Post-traumatic distress syndrome in childhood cancer patients undergoing hematopoietic stem cell transplantation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036480

Enrollment

Registered

2025-06-17

Start date

2025-04-07

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F43.1

Interventions

Group 1: In a prospective study of 50 children, aged between 5 - 22 years, receiving hematopoietic stem cell transplantation (HSCT) and/or specific cell therapy, the occurrence of PTSD will be investi

Eligibility

Sex/Gender

All

Age

5 Years to 22 Years

Inclusion criteria

Inclusion criteria: - malignant or non-malignant diseases - upcoming allogeneic or autologous HSCT and/or specific cell therapy

Exclusion criteria

Exclusion criteria: - pre-existing psychological disorder

Design outcomes

Primary

Measure	Time frame
- PTSD, self-efficacy, health-related quality of life and distressing symptoms during patient therapy from the patient's perspective. Collected at the eight time points mentioned above using standardized questionnaires (see above). - Assessment of PTSD, health-related quality of life, personality traits and distressing symptoms of patients from the parents' perspective. Collected at the eight time points mentioned above using standardized questionnaires (see above). - Assessment of the physical stress level based on the cortisol/TSH/fT3/fT4 plasma concentrations in the peripheral blood. Determined at the same eight points in time during the morning blood sample.	—

Measure

Time frame

- PTSD, self-efficacy, health-related quality of life and distressing symptoms during patient therapy from the patient's perspective. Collected at the eight time points mentioned above using standardized questionnaires (see above). - Assessment of PTSD, health-related quality of life, personality traits and distressing symptoms of patients from the parents' perspective. Collected at the eight time points mentioned above using standardized questionnaires (see above). - Assessment of the physical stress level based on the cortisol/TSH/fT3/fT4 plasma concentrations in the peripheral blood. Determined at the same eight points in time during the morning blood sample.

—

Secondary

Measure	Time frame
• Correlation of PTSD and quality of life from the patient's and parents' perspective with measured stress biomarkers • Identification of personality-related factors (personality traits, self-efficacy, health-related quality of life, burdensome symptoms during therapy) that influence the occurrence of PTSD • Identification of sociodemographic and medical risk factors (e.g. age, gender, risk stratification of the underlying disease, length of hospital stay, etc.) for the development of PTSD or reduction in quality of life • Correlation of self-evaluated and externally evaluated quality of life and PTSD	—

Measure

Time frame

• Correlation of PTSD and quality of life from the patient's and parents' perspective with measured stress biomarkers • Identification of personality-related factors (personality traits, self-efficacy, health-related quality of life, burdensome symptoms during therapy) that influence the occurrence of PTSD • Identification of sociodemographic and medical risk factors (e.g. age, gender, risk stratification of the underlying disease, length of hospital stay, etc.) for the development of PTSD or reduction in quality of life • Correlation of self-evaluated and externally evaluated quality of life and PTSD

—

Countries

Germany

Contacts

Public ContactLeonie Judd

Universitätsklinikum Tübingen

leonie.judd@med.uni-tuebingen.de0049 7071 29-83781

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026