses of distinct community capacity domains indicate that higher levels of sectoral-collaboration (OR = 0.62, 95% CI 0.37-0.97), knowledge and skills (OR = 0.74, 95% CI 0.40-0.79), resources (OR = 0.52, 95% CI 0.36-0.76), and problem-solving skills (OR = 0.71, 95% CI 0.36-0.89) are associated with lower odds of any substance use. The study findings suggest that community capacity is associated with substance use behavior, emphasizing the importance of capacity building in interventions targeting the reduction of substance use among adolescents.

Study protocol: a non-randomised community trial to evaluate the effectiveness of the communities that care prevention system in Germany.

BACKGROUND: The Communities That Care (CTC) prevention planning and implementation system trains communities throughout a five-phase cycle to (1) build capacity for prevention, (2) adopt science-based prevention, (3) assess the prevention needs of adolescents living in the community, (4) select, and (5) implement evidence-based programs according to their needs. After CTC proved to be effective and cost-effective in the U.S., it is being used by an increasing number of communities in Germany. The aim of this study is to evaluate the effectiveness and cost-effectiveness of CTC in Germany. METHODS: Communities in CTC-phases 1 to 3 (n = 21) and individually-matched comparison communities (n = 21) were recruited for a non-randomised trial. To assess long-term outcomes, (1) a cohort of 5th Grade students will be surveyed biennially concerning behaviours (antisocial behaviour and substance use) and well-being as well as risk and protective factors. Additionally, (2) biennial cross-sectional surveys will be conducted in 6th, 8th, 10th, and 11th Grade in each community. To assess short-term outcomes, a cohort of ten key informants per community will be surveyed biennially concerning adoption of science-based prevention, collaboration, community support and community norms. (4) In a cross-sectional design, all ongoing prevention programs and activities in the communities will be assessed biennially and data will be collected about costs, implementation and other characteristics of the programs and activities. (5) To monitor the CTC implementation, the members of the local CTC-boards will be surveyed annually (cross-sectional design) about team functioning and coalition capacity. Data analysis will include general and generalised mixed models to assess the average treatment effect of CTC. Mediation analyses will be performed to test the logical model, e.g., adoption of science-based prevention as a mediator for the effectiveness of the CTC approach. DISCUSSION: This is the first controlled study to evaluate the effectiveness of a comprehensive community prevention approach in Germany. Evaluating the effectiveness of CTC in Germany is an important prerequisite for further diffusion of the CTC approach. TRIAL REGISTRATION: This study was registered with German Clinical Trial Register: DRKS00022819 on Aug 18, 2021.

Risk of dosing errors in ART treatment: user experience of single- vs multi-use follitropin alfa pens.

Background: This user experience study evaluated the suitability of single-use versus multi-dose follitropin alfa pen injectors for self-administration by women undergoing fertility treatment.Methods: Twenty-four fertility patients and 19 specialist nurses were recruited in four European countries to assess their use of Bemfola (a single-use pen), Gonal-f®, and Ovaleap® (multi-use pens). Participants completed usability tests in which their performance in assembling and administering doses of each pen was assessed against defined critical steps for ensuring safe and correct administration.Results: Critical error rates among nurses were 4%, 40%, and 49% for Bemfola®, Ovaleap®, and Gonal-f®, respectively; and among patients were 7%, 16%, and 38%. The most frequently reported critical errors occurred with the multi-use pens and were incorrect/lack of priming and failure to check the dose window prior to setting a new dose. The need to 'top up' doses from a new pen or cartridge when a pen contained insufficient dose also caused errors. The single-use pens did not cause these errors. Overall, 63% of nurses and 67% of patients had most confidence in Bemfola® for correct dosing and self-administration.Conclusions: Single-use pens require fewer preparation and administration steps than multi-use pens and are associated with fewer critical handling errors.

Interactive effects of social network centrality and social identification on stress.

The present study aimed to integrate the social identity approach to health and well-being with social network analysis. Previous research on the effects of social network centrality on stress has yielded mixed results. Building on the social identity approach, we argued that these mixed results can be explained, in part, by taking into account the degree to which individuals identify with the social network. We hence hypothesized that the effects of social network centrality on stress are moderated by social identification. Using a full roster method, we assessed the social network of first-year psychology students right after the start of their study programme and three months later. The effects of network centrality (betweenness, closeness, eigenvector centrality) and social identification on stress were examined using structural equation models. As predicted, our results revealed a significant interaction between network centrality and social identification on stress: For weakly or moderately identified students, network centrality was positively related to stress. By contrast, for strongly identified students, network centrality was unrelated to stress. In conclusion, our results point to the perils of being well-connected yet not feeling like one belongs to a group.

Breast cancer incidence and mammography screening among resettlers in Germany.

BACKGROUND: European studies showed that women with a migration background are less likely to participate in mammography screenings than autochthonous women. However, the participation in the German mammography screening programme (MSP) among ethnic German migrants from countries of the former Soviet Union (called resettlers) is unclear so far. The aim of this study was to identify possible differences regarding MSP participation between resettlers from the FSU and the general German population. METHODS: Data from two independent, complementary studies from North Rhine-Westphalia, Germany (a retrospective cohort study 1994-2013; a cross-sectional study 2013/14) were used for comparisons between resettlers and the general population: Odds Ratios (ORs) for MSP participation utilizing the cross-sectional data and time trends of breast cancer incidence rates as well as Chi-Square tests for breast cancer stages utilizing the cohort data. RESULTS: Resettlers showed higher Odds to participate in the MSP than the general population (OR 2.42, 95% CI 1.08-5.42). Among resettlers, a large increase in incidence rates was observed during the MSP implementation (2005-2009), resulting in stable and comparable incidence rates after the implementation. Furthermore, pre-MSP implementation, the proportion of advanced breast cancer stages was higher among resettlers than in the German population, post-MSP implementation the proportion was comparable. CONCLUSIONS: MSP participating seems surprisingly high among resettlers. An explanation for the increased willingness to participate might be the structured invitation procedure of the MSP. However, the exact reasons remain unclear and future research is needed to confirm this hypothesis and rule out the possibility of selection bias in the cross-sectional study.

How specific is cognitive change? A randomized controlled trial comparing brief cognitive and mindfulness interventions for depression.

Objective: There is a debate in psychotherapy research as to whether different kinds of psychotherapy work through specific mechanisms of change. Particularly, it is questioned whether cognitive change is specific to cognitive therapy. This study aimed to answer this question by comparing a brief cognitive intervention with an active comparison intervention (i.e., brief mindfulness-based intervention) and by following strict methodological guidelines. Method: 72 currently depressed outpatients were randomized to either cognitive intervention (n = 39) or mindfulness-based intervention (n = 33). Automatic thoughts (negative self-statements, well-being, and self-confidence), dysfunctional attitudes (performance evaluation and approval by others) and depressive symptoms were assessed before and six times during treatment. Within-person and between-person mediation effects were analyzed using multilevel structural equation modeling. Results: There was no difference in cognitive change between the interventions. Negative self-statements and performance evaluations were significant mediators of the within-person effect of time on depressive symptoms, while the three other cognitive variables did not change. Conversely, change in depressive symptoms also mediated within-person cognitive change. Conclusion: Cognitive change seems to be a general rather than a specific mechanism of change. However, the mutual impact of cognitive and depressive change does not support a unidirectional causal model.

Do Women With High eHealth Literacy Profit More From a Decision Aid on Mammography Screening? Testing the Moderation Effect of the eHEALS in a Randomized Controlled Trial.

Background: Our decision aid on mammography screening developed according to the criteria of the International Patient Decision Aids Standards Collaboration increases knowledge compared to usual care. However, it remains unclear whether this decision aid is more effective in women with higher eHealth literacy. Our objective was to test whether the positive effect of the decision aid on knowledge is moderated by eHealth literacy. Methods: A total of 1,206 women aged 50 from Westphalia-Lippe, Germany, participated (response rate of 16.3%) in our study and were randomized to usual care (i.e., the standard information brochure sent with the programme's invitation letter) or the decision aid. eHealth literacy was assessed at baseline with the Electronic Health Literacy Scale (eHEALS); knowledge was assessed at baseline and post-intervention. First, we compared the 2-factor model of the German eHEALS (information-seeking and information-appraisal) found in previous research and the 3-factor model we hypothesized for decision aid use to the originally proposed 1-factor model. Second, we modeled the measurement model according to the superior factor model found in step one and tested whether the eHEALS moderated the effect of the decision aid on knowledge. Results: The 3-factor model of the eHEALS had a better model fit than the 1-factor or 2-factor model. Both information-seeking, information-appraisal, and information-use had no effect on knowledge post-intervention. All three interactions of the decision aid with information-seeking, information-appraisal, and information-use were not significant. Equally, neither education nor its interaction with the decision aid had an effect on knowledge post-intervention. Conclusion: The decision aid developed in this project increases knowledge irrespective of level of eHealth literacy. This means that not only women with high eHealth literacy profit from the decision aid but that the decision aid has been successfully conceptualized as a comprehensible information tool that can be used by women of varying eHealth literacy levels. Trial registration: German Clinical Trials Register DRKS00005176 (https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005176).

Development of the Informed Choice in Mammography Screening Questionnaire (IMQ): factor structure, reliability, and validity.

BACKGROUND: Informed choice is of ethical and practical importance in mammography screening. To assess the level to which decisions regarding such screening are informed is thus imperative, but no specific instrument has been available to measure informed choice in the German mammography screening programme. The aims of this study were to develop the Informed Choice in Mammography Screening Questionnaire (IMQ) and to find first evidence for the factor structure, reliability and validity of its different components. METHODS: The IMQ was sent to 17.349 women aged 50 in Westphalia-Lippe, Germany. The instrument has been developed after consideration of (1) the results of qualitative interviews on decision making in the mammography screening programme, (2) relevant literature on other informed choice instruments and (3) a qualitative study on influencing factors. The IMQ comprises 3 scales (attitude, norms, and barriers), 1 index (knowledge) and singular items covering intention to participate and sociodemographic variables. To assess the psychometric properties of the components of the IMQ, confirmatory factor and item response theory analyses were conducted. Additionally, reliability, validity and item statistics were assessed. RESULTS: 5.847 questionnaires were returned (response rate 33.7%). For attitude, the confirmatory factor analysis supported a one-factor structure. For norms, the model fit was not acceptable. Reliability levels were good with a Cronbach's α of.793 for attitude (4 items) and.795 for norms (5 items). For barriers, 9 items were deleted because of low discrimination indices; 6 items remained. The hypothesised assumption-subscale and the importance-subscale were confirmed, but these subscales showed poor reliabilities with Cronbach's α=.525 (4 items) and.583 (2 items). For the knowledge index, item response theory analysis showed that 6 out of 7 items were suitable. Hypotheses concerning the correlations between the different components were confirmed, which supported their convergent and divergent validity. CONCLUSION: The results of this study demonstrated that the IMQ is a multidimensional instrument. Further development of the barriers and norms scales is necessary. The IMQ can be utilised to assess the level of informed choices as well as influencing factors.

Telephone-Based Cognitive Behavioral Intervention Improves Dementia Caregivers' Quality of Life.

The present study examined the effects of a telephone-based cognitive behavioral intervention on dementia caregivers' quality of life (QoL). A total of 273 caregivers were randomly assigned to an intervention or control group. The intervention comprised 12 telephone sessions of individual cognitive behavioral therapy (CBT) over 6 months. At baseline, postintervention, and 6-month follow-up, QoL was assessed with the World Health Organization QoL-BREF, which measures perceived QoL for the domains physical health, psychological health, social relationships, and environment as well as overall QoL and satisfaction with general health. Intention-to-treat analyses using latent change models were performed. At postintervention, intervention group participants reported better overall QoL and satisfaction with general health as well as better physical and psychological health compared to control group participants. Together with existing evidence, the results suggest that the telephone CBT intervention does not only reduce impairments but also fosters improvements in health-related QoL.

Uptake of Gynecological Cancer Screening and Performance of Breast Self-Examination Among 50-Year-Old Migrant and Non-migrant Women in Germany: Results of a Cross-Sectional Study (InEMa).

Our aim was to provide data regarding uptake of gynecological early detection measures and performance of breast self-examinations among migrant women in Germany. Cross-sectional self-reported data were collected using paper-and-pencil questionnaires. Descriptive analyses, Chi square-tests, and logistic regression were applied. Results were adjusted for educational level. Of 5387 women, 89.9% were autochthonous, 4.1% German resettlers, 2.8% Turkish, 3.1% other migrants. Participation rates regarding cancer screening differed significantly, with the lowest proportion in Turkish migrants (65.0%), resettlers (67.8%), other migrants (68.2%) and autochthonous population (78.2%). No differences in performance of breast self-examinations were detected. When adjusted for education, results indicated only slight changes in the odds to participate in screening irregularly or not at all. Results support existing evidence by showing lower participation rates in cancer screening among migrant women, but there were no differences regarding breast self-examinations. Migrant women form a potential high-risk group for late-stage diagnosis of cervical or breast cancer.

Knowledge about mammography screening in Germany by education and migrant status ­ results of a cross-sectional study (InEMa)

Background: The population-based mammography screening program (MSP) is aimed to reduce breast cancer mortality, to detect breast cancer at an early stage, and to allow for less invasive treatment. However, it also has some potential harms, such as overdiagnosis and overtreatment. Therefore, it is necessary that women receive sufficient and balanced information to enable informed decision-making. We examined knowledge about benefits and harms of the MSP in Germany among first-time invitees of different socio-demographic backgrounds. Methods: This observational study assessed knowledge about benefits and harms of the MSP among women who were invited to the MSP for the first time by six multiple choice items, using a postal survey. We investigated (i) single items of knowledge, (ii) the distribution of sufficient knowledge stratified by education, migration status and invitation, and (iii) possible determinants of sufficient knowledge by analyzing Odds Ratios (ORs) using bivariate and multivariate logistic regression. Results: In total, 5397 women included in the analyses. 46.1% of the study population had sufficient knowledge about benefits and harms of the MSP. However, women with low educational level and migration background had higher proportions of insufficient knowledge and used most frequently the option "don't know". Women had the most difficulties answering the numeric question and the question about the target group correctly. Results from the logistic regression showed that the odds of having sufficient knowledge were higher among well-educated women (OR 3.84, 95%CI 3.24­4.55), among women who already received the MSP invitation (OR 1.38, 95%CI 1.20­1.59) and lowest among Turkish women (OR 0.14, 95%CI 0.07­0.25). Conclusions: Women with low education and migration background need adapted information regarding benefits and harms of the MSP and are important target groups for further developing the information material about mammography screening to reduce disparities in knowledge and enable informed decision-making (AU)

Crowd-figure-pictograms improve women's knowledge about mammography screening: results from a randomised controlled trial.

OBJECTIVE: To evaluate the effect of crowd-figure-pictograms on women's numeric knowledge about mammography screening in a three-armed parallel randomised controlled trial. RESULTS: 552 women were randomised to receive (1) non-numeric information (n = 192), (2) non-numeric and numeric information (n = 186), or (3) non-numeric and numeric information complemented by crowd-figure-pictograms (n = 174). Baseline numeric knowledge was low (control 0.61, numeric 0.66, and pictogram 0.51 on a scale ranging from 0 to 5). Women in the crowd-figure-pictogram group had a larger knowledge increase than women in the numeric group (2.42 vs 2.06, p = .03). Both groups had significant increases in knowledge compared to the control (0.20, p < .001). Providing numeric information in absolute numbers improves knowledge; even more so when crowd-figure-pictograms are added. Trial registration German Clinical Trials Register DRKS00014736, retrospectively registered 11 May 2018.

Intervention Helps Family Caregivers of People With Dementia Attain Own Therapy Goals.

INTRODUCTION: Caregiver intervention studies typically assess whether participants attain general goals (eg, improved mental/physical health) but not their own individual goals. We used goal attainment scaling to evaluate whether participants of a telephone intervention based on cognitive behavioral therapy (CBT) attained their personal goals. We also evaluated treatment compliance and implementation. METHODS: A sample of 139 family caregivers of people with dementia received 12 telephone sessions over 6 months. Participants personal goals were specified during the first and second sessions. Participants and therapists assessed goal attainment at the end of the intervention. RESULTS: Nearly all participants reported meaningful improvements with regard to their personal goals. Specifically, 20.9% exceeded, 56.4% completely attained, and 21.8% partially attained at least one of their personal goals. There was high agreement between self- and therapist ratings. Treatment compliance and implementation were highly satisfactory. CONCLUSIONS: The CBT telephone intervention successfully helped participants attain their personal goals.

The Tele.TAnDem Intervention: Telephone-based CBT for Family Caregivers of People With Dementia.

Background and Objectives: This study evaluated the effectiveness of a telephone-based cognitive-behavioral therapy for family caregivers of people with dementia in existing health care provision structures. Research Design and Methods: Two hundred seventy-three family caregivers of people with dementia were randomly assigned to receive the intervention or usual care. Usual care included unrestricted access to community resources. Intervention group participants received twelve 50-min sessions of individual cognitive-behavioral therapy by trained psychotherapists within 6 months. Symptoms of depression, emotional well-being, physical health symptoms, burden of care, coping with the care situation and challenging behavior were assessed after the intervention ended and at a 6-month follow-up. Intention-to-treat analyses using latent change models were applied. Results: Intention-to-treat analyses showed improved emotional well-being (γ = 9.59, p = .001), fewer symptoms of depression (γ = -0.23, p = .043), fewer physical health symptoms (γ = -0.25, p = .019), improved coping with the care situation (γ = 0.25, p = .005) and the behavior of the care recipient (γ = 0.23, p = .034) compared with usual care. Effects for coping (γ = 0.28, p = .006 and γ = 0.39, p < .001, respectively) and emotional well-being (γ = 7.61, p = .007) were also found at follow-up. Discussion and Implications: The CBT-based telephone intervention increased mental and physical health as well as coping abilities of family caregivers of people with dementia. The intervention can be delivered by qualified CBT therapists after an 8-h training session in existing health care provision structures.

Does a decision aid improve informed choice in mammography screening? Results from a randomised controlled trial.

BACKGROUND: Decision aids can support informed choice in mammography screening, but for the German mammography screening programme no systematically evaluated decision aid exists to date. We developed a decision aid for women invited to this programme for the first time based on the criteria of the International Patient Decision Aids Standards Collaboration. OBJECTIVE: To determine whether a decision aid increases informed choice about mammography screening programme participation. METHODS: A representative sample of 7,400 women aged 50 was drawn from registration offices in Westphalia-Lippe, Germany. Women were randomised to receive usual care (i.e., the standard information brochure sent with the programme's invitation letter) or the decision aid. Data were collected online at baseline, post-intervention, and 3 months follow-up. The primary outcome was informed choice. Secondary outcomes were the constituents of informed choice (knowledge, attitude, intention/uptake), decisional conflict, decision regret, and decision stage. Outcomes were analysed using latent structural equation models and χ2-tests. RESULTS: 1,206 women participated (response rate of 16.3%). The decision aid increased informed choice. Women in the control group had lower odds to make an informed choice at post-intervention (OR 0.26, 95% CI 0.18-0.37) and at follow-up (OR 0.66, 95% CI 0.46-0.94); informed choices remained constant at 30%. This was also reflected in lower knowledge and more decisional conflict. Post-intervention, the uptake intention was higher in the control group, whereas the uptake rate at follow-up was similar. Women in the control group had a more positive attitude at follow-up than women receiving the decision aid. Decision regret and decision stage were not influenced by the intervention. CONCLUSION: This paper describes the first systematic evaluation of a newly developed decision aid for the German mammography screening programme in a randomised controlled trial. Our decision aid proved to be an effective tool to enhance the rate of informed choice and was made accessible to the public. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005176.

Informed Choice in the German Mammography Screening Program by Education and Migrant Status: Survey among First-Time Invitees.

Breast cancer is the most prevalent cancer among women and mammography screening programs are seen as a key strategy to reduce breast cancer mortality. In Germany, women are invited to the population-based mammography screening program between ages 50 to 69. It is still discussed whether the benefits of mammography screening outweigh its harms. Therefore, the concept of informed choice comprising knowledge, attitude and intention has gained importance. The objective of this observational study was to assess the proportion of informed choices among women invited to the German mammography screening program for the first time. A representative sample of 17,349 women aged 50 years from a sub-region of North Rhine Westphalia was invited to participate in a postal survey. Turkish immigrant women were oversampled. The effects of education level and migration status on informed choice and its components were assessed. 5,847 (33.7%) women responded to the postal questionnaire of which 4,113 were used for analyses. 31.5% of the women had sufficient knowledge. The proportion of sufficient knowledge was lower among immigrants and among women with low education levels. The proportion of women making informed choices was low (27.1%), with similar associations with education level and migration status. Women of low (OR 2.75; 95% CI 2.18-3.46) and medium education level (OR 1.49; 95% CI 1.27-1.75) were more likely to make an uninformed choice than women of high education level. Turkish immigrant women had the greatest odds for making an uninformed choice (OR 5.30, 95% CI 1.92-14.66) compared to non-immigrant women. Other immigrant women only had slightly greater odds for making an uninformed choice than non-immigrant women. As immigrant populations and women with low education level have been shown to have poor knowledge, they need special attention in measures to increase knowledge and thus informed choices.

Does a decision aid improve informed choice in mammography screening? Study protocol for a randomized controlled trial.

BACKGROUND: When invited for the first time at age 50, most women in Germany have to decide whether they wish to participate in the German mammography screening programme. For ethical reasons, screening decisions should be informed choices, but this is rarely the case with mammography screening. Decision aids are interventions with the potential to support informed choice by improving the following factors: knowledge, clarity of personal attitude, and implementation of an intention. Currently, no systematically evaluated decision aid exists for the German mammography screening programme. Therefore, the objective of this randomized controlled trial is to assess the effectiveness of a decision aid for first-time mammography screening programme invitees. METHODS/DESIGN: We have developed a decision aid for women invited to the mammography screening programme for the first time based on the criteria of the International Patient Decision Aids Standards Collaboration. The effectiveness of the decision aid will be evaluated in a randomized controlled trial with a 3-month follow-up. We will invite 7400 women aged 50 years from the district of Westfalen-Lippe, Germany, to participate. This sample will be drawn from registration office data. The primary outcome will be informed choice. The secondary outcomes will be the components of informed choice (knowledge, attitude, decision/implementation). Decisional conflict, decision regret, eHealth literacy, health behaviours, perceived behavioural control, subjective norms, invitation status, and demographic variables will be assessed. Data will be collected online at baseline, post-intervention, and at the 3-month follow-up. Participants will be randomized to receive either the decision aid or usual care (invitation and standard leaflet of the mammography screening programme). DISCUSSION: This paper describes the evaluation of a decision aid for the German mammography screening programme in a randomized controlled trial. If the decision aid proves to be an effective tool to enhance the rate of informed choice, it will be made accessible to the public and the use of this decision aid for first-time invitees will be recommended. The long-term effect could be an improvement in informed choices in women invited to the mammography screening programme. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005176.

The Tele.TAnDem intervention: study protocol for a psychotherapeutic intervention for family caregivers of people with dementia.

BACKGROUND: Family caregivers are confronted with high demands creating a need for professional support and at the same time hindering its utilization. Telephone support allows easier access than face-to-face support because there is no need to leave the person with dementia alone or find an alternative carer. It is also independent of transport possibilities or mobility. The objectives are to evaluate whether telephone-based cognitive-behavioral therapy, which is implemented in established care provision structures, improves outcomes compared to usual care and whether it is as effective as face-to-face cognitive-behavioral therapy. METHODS/DESIGN: If participants live in the area of one of the study centers (Jena, Berlin, Munich) and indicate that attendance of a face-to-face therapy is possible, they will be assigned to the face-to-face group. The other participants will be randomized to receive either telephone-based cognitive-behavioral therapy or usual care. Data will be collected at baseline, post-intervention, and at a 6-month follow-up. The primary outcomes will be depressiveness, burden of care, health complaints, and problem-solving ability. The secondary outcomes will be anxiety, quality of life, violence in caregiving, utilization of professional assistance, and cost effectiveness. DISCUSSION: This paper describes the evaluation design of our telephone-based cognitive-behavioral therapy in a randomized controlled trial. If this intervention proves to be an effective tool to improve outcomes, it will be made accessible to the public and the use of this support service will be recommended. TRIAL REGISTRATION: German Clinical Trials Register DRKS00006355.

A cross-sectional study on informed choice in the mammography screening programme in Germany (InEMa): a study protocol.

INTRODUCTION: Breast cancer is the most prevalent cancer among women. In Germany, women are invited to a population-based mammography screening programme for the first time at the age of 50. Since it is still discussed whether the benefits of mammography screening outweigh its harms, the concept of informed choice has gained importance. The objective of this cross-sectional study is to assess the proportion of informed choices in the mammography screening programme. A special focus is on the examination of the impact of Turkish migration background and educational level on informed choices. METHODS AND ANALYSIS: The proportion of informed choices is evaluated in a cross-sectional study with 3-month follow-up for behavioural implementation of the screening intention. A randomly selected sample of 17,000 women aged 50 years living in Westphalia-Lippe, a region in the Federal State of North-Rhine Westphalia, is invited to participate in this study. To reach adequate numbers of Turkish women, all possibly Turkish women in the sample are identified through a name algorithm and contacted. The sample is drawn from women registered in the study area for which the registration offices consented to supply data for the study (88% of all towns/cities in the study region). Women identified through the Turkish name algorithm received all materials in German and Turkish. The primary outcome is informed choice. Data are collected on informed choice components (knowledge, attitude, decision/implementation) as well as on its possible determinants (eg, health behaviour, perceived behavioural control, subjective norms, invitation status, migration background and other demographic variables). Data are collected before the screening appointment and at 3 months follow-up. ETHICS AND DISSEMINATION: The study was approved by the ethical committee of the Medical Faculty of Muenster University. Results will be published in a relevant scientific journal and communicated to respondents and relevant institutions.