Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial.

BACKGROUND: Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehensive support services for affected families. The aim of this project is to implement and evaluate a complex psychosocial intervention for these families by providing advice, information, and care on an emotional, psycho-social, and communicative level during and after the cancer experience and across healthcare sectors. METHODS: Family-SCOUT is a project supported by the German Innovation Fund ( https://innovationsfonds.g-ba.de/ ). The evaluation is based on a mixed-methods quasi-experimental design with the intervention and control groups. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months of follow-up; T2: 9 months of follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. The study aim is to include n=560 families. Data will be analyzed according to the intention-to-treat principle. The primary analysis is the comparison of the Hospital Anxiety and Depression Scale (HADS) response rates (minimal important difference (MID) ≥ 1.6 in at least one of the two parents) at T2 between the intervention and control group using Fisher's exact test. The conduct of the study as well as the development and implementation of the intervention will be accompanied by comprehensive study monitoring following the principles of an effectiveness-implementation hybrid study. DISCUSSION: The results will allow to test the effectiveness and efficiency of the intervention for the target group. The first experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as the basis to assess the need of including the intervention in the catalog of services of the statutory health insurance funds in Germany. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04186923. Retrospectively registered on 4 December 2019.

Male Breast Cancer Patients' Perspectives on Their Health Care Situation: A Mixed-Methods Study.

BACKGROUND: Male breast cancer is rare. No information was available on how male breast cancer patients (MBCPs) experience the health care they receive in Germany in a setting that is tailored to women. The aim of this study was to explore the health care situation of MBCPs from their perspectives. METHODS: The study follows a mixed-methods design, combining quantitative data from a standardized written questionnaire with qualitative data from personal interviews. Descriptive statistics (quantitative data) and qualitative content analysis (qualitative data) were used for data analysis. RESULTS: Questionnaires completed by 100 and personal interviews of 27 MBCPs were analyzed. Several men reported mainly positive experiences while others experienced shortcomings. These included delays in diagnosis, health care provider uncertainty about treatment (tamoxifen, radiation therapy), experiences of stigmatization, and issues of continuity of care including unclear responsibilities for aftercare and access challenges to breast-cancer-specific care in gynecology settings. CONCLUSIONS: The awareness of male breast cancer needs to be increased among the public, health care providers and researchers in order to avoid delays in diagnosis and reduce stigmatization and uncertainty about treatment. Health care structures ensuring access to gynecology care and clear responsibilities for aftercare need to be established.

Social Support of Male Breast Cancer Patients-a Mixed-Methods Analysis.

The aim of this study is to explore the social support of male breast cancer patients (MBCP) in Germany. In particular, three aspects of social support focus on (a) the used resources within the social environment, (b) the received support, and (c) the differences of used social support between MBCP. A mixed-methods design is applied including data of qualitative interviews (N = 27 MBCP) and a written questionnaire (N = 100 MBCP). MBCP use different resources of support from their social environment like partners, family, friends, colleagues, other breast cancer patients, and medical experts. Mostly, MBCP receive emotional and informational support. They often receive emotional support from their partners and informational support from medical experts. Different types of social support usage can be identified dependent on age, occupation, and severity of disease. The older the patients and the less the disease severity, the less social support MBCP use. Within cancer care, partners and the closer social environment should be included more as they are a key resource for MBCP. As health-care professions might also be an important resource of support for MBCP, further research should examine this resource.

Men With a "Woman's Disease": Stigmatization of Male Breast Cancer Patients-A Mixed Methods Analysis.

Male breast cancer (MBC) is rare and known as a typical woman's disease. This study is part of the N-MALE project (Male breast cancer: patient's needs in prevention, diagnosis, treatment, rehabilitation and follow-up-care) and aims to investigate how MBC patients (MBCP) feel about suffering from a "woman's disease," what character the stigmatization has, and how it can be prospectively reduced. Therefore, a mixed methods design is applied including data of N = 27 qualitative interviews with MBCP and quantitative data of N = 100 MBCP. Findings identify a diverse picture, as stigmatization varies between contexts and patients: Most stigmatization concentrates on sexual stigmatization and ignorance of MBC and mostly occurs in cancer care systems and work-related contexts. The level of stigmatization varies with age and amount of treatment methods received, as reported within the created typology of different MBCP stigma types. To prospectively reduce stigmatization in MBCP, more publicity of MBC is needed, as well as gender-neutral communication and information material.

Unmet information needs and limited health literacy in newly diagnosed breast cancer patients over the course of cancer treatment.

OBJECTIVE: To investigate unmet information needs in newly diagnosed breast cancer patients over the course of cancer treatment and its association with health literacy. METHODS: We present results from a prospective, multicenter cohort study (PIAT). Newly diagnosed breast cancer patients (N=1060) were surveyed directly after breast cancer surgery, 10 and 40 weeks later. Pooled linear regression modeling was employed analyzing changes in unmet information needs over time and its association with health literacy. RESULTS: Unmet information needs on side effects and medication and medical examination results and treatment options were high and increased during the first 10 weeks after breast cancer surgery. Considering health promotion and social issues, unmet information needs started high and decreased during post-treatment. Patients with limited health literacy had higher unmet information needs. CONCLUSION: Our results indicate a mismatch in information provision and breast cancer patients' information needs. Patients with limited health literacy may be at a distinct disadvantage in having their information needs met over the course of breast cancer treatment. PRACTICE IMPLICATIONS: Strategies are needed to reduce unmet information needs in breast cancer patients considering treatment-phase and health literacy and thereby enable them to better cope with their diseases.

Health literacy and fear of cancer progression in elderly women newly diagnosed with breast cancer--A longitudinal analysis.

OBJECTIVE: This study aims to investigate the distribution of health literacy levels and the association of health literacy with fear of cancer progression (FoP) over the course of cancer treatment in a sample of elderly women newly diagnosed with breast cancer. METHODS: The analyses are part of a prospective, multicenter cohort-study (PIAT) that took place in Germany between 2013 and 2014. Elderly women (aged 65 years and older) newly diagnosed with breast cancer completed validated measures of health literacy and FoP directly after the breast cancer surgery and 40 weeks later. Multivariate random-effects regression analysis for longitudinal data was applied to estimate the association of health literacy with FoP considering socio-demographic, clinical and psychosocial characteristics of the patients. RESULTS: About half of the elderly breast cancer patients in our sample were classified as having limited health literacy (inadequate and problematic levels). Inadequate and problematic health literacy were significantly associated with higher levels of FoP in the elderly breast cancer patients. CONCLUSION: Limited health literacy is an independent risk factor for increased FoP. PRACTICE IMPLICATIONS: Enhancing health literacy could contribute to reducing patients' cancer-related fears.