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

NCT ID: NCT01859429

Last Updated: 2018-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1012 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Stepped Care

Structured stepped requirement of psychosocial support

Group Type EXPERIMENTAL

Stepped Care

Intervention Type 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

Care as usual

Unstructured requirement of psychosocial support

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Susanne Singer

Susanne Singer, Prof. PhD MSc Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanne Singer, PhD

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg University of Mainz

Locations

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University of Leipzig, Dept. Psychosomatic Medicine and Psychotherapy

Leipzig, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 25491069 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28665542 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29270828 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31506739 (View on PubMed)

Other Identifiers

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NKP-332-026

Identifier Type: -

Identifier Source: org_study_id

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