Clinical trial NCT01859429: Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis
Official title: Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer patients
Psycho-oncological Care Provision
Structured Screening
Stepped care
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 1012
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Mental condition
timeFrame: from baseline until 6 months
Secondary outcomes:
measure: Social functioning
timeFrame: from baseline until 6 months
measure: Satisfaction with treatment
timeFrame: at discharge from acute care hospital, 6 months after admission to acute care hospital
measure: Comorbid mental disorders
timeFrame: at discharge from acute care hospital, 6 months after admission to acute care hospital
measure: Use of healthcare services
timeFrame: 6 months after admission to acute care hospital
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig, Dept. Psychosomatic Medicine and Psychotherapy
Study officials:
affiliation: Johannes Gutenberg University of Mainz
name: Susanne Singer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Singer 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.
citation: Singer 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.
citation: Singer 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.