Assessing Psychosocial and Supportive Care Needs of Families With Children and Adolescents Diagnosed With Cancer Predisposition Syndromes: Protocol for the KiTDS-Care Mixed Methods Study.

Abstract

Cancer predisposition syndromes (CPSs) are identified in approximately 10% of pediatric patients with cancer, and the number of children known to be affected by CPSs is steadily increasing. Families of children and adolescents with a CPS face substantial psychosocial challenges, including uncertainty regarding genetic risk, communication, long-term surveillance requirements, and concerns about future health outcomes. Despite these challenges, little is known about the psychosocial burden, supportive care needs, and current care situation of affected families in Germany. The KiTDS-Care (Children with Tumor Predisposition Syndrome and their Families-Analysis of the current Care Situation and Support Needs, and Derivation of Care Recommendations) study aims to (1) comprehensively assess the current psychosocial care landscape, psychosocial burden, and supportive care needs of families with children and adolescents diagnosed with a CPS in Germany and (2) develop recommendations for improving psychosocial and family-centered care based on the study findings. KiTDS-Care is a mixed methods study. First, a systematic review will synthesize existing evidence on the psychosocial experiences and support needs of families affected by a CPS. Second, a nationwide cross-sectional survey will be conducted among parents and adolescents or children aged ≥7 years to assess depression, anxiety, quality of life, supportive care needs, and health care use using standardized questionnaires. Finally, qualitative semistructured interviews with families and health care professionals will explore psychosocial experiences, barriers to care, and perceived gaps in existing support services in greater depth. Quantitative data will be analyzed using descriptive and inferential statistical methods, while qualitative data will be analyzed using structured content analysis. On the basis of the integrated findings, recommendations for psychosocial care will be developed and refined with input from families and health care professionals. The study is funded by German Cancer Aid for 36 months from October 2024. Data collection for the systematic review began in January 2025. Recruitment for the cross-sectional survey and qualitative interviews started in May 2025 and will continue until April 2027. A sample of 90 families is planned. As of January 2026, participant recruitment is ongoing, and 52 participants from 24 families have been enrolled. Data analysis is expected to be completed in July 2027, and publication of the primary study results is anticipated in October 2028. The KiTDS-Care study will provide comprehensive insights into the psychosocial situation and supportive care needs of families affected by a CPS in childhood and adolescence. The findings are expected to identify gaps in current care structures and inform the development of targeted, family-centered psychosocial support services for affected families in Germany. German Clinical Trials Register DRKS00035594; http://drks.de/search/de/trial/DRKS00035594. DERR1-10.2196/91737.