KiTDS-CareRecruiting

A Study of the Support Needs of Families with Children Who Have a Syndrome Associated with an Increased Risk of Cancer

Gender
Women and men
Age
up to 18 years
Trial type
Observational
Line of therapy
all
Phase
—

What is this trial about?

The occurrence of tumor predisposition syndromes (TDS) can place a significant burden on affected children and their families. To date, there is a lack of comprehensive data on the care provided to these families in Germany. The goal of the KiTDS-Care study is to examine the current state of care for families with children who have a tumor predisposition syndrome and, based on this, to develop recommendations for improving the care provided to these families. Families with a child up to 18 years of age who has a TDS are eligible to participate.

Trial flow

Requirements

Diagnosis: Cancer predisposition syndromes

Age: 0–18 years

Line of therapy: Unabhängig von Therapielinie

Key inclusion criteria: no unreasonable mental or physical strain due to participation in the study; children and family members

Allocation

Einarmige Studie

Treatment

prospective cross-sectional studyOnline questionnaires for parents and children aged 11 and above + in-depth interviews with some of the parents and experts surveyed

Follow-up

Detailed description

Cancer predisposition syndromes (CPS) are genetic disorders that significantly increase the risk of developing certain types of cancer during childhood and adolescence. These include, for example, Li-Fraumeni syndrome. Approximately 10% of all children with cancer have a CPS. In addition to medical challenges, affected families often experience significant psychosocial stress, such as uncertainty about genetic risks, regular screenings, and the emotional process of coming to terms with the diagnosis. Currently, there is a lack of reliable data on the care situation for affected families in Germany.

The aim of this prospective cross-sectional study is to analyze the current state of care and the support needs of families with children who have a tumor predisposition syndrome and to derive concrete recommendations for improving care. No medications or new forms of therapy are being tested as part of this study. Data collection will take place in several phases using various methods (mixed-methods cross-sectional design). First, a systematic literature review will be conducted on known psychosocial burdens and gaps in care among affected families. Subsequently, parents and children aged 11 and older will complete online questionnaires on mental well-being, quality of life, coping strategies, and the use of existing support services. Finally, in-depth interviews will be conducted with a subset of the parents who were previously surveyed, as well as with experts from the care team, to gain a detailed understanding of emotional needs and gaps in psychosocial care. No repeat surveys or follow-up interviews are planned; data will be collected from participants only once. Families with a child up to age 18 who has TDS are eligible to participate in this study. Children aged 11 and older may also complete the online questionnaire. Participation is not permitted if it would impose an unreasonable psychological or physical burden.

Facts

  1. What condition: Tumor Predisposition Syndrome (TDS)
  2. Cancer characteristics: Children and adolescents up to age 18 with TDS and their families
  3. What the study investigates: systematic assessment of the care situation and psychosocial support needs of these families in Germany
  4. Study objective: to derive concrete recommendations for action to improve care for the affected families
  5. How long will the study last: planned end date September 30, 2027
  6. Study characteristics: prospective, multicenter, non-interventional, cross-sectional design; no medications or new forms of therapy are being tested

Trial sites

4 trial sites in Germany are listed.

  • Universitätsklinikum Augsburg

    Stenglinstraße 2, 86156 Augsburg

    Recruiting

  • Kinderonkologisches Netzwerk (KIONET) Bayern

    Bayern

    Status unknown

  • LMU Klinikum

    Active, not recruiting

  • Universitätsklinikum Erlangen

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.