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Completed

NCT Number: NCT01859429

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Leipzig, Dept. Psychosomatic Medicine and Psychotherapy

Leipzig, 04103, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stepped care

Other

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

Primary outcomes

  1. Mental condition

    Time frame: from baseline until 6 months

    Hospital Anxiety and Depression Scale, HADS

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Acronym: STEPPEDCARE

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
May 21, 2013
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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