Evaluation of a cognitive-behavioral and systemic-solution-oriented short-term intervention to cope with fear of progression in families with children with cancer entitledShared fear, brave together
Phase 2
- Conditions
- fear of progression
- Registration Number
- DRKS00024106
- Lead Sponsor
- Selbstständige Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
Children aged 0 to 17 years with a diagnosis of cancer and/or a parent or primary caregiver (e.g. legal guardian where applicable).
Patients in inpatient treatment at the pediatric oncology ward of the University Hospital Leipzig or in the aftercare phase at the association Elternhilfe für krebskranke Kinder Leipzig e.V.
Children and parents with sufficient German language skills (at least language level B1 according to GER).
Declaration of informed consent to study participation.
Exclusion Criteria
Patients in palliative care.
Patients with cognitive or physical impairments that would limit participation in the intervention.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome variables are fear of progression of children and parents, assessed using the short form of the fear of progression questionnaire for children with cancer (FoP-Q-SF/C) and the short form of the fear of progression questionnaire for parents of children with cancer (FoP-Q-SF/PR).<br>The evaluation of the intervention (N=24 participants and/or one parent/main caregiver) is designed with a waiting control group and three measurement times: baseline (BL), post measurement after the intervention or after a waiting period (t1) and another measurement 4 months after completion of participation in the intervention (t2).
- Secondary Outcome Measures
Name Time Method Secondary outcome variables for children are anxiety, depression, post-traumatic stress, quality of life, and emotion regulation strategies. Secondary outcome variables for parents are anxiety and depression, post-traumatic stress, and quality of life. The socio-demographic background of the child and the parents as well as medical information about the cancer are also collected.