Assesment and optimising psychosocial care for persons with Li-Fraumeni syndrome and their relatives as part of the intensified screening and follow-up programme

Recruiting

• Conditions: Cancer predispostionPathogenic TP53 germline variant; Malignant neoplasms of independent (primary) multiple sites; C97; Z80; Family history of malignant neoplasm

• Registration Number: DRKS00021040
• Lead Sponsor: niversitätsfrauenklinik Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Diagnosis of LFS, Li-Fraumeni-Like-Syndrome, pathogenic TP53 germline variant
- OR
- Relatives (relative, partner, close person)
- From the age of 18
- German as mother tongue or very good knowledge of German
- Existence of an informed written consent to participate in the study

Exclusion Criteria

unclassified variant in the TP 53 germline (VUS), <18 years, not able to provide written informed consent, missing buisness capability, no sufficeint german language skills, unablility to pariticpate in interviews or answer questionairs, missing informed consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim of this study is:<br>a) the needs assesment for improving the medical and psychosocial care of people with LFS and their close relatives, who form the overall study group.<br>b) Feasibility and adherence to app support by the surveillance for people with LFS.<br>c) What is the state anxiety trend of people with LFS in respect to the surveillancve?

Secondary Outcome Measures

Name	Time	Method
Secondary target criteria<br>1. Cancer worry <br>2. Qualitiy of Life <br>3. To what extent occur psychopathologies in those affected or related personals?