Integrated, cross-sectorial psycho-oncology
Organizational Data
- DRKS-ID:
- DRKS00015326
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2018-10-30
- Last update in DRKS:
- 2019-01-15
- Registration type:
- Prospective
Acronym/abbreviation of the study
isPO
URL of the study
Brief summary in lay language
Every year, an estimated 420,000 people are diagnosed with cancer. Along with the bodily distress, the diagnosis of cancer and its treatment can impose significant emotional and psychological burdens on the affected persons. However, stable emotional and psychological circumstances of cancer patients can support the effectiveness of medical therapies and thereby the chances of recovery. The isPO project aims to reduce uncertainties, anxiety, and depression of cancer patients and promote self-help. For this purpose, the participating GPs and specialist practices as well as participating hospitals in the supply networks will work closely together at 4 locations in North Rhine-Westphalia. The so-called psycho-oncological care will involve people who have previously been affected by cancer, psychosocial specialists (including social workers), and psychotherapists. Patients are assigned to one of four levels of care using early detection tools (questionnaires). In accordance with their individual needs, patients will receive information on questions related to cancer ("All about Cancer") from a person who has previously been affected by cancer. Patients will be supported by a psychosocial specialist or a psychotherapist. Throughout this procedure, the isPO project will offer individualized care tailored to the needs of the patients. The project aims to achieve the following goals: Patient-related goal: reduction of the psychological stress reactions (anxiety and depression) of cancer patients within the first year after initial diagnosis. System-related goal: to provide a high-quality psycho-oncological care program for the cross-sectoral care of cancer patients.
Brief summary in scientific language
Until now, a cross-sectoral, psycho-oncological care had not yet been implemented in Germany, and the existing services were only made available to a small number of patients. Therefore, an integrated, cross-sectoral psycho-oncological care of patients with an initial cancer diagnosis will be developed, implemented and evaluated over a project period of 48 months in the administrative districts of Cologne and Düsseldorf at four care networks (oncological centers and general practitioners). The program is based on the recommendations of the S3-Guideline, "Psycho-oncological Diagnostics, Counseling, and Treatment of Adult Cancer Patients" and the objectives of the National Cancer Plan. Depending on their individual needs, patients will receive psychosocial and / or psycho-onco-psychotherapeutic care, including cancer self-help. For this purpose, the patients are assigned to one of the four levels of care after a psychological screening in order to ensure an individualized, needs-based care. Through a quasi-experimental design study using a regression discontinuity design (RDD), a control and an intervention group will be compared with a primary endpoint of the clinically significant reduction of anxiety and depression after 12 months, measured by the Hospital Anxiety and Depression scale (HADS). Patients receiving a tiered psychosocial care (control group; stage 1 and 2) will be compared with patients receiving a tiered psycho-oncological-psychotherapeutic care (intervention group, levels 3a and 3b). The RDD is based on the assumption of local randomization at the threshold value. Using the RDD, the HADS threshold > 14 will be analyzed for discontinuity and thus an effect of treatment. In addition, the approaches of cancer self-help, psychosocial care, and psycho-oncological psychotherapy will be brought together, operationalized and integrated into oncological care practice in a unified care concept. Authoritative care structures of a network of facilities in the inpatient and outpatient sectors will be formed. In addition to the supply concept, a quality management system and an IT-supported documentation system are being developed. For a comprehensive assessment, the new form of care will be evaluated prospectively, formatively, and summatively on the basis of a mixed-methods design. In addition to the quality of the structure, process, and results, the program effectiveness and the implementation of the program will also be evaluated. For this purpose, the satisfaction, expectations, and experiences of patients and employees will be comprehensively analyzed on the basis of surveys and interviews within the framework of the external evaluation. The results of the evaluation will be incorporated into the continuous optimization of the isPO program. Upon successful completion and positive evaluation, the program will be made available for widespread dissemination and implementation.
Health condition or problem studied
- ICD10:
- C00-C97 - Malignant neoplasms
- Free text:
- Depression, anxiety, psychosocial problems
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Stage 1: Consultation by onco-guides (briefing and provision of home-based information material on self-help offers).
- Arm 2:
- Stage 2: Psychosocial care (activation by a psychosocial specialist to make use of support services, preparation and implementation of a psychosocial help plan adapted to individual needs).
- Arm 3:
- Stage 3a: Psycho-oncological-psychotherapeutic care (psycho-oncological one-to-one treatment sessions with licensed psychotherapists to identify and modify dysfunctional cognitions and behaviors to reduce depression and anxiety).
- Arm 4:
- Stage 3b: Psycho-oncological-psychotherapeutic and psychosocial care (psycho-oncological one-to-one treatment sessions with licensed psychotherapists to identify and modify dysfunctional cognitions and behaviors to reduce depression and anxiety, while activating the use of support services by a psychosocial specialist, creating and implementing a psychosocial care plan adapted to individual needs).
Endpoints
- Primary outcome:
- The primary endpoint are depression and anxiety of patients after 12 months as measured by the Hospital Anxiety and Depression Scale (HADS).
- Secondary outcome:
- Secondary outcomes are: 1. The use of emotion regulation strategies (as measured by the Cognitive-Emotional Engagement with Cancer questionnaire (KEA-K)) and the reduction of psychosocial risks (as measured by the Psychosocial Risks questionnaire (PSR)) related to the cancer, measured at T1, T2, and T3. 2. The structural quality, process quality, and quality of care from the perspective of employees and patients as well as inhibiting and promoting factors of implementation: postal surveys of patients (n = 3,484) on T2 and T3 and project-accompanying focus groups with patients (n = 4); postal surveys of the employees (n ~ 100) as well as project-accompanying focus groups (n = 8) and interviews with employees (n ~ 16). 3. Subgroup analyses: health-related influencing factors on the effectiveness of psycho-oncological care (secondary data analysis of statutory health insurance routine data).
Study Design
- Purpose:
- Health care system
- Allocation:
- Non-randomized controlled study
- Control:
-
- Other
- Phase:
- IV
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Centrum für Integrierte Onkologie (CIO) Köln Köln
- Medical center GFO Kliniken Troisdorf
- Medical center Kliniken Maria Hilf GmbH Mönchengladbach
- Medical center Johanna-Etienne-Krankenhaus gGmbH Neuss
Recruitment period and number of participants
- Planned study start date:
- 2018-11-01
- Actual study start date:
- 2019-01-15
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 3484
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Patients with an initial diagnosis of cancer and whose statutory health insurance has entered into a special care contract with the competent care network within the framework of isPO are included. Moreover, patients should have sufficient knowledge of the spoken and written German language and must be fully contractually capable (capable of making legal decisions).
Exclusion Criteria
People who do not have sufficient German skills in spoken and written language. Furthermore, patients are excluded if their clinical situation does not enable them to receive care in the framework of isPO.
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Köln, Klinik I für Innere Medizin, Bereich Klinische PsychoonkologiePsychoonkologische VersorgungsforschungPD Dr. Michael KuschKerpener Str. 6250937 KölnGermany
- Telephone:
- +49(0)221-478-87410
- Fax:
- +49(0)221-478-97191
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://innere1.uk-koeln.de/forschung/arbeitsgruppen-labore/ag-psychoonkologische-versorgungsforschung/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Köln, Klinik I für Innere Medizin, Bereich Klinische PsychoonkologiePsychoonkologische VersorgungsforschungPD Dr. Michael KuschKerpener Str. 6250937 KölnGermany
- Telephone:
- +49(0)221-478-87410
- Fax:
- +49(0)221-478-97191
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://innere1.uk-koeln.de/forschung/arbeitsgruppen-labore/ag-psychoonkologische-versorgungsforschung/
Contact for Public Queries
- Address:
- Universitätsklinikum Köln, Klinik I für Innere Medizin, Bereich Klinische PsychoonkologiePsychoonkologische VersorgungsforschungPD Dr. Michael KuschKerpener Str. 6250937 KölnGermany
- Telephone:
- +49(0)221-478-87410
- Fax:
- +49(0)221-478-97191
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://innere1.uk-koeln.de/forschung/arbeitsgruppen-labore/ag-psychoonkologische-versorgungsforschung/
Principal Investigator
- Address:
- Universitätsklinikum Köln, Klinik I für Innere Medizin, Bereich Klinische PsychoonkologiePsychoonkologische VersorgungsforschungPD Dr. Michael KuschKerpener Str. 6250937 KölnGermany
- Telephone:
- +49(0)221-478-87410
- Fax:
- +49(0)221-478-97191
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://innere1.uk-koeln.de/forschung/arbeitsgruppen-labore/ag-psychoonkologische-versorgungsforschung/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Innovationsausschuss beim Gemeinsamen BundesausschussWegelystraße 810623 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://innovationsfonds.g-ba.de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät der Universität zu KölnGleueler Str. 26950935 KölnGermany
- Telephone:
- +49-221-478 82900
- Fax:
- +40-221-478 82905
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-03-21
- Ethics committee number:
- 18-092
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-10-15
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Prüfergebnisse für die Studie DRKS00015326
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- Kusch, Labouvie & Hein-Nau (2013). Klinische Psychoonkologie. Berlin, Heidelberg: Springer. Doi: 10.1007/978-3-642-31748-4
- Kusch, Labouvie, Gerlach, Hellmich & M. Hallek (2016). Übersicht – Kommt die personalisierte Psychoonkologie? TumorDiagnostik und Therapie, 37(10), 560-564. Doi: 10.1055/s-0042-118685
- Nationaler Krebsplan
- Bor J, Moscoe E, Mutevedzi P, et al. Regression discontinuity designs in epidemiology: causal inference without randomized trials. Epidemiology 2014;25(5):729-37. doi: 10.1097/EDE.0000000000000138
- Moscoe E, Bor J, Bärnighausen T. Regression discontinuity designs are underutilized in medicine, epidemiology, and public health: a review of current and best practice. Journal of Clinical Epidemiology 2015;68(2):122-33. doi: 10.1016/j.jclinepi.2014.06.021
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Bussmann & Vaganian, Kusch, Labouvie, Gerlach & Cwik (2018). Angst und Emotionsregulation bei Krebspatienten. Psychotherapeut, 63(3), 194-203. Doi: 10.1007/s00278-018-0283-3
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry