Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis (STEPPEDCARE)

June 20, 2018 updated by: Susanne Singer, University of Leipzig

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1012

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • University of Leipzig, Dept. Psychosomatic Medicine and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental condition
Time Frame: from baseline until 6 months
Hospital Anxiety and Depression Scale, HADS
from baseline until 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social functioning
Time Frame: from baseline until 6 months
Role Functioning Subscale, EORTC QLQ-C30
from baseline until 6 months
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
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
Structured Clinical Interview for DSM-IV, SCID
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
Questionnaire from the German Federal Health Survey (Bundesgesundheitssurvey)
6 months after admission to acute care hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Principal Investigator: Susanne Singer, PhD, Johannes Gutenberg University of Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

May 17, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 21, 2013

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NKP-332-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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