Comprehensive support for families with parental cancer – Family-SCOUT: study protocol for the evaluation of a complex intervention

Abstract

\n 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 method quasi-experimental design with intervention and control group. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months follow-up; T2: 9 months follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. 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: Results will allow to test the effectiveness and efficiency of the intervention for the target group. First experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as basis to assess the need of including the intervention in the catalogue of services of the statutory health insurance funds in Germany. Trial registration: ClinicalTrials.gov, NCT04186923. Retrospectively registered on 4 December 2019.