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.

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.

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.

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.

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.

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.