Trial document




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  DRKS00015326

Trial Description

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Title

Integrated, cross-sectorial psycho-oncology

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Trial Acronym

isPO

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URL of the Trial

http://www.ispo.info

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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.

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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.

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Organizational Data

  •   DRKS00015326
  •   2018/10/30
  •   [---]*
  •   yes
  •   Approved
  •   18-092, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
  •   Depression, anxiety, psychosocial problems
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Interventions/Observational Groups

  •   Stage 1: Consultation by onco-guides (briefing and provision of home-based information material on self-help offers).
  •   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).
  •   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).
  •   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).
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Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health care system
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

The primary endpoint are depression and anxiety of patients after 12 months as measured by the Hospital Anxiety and Depression Scale (HADS).

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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).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/01/15
  •   3484
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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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).

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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.

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Addresses

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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Wegelystraße 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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* This entry means the parameter is not applicable or has not been set.