Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis
STEPPEDCARE
1 other identifier
interventional
1,012
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Apr 2012
Typical duration for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 17, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJune 25, 2018
June 1, 2018
2.7 years
May 17, 2013
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mental condition
Hospital Anxiety and Depression Scale, HADS
from baseline until 6 months
Secondary Outcomes (4)
Social functioning
from baseline until 6 months
Satisfaction with treatment
at discharge from acute care hospital, 6 months after admission to acute care hospital
Comorbid mental disorders
at discharge from acute care hospital, 6 months after admission to acute care hospital
Use of healthcare services
6 months after admission to acute care hospital
Study Arms (2)
Stepped Care
EXPERIMENTALStructured stepped requirement of psychosocial support
Care as usual
NO INTERVENTIONUnstructured requirement of psychosocial support
Interventions
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
Eligibility Criteria
You may qualify if:
- patients in acute care for cancer
- written informed consent
- years and older
- ability to complete questionnaires
You may not qualify if:
- \- insufficient command of German
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Leipzig, Dept. Psychosomatic Medicine and Psychotherapy
Leipzig, 04103, Germany
Related Publications (4)
Singer S, Danker H, Briest S, Dietrich A, Dietz A, Einenkel J, Papsdorf K, Lordick F, Meixensberger J, Mossner 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.
PMID: 25491069BACKGROUNDSinger S, Danker H, Roick J, Einenkel J, Briest S, Spieker H, Dietz A, Hoffmann I, Papsdorf K, Meixensberger J, Mossner 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.
PMID: 28665542BACKGROUNDSinger S, Roick J, Meixensberger J, Schiefke F, Briest S, Dietz A, Papsdorf K, Mossner 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.
PMID: 29270828BACKGROUNDSinger S, Danker H, Meixensberger J, Briest S, Dietz A, Kortmann RD, Stolzenburg JU, Kersting A, Roick J. Structured multi-disciplinary psychosocial care for cancer patients and the perceived quality of care from the patient perspective: a cluster-randomized trial. J Cancer Res Clin Oncol. 2019 Nov;145(11):2845-2854. doi: 10.1007/s00432-019-03018-7. Epub 2019 Sep 10.
PMID: 31506739DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Susanne Singer, PhD
Johannes Gutenberg University of Mainz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Susanne Singer, Prof. PhD MSc Epidemiology
Study Record Dates
First Submitted
May 17, 2013
First Posted
May 21, 2013
Study Start
April 1, 2012
Primary Completion
December 1, 2014
Study Completion
March 1, 2015
Last Updated
June 25, 2018
Record last verified: 2018-06