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

Cancer Clinical Trial

— STEPPEDCARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859429
• Other study ID #: NKP-332-026
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2018
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1012
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
Germany	University of Leipzig, Dept. Psychosomatic Medicine and Psychotherapy	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Singer S, Danker H, Briest S, Dietrich A, Dietz A, Einenkel J, Papsdorf K, Lordick F, Meixensberger J, Mössner J, Niederwieser D, Prietzel T, Schiefke F, Stolzenburg JU, Wirtz H, Kersting A. Effect of a structured psycho-oncological screening and treatment model on mental health in cancer patients (STEPPED CARE): study protocol for a cluster randomized controlled trial. Trials. 2014 Dec 10;15:482. doi: 10.1186/1745-6215-15-482. — View Citation

Singer S, Danker H, Roick J, Einenkel J, Briest S, Spieker H, Dietz A, Hoffmann I, Papsdorf K, Meixensberger J, Mössner J, Schiefke F, Dietel A, Wirtz H, Niederwieser D, Berg T, Kersting A. Effects of stepped psychooncological care on referral to psychosocial services and emotional well-being in cancer patients: A cluster-randomized phase III trial. Psychooncology. 2017 Oct;26(10):1675-1683. doi: 10.1002/pon.4492. Epub 2017 Jul 20. — View Citation

Singer S, Roick J, Meixensberger J, Schiefke F, Briest S, Dietz A, Papsdorf K, Mössner J, Berg T, Stolzenburg JU, Niederwieser D, Keller A, Kersting A, Danker H. The effects of multi-disciplinary psycho-social care on socio-economic problems in cancer patients: a cluster-randomized trial. Support Care Cancer. 2018 Jun;26(6):1851-1859. doi: 10.1007/s00520-017-4024-x. Epub 2017 Dec 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental condition	Hospital Anxiety and Depression Scale, HADS	from baseline until 6 months
Secondary	Social functioning	Role Functioning Subscale, EORTC QLQ-C30	from baseline until 6 months
Secondary	Satisfaction with treatment	Quality of Care from the Patients Perspective, QPP	at discharge from acute care hospital, 6 months after admission to acute care hospital
Secondary	Comorbid mental disorders	Structured Clinical Interview for DSM-IV, SCID	at discharge from acute care hospital, 6 months after admission to acute care hospital
Secondary	Use of healthcare services	Questionnaire from the German Federal Health Survey (Bundesgesundheitssurvey)	6 months after admission to acute care hospital