Factors influencing the development of distress in first-diagnosed visceral oncology patients.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035679

Enrollment

150

Registered

2025-02-03

Start date

2025-03-05

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

C15 C16 C17 C18 C19 C20 C22 C23 C24 C25

Interventions

Group 1: Observation group In this study, inpatients with a histologically confirmed first diagnosis of visceral cancer will be examined. The aim is to analyze factors influencing the emergence and de

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inpatients who recently received their first diagnosis of visceral cancer during the same hospital admission. Histological confirmation must have been established.

Exclusion criteria

Exclusion criteria: Minor patients. Recurrence. Other cancer types.

Design outcomes

Primary

Measure	Time frame
The study's primary endpoint is the change in the distress score, measured using the Distress Thermometer (DT). The measurement method is based on a standardized self-assessment, where patients rate their psychological distress on a scale from 0 (no distress) to 10 (maximum distress). A distress score of 5 or higher is considered clinically significant, indicating substantial distress. The DT is assessed at multiple time points: on Day 0 (shortly after the diagnosis is communicated) and daily from Day 1 onward for a maximum of three weeks during the inpatient stay. Daily measurements enable a dynamic analysis of the development of distress over time. The study examines which factors (e.g., demographic, social, clinical) are associated with higher or lower distress trajectories. Additionally, it evaluates whether psycho-oncological interventions lead to a reduction in distress scores.	—

Measure

Time frame

The study's primary endpoint is the change in the distress score, measured using the Distress Thermometer (DT). The measurement method is based on a standardized self-assessment, where patients rate their psychological distress on a scale from 0 (no distress) to 10 (maximum distress). A distress score of 5 or higher is considered clinically significant, indicating substantial distress. The DT is assessed at multiple time points: on Day 0 (shortly after the diagnosis is communicated) and daily from Day 1 onward for a maximum of three weeks during the inpatient stay. Daily measurements enable a dynamic analysis of the development of distress over time. The study examines which factors (e.g., demographic, social, clinical) are associated with higher or lower distress trajectories. Additionally, it evaluates whether psycho-oncological interventions lead to a reduction in distress scores.

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Secondary

Measure	Time frame
Fatigue, pain, sleep disturbances, loss of appetite, anxiety, sadness.	—

Countries

Germany

Contacts

Public ContactMartin Holtmann

Klinikum Bremerhaven-Reinkenheide, Medizinische Klinik !

martin.holtmann@klinikum-bremerhaven.de+49 471 299 3222

Outcome results

None listed

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