This trial is active, not recruiting.

Condition cancer
Treatment stepped care
Sponsor University of Leipzig
Start date April 2012
End date December 2014
Trial size 800 participants
Trial identifier NCT01859429, NKP-332-026


The study will examine whether the provision of psychosocial support services for cancer patients in acute care can be optimized by the use of a structured combination of screening procedures with physician interviews and structured patient pathways.

There is strong evidence that a third of all cancer patients in acute care are suffering from mental health conditions and that a third expresses the need for professional psycho-oncological support.

However, physicians and nurses do not always identify these patients in need for support. Screening questionnaires are significantly better to identify distressed patients however the use of screenings alone does not necessarily improve the patients' emotional well-being.

Purpose of this study is to evaluate a psychosocial stepped care model which aims to decrease the patients' distress.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose health services research
Structured stepped requirement of psychosocial support
stepped care
Step 1: Screening for psychosocial distress Step 2: If a patient is moderately or highly distressed according to step 1, the physician performs a brief structured interview and arranges, if necessary, appropriate psychosocial care Step 3: psychosocial care as indicated by step 2
(No Intervention)
Unstructured requirement of psychosocial support

Primary Outcomes

Mental condition
time frame: from baseline until 6 months

Secondary Outcomes

Social functioning
time frame: from baseline until 6 months
Satisfaction with treatment
time frame: at discharge from acute care hospital, 6 months after admission to acute care hospital
Comorbid mental disorders
time frame: at discharge from acute care hospital, 6 months after admission to acute care hospital
Use of healthcare services
time frame: 6 months after admission to acute care hospital

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - patients in acute care for cancer - written informed consent - 18 years and older - ability to complete questionnaires Exclusion Criteria: - insufficient command of German

Additional Information

Official title Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by University of Leipzig.