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

Abstract

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.

Families Affected by Parental Cancer: Quality of Life, Impact on Children and Psychosocial Care Needs

“…Besides support initiated by health care teams, families might benefit from support in daily life at home. Household help or social legal advice as well as children's books, brochures for affected families or organization of additional child care can be helpful for affected families ( 36 ). Moreover, children can be supported in daycare or school.…”

Caring for dependent children impacts practical and emotional problems and need for support, but not perceived distress among cancer patients

“…have developed an interprofessional training program for all clinical professional groups in which cancer patients with dependent children are treated 38 : In 3 hours, the cancer's effects on the family, in particular strains and resources of the children, are explored, and communication both with and within the families is facilitated. Family‐Scout is a support concept for cancer patients with dependent children that is currently being evaluated 39 . Family‐Scouts are specially trained health care professionals who provide transsectoral support with focus on (a) enhancement open communication in the family, (b) coordination of practical, social and additional psychological support, (c) ongoing supportive care after death of the parent (if the case).…”

Krebskranke Eltern mit minderjährigen Kindern

“…Abb. 2) wurde die im Rahmen des Modellprojekts implementierte Intervention einer Wirksamkeitsevaluation unterzogen [4]. Da sich im Rahmen des Modellprojekts der aktiv aufsuchende Zugang des Familien-Scouts bewährt hat, wurde er beibehalten: Die im onkologischen Bereich Tätigen (Ärzte, Pflege, Sozialarbeiter, Psychoonkologen) identifizieren die Patienten mit minderjährigen Kindern und fragen, ob ihre Kontaktdaten weitergegeben werden dürfen, damit das Projekt Familien-SCOUT aktiv auf sie zugehen kann (siehe .…”