CancerSTEPPEDCARENCT01859429
Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis
A study testing Stepped Care in people with Cancer, run by University of Leipzig at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Stepped Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,012 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients in acute care for cancer
- written informed consent
- 18 years and older
- ability to complete questionnaires
Who cannot join
- insufficient command of German
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Leipzig, Dept. Psychosomatic Medicine and Psychotherapy
Leipzig, 04103
About this study
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.
Read more
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.
- Conditions
- Cancer
- Being tested
- Stepped Care
- Keywords
- Cancer patients, Psycho-oncological Care Provision, Structured Screening, Stepped care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care | Experimental | Structured stepped requirement of psychosocial support Receives: Other: Stepped Care |
| Care as usual | No intervention | Unstructured requirement of psychosocial support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental condition
Hospital Anxiety and Depression Scale, HADS
Measured: from baseline until 6 months
Secondary outcomes (4)
Social functioning
Role Functioning Subscale, EORTC QLQ-C30
Measured: from baseline until 6 months
Satisfaction with treatment
Quality of Care from the Patients Perspective, QPP
Measured: at discharge from acute care hospital, 6 months after admission to acute care hospital
Comorbid mental disorders
Structured Clinical Interview for DSM-IV, SCID
Measured: at discharge from acute care hospital, 6 months after admission to acute care hospital
Use of healthcare services
Questionnaire from the German Federal Health Survey (Bundesgesundheitssurvey)
Measured: 6 months after admission to acute care hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Singer, University of Leipzig
- Investigators
- Susanne Singer, PhD, Principal investigator, Johannes Gutenberg University of Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859429
- Sponsor's protocol ID
- NKP-332-026
- Acronym
- STEPPEDCARE
- Status last verified
- Jun 2018
- First submitted
- 17 May 2013
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25491069Singer 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.
PubMed 28665542Singer 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.
PubMed 29270828Singer 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.
PubMed 31506739
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis
- ClinicalTrials.gov ID
- NCT01859429
- Acronym / sponsor ID
- STEPPEDCARE / NKP-332-026
- Conditions
- Cancer
- Keywords
- Cancer patients, Psycho-oncological Care Provision, Structured Screening, Stepped care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care | Experimental | Other: Stepped CareStructured stepped requirement of psychosocial support |
| Care as usual | No intervention | –Unstructured requirement of psychosocial support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients in acute care for cancer
- written informed consent
- 18 years and older
- ability to complete questionnaires
Key exclusion criteria (1 listed)
- insufficient command of German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped CareStep 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 | Other | Stepped Care |
Primary outcome
Mental condition
Time frame: from baseline until 6 months
Hospital Anxiety and Depression Scale, HADS
4 secondary outcomes
Social functioning
Time frame: from baseline until 6 months
Satisfaction with treatment
Time frame: at discharge from acute care hospital, 6 months after admission to acute care hospital
Comorbid mental disorders
Time frame: at discharge from acute care hospital, 6 months after admission to acute care hospital
Use of healthcare services
Time frame: 6 months after admission to acute care hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Background: PubMed 25491069Singer 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.
- Background: PubMed 28665542Singer 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.
- Background: PubMed 29270828Singer 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.
- Derived from this study: PubMed 31506739Singer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Singer, PhD principal investigator
Johannes Gutenberg University of Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Care in people with Cancer, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental condition (time frame: from baseline until 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859429, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.