Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis (STEPPEDCARE)
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|ClinicalTrials.gov Identifier: NCT01859429|
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : June 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: Stepped Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1012 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||March 2015|
Experimental: Stepped Care
Structured stepped requirement of psychosocial support
Other: 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: Care as usual
Unstructured requirement of psychosocial support
- Mental condition [ Time Frame: from baseline until 6 months ]Hospital Anxiety and Depression Scale, HADS
- Social functioning [ Time Frame: from baseline until 6 months ]Role Functioning Subscale, EORTC QLQ-C30
- Satisfaction with treatment [ Time Frame: at discharge from acute care hospital, 6 months after admission to acute care hospital ]Quality of Care from the Patients Perspective, QPP
- Comorbid mental disorders [ Time Frame: at discharge from acute care hospital, 6 months after admission to acute care hospital ]Structured Clinical Interview for DSM-IV, SCID
- Use of healthcare services [ Time Frame: 6 months after admission to acute care hospital ]Questionnaire from the German Federal Health Survey (Bundesgesundheitssurvey)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859429
|University of Leipzig, Dept. Psychosomatic Medicine and Psychotherapy|
|Leipzig, Germany, 04103|
|Principal Investigator:||Susanne Singer, PhD||Johannes Gutenberg University of Mainz|