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Trial record 1 of 1 for:    NCT01859429
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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
Sponsor:
Information provided by (Responsible Party):
Susanne Singer, University of Leipzig

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1012 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Mental condition [ Time Frame: from baseline until 6 months ]
    Hospital Anxiety and Depression Scale, HADS


Secondary Outcome Measures :
  1. Social functioning [ Time Frame: from baseline until 6 months ]
    Role Functioning Subscale, EORTC QLQ-C30

  2. 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

  3. 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

  4. Use of healthcare services [ Time Frame: 6 months after admission to acute care hospital ]
    Questionnaire from the German Federal Health Survey (Bundesgesundheitssurvey)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
University of Leipzig, Dept. Psychosomatic Medicine and Psychotherapy
Leipzig, Germany, 04103
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Susanne Singer, PhD Johannes Gutenberg University of Mainz
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Susanne Singer, Susanne Singer, Prof. PhD MSc Epidemiology, University of Leipzig
ClinicalTrials.gov Identifier: NCT01859429    
Other Study ID Numbers: NKP-332-026
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Keywords provided by Susanne Singer, University of Leipzig:
Cancer patients
Psycho-oncological Care Provision
Structured Screening
Stepped care