Trial document




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  DRKS00004968

Trial Description

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Title

A psycho educational group intervention to support patient competence: a multicenter evaluation study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Studies in chronic diseases indicate effects of psycho educational trainings, but at the same time record a deficit of such trainings for cancer patients. Based on previous work at the Tumor Biology Center Freiburg under the direction of Prof. Dr. Weis the aim of this study is to develop and evaluate a patient education program to promote patients'competency in an ambulatory setting. First this will be exemplarily done for patients with breast and prostate cancer. The evaluation will be focused on the question which effects the training has on the patient competence compared to the standard care . The study will be conducted multicentric (5 cooperation partners).
The study is funded by "Deutsche Krebshilfe e.V.".

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Brief Summary in Scientific Language

Studies in chronic diseases indicate effects of the examined interventions but at the same time record a deficit of such interventions for cancer patients. The development of appropriate psycho educational interventions for cancer patients is considered as significant (BMG 2010). Based on the previous work at the Tumor Biology Center Freiburg under the direction of Prof. Dr. Weis the aim of this study is to develop and to evaluate a specific, psycho educational, structured and manualized group intervention to promote patients'competency exemplarily for patients with breast and prostate cancer. The intervention is offered in outpatient aftercare phase because of the arising supply requirements in this phase which is, for example, caused by shortening inpatient bed times. The major research issue is the examination of the short-term effects of the intervention for both target groups. Examined as target relevant aspects will be relevant aspects of patient competency, psychological well-being and quality of life. In addition, a paper-pencil evaluation of the process characteristics will be done. The trainers will be systematically trained before the intervention and supervised during the intervention to refer to their loyalty to the manual. The implementation of the study is based on a randomized controlled waiting group designs. Therefore the immediate group will be compared with the waiting group which receives the specific intervention program 6-8weeks later. Three data collection time-points are provided: T1 at baseline and before randomization, T2 directly after the intervention for the immediate group and in the corresponding interval for the waiting group and T3 directly after the intervention for the waiting group and in corresponding interval for the immediate group (6-8 weeks after their intervention). The recruitment of participants will be managed via the study center and five cooperating institutions. It is generally expected that their will be a significant difference directly after the intervention between the participants in the immediately group (T2) and the waiting group in refer to the target criteria. The multicenter evaluation study will be conducted over three years. The study is funded by the "Deutsche Krebshilfe e.V.".

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Organizational Data

  •   DRKS00004968
  •   2013/05/15
  •   2013/05/07
  •   yes
  •   Approved
  •   151/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   VfD_---_13_003085  ( Projektdatenbank Versorgungsforschung in Deutschland)
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Immediate / intervention group (N=178)
    With an average of 9 participants per training (minimum of 6 people, maximum 10 people) a total of 24 groups has to be carried out (i.e., per centre and per diagnostic category 3 interventions).
    The manualized psycho educational patient education consists of 6 self-contained, structured training sessions, with each of 120 minutes duration. The training will be arranged once per week (total duration 6 weeks). Contents are: session 1) handling diagnosis specific stress situations, session 2) health promotion, session 3) doctor-patient communication, session 4) dealing with progression and recurrence fears, session 5) dealing with progression and recurrence fears and session 6) use and activation of social resources. With the same educational requirements the group sessions differ
    by focusing the diagnosis and treatment-related characteristics as well as gender-specific experiences of both diagnostic groups, which is why two specific diagnostic manuals (breast- and prostate cancer) are developed and implemented.
  •   Waiting / control group (N=178) The participants of the waiting /control group receive the same training as the immediate / intervention group participants but with a time-delayed start of the training. So the start will be 6-8 weeks after the immediate/ intervention group has received the training.
    With an average of 9 participants per training (minimum of 6 people, maximum 10 people) a total of 24 groups has to be carried out (i.e., per centre and per diagnostic category 3 interventions).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Other
  •   Parallel
  •   N/A
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Primary Outcome

According to the intended effects of the training the primary outcome is the subscale 'ability to cope with emotional stress' of the self-assessment instrument for patient competency (FEPK-2-57) developed by Giesler & Weis (2008). The review of the achievement of objectives is based on the survey of the time points T1-T3: T1 after study inclusion and prior randomization, T2 after the end of training for immediate / intervention group or after an appropriate time of 6-8weeks for waiting / control group and T3 after 6-8 weeks for both groups. The completion of the data collection is planned at the beginning of the third year of the study.

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Secondary Outcome

As secondary outcome criteria other subscales of this instrument (FEPK-2-57) are used: intentional confrontation with the threat of cancer, self-confidence in dealing with clinicians / physicians and self-regulation. Moreover, the measuring of the fear of recurrence (PAF-KF), the experienced disease-related self-efficacy (CBI BD), the quality of life (EORTC QLQ-C30/Br23/PR25) and the psychological well-being and coping (PHQ-D) are intended. The review of the achievement of objectives is based on the survey of the time points T1-T3: T1 after study inclusion and prior randomization, T2 after the end of training for immediate / intervention group or after an appropriate time of 6-8weeks for waiting / control group and T3 after 6-8 weeks for both groups. The completion of the data collection is planned at the beginning of the third year of the study.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2013/12/01
  •   356
  •   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

The study exclusively includes primary diseased patients with breast cancer or prostate cancer who have been treated respectively with curative intention. This selection is made in the light of the fact that for tumor patients in a palliative a different training content is required as for patients in a curative situation. Inclusion criteria breast cancer patients: - Curatively treated patients with a primary diagnosis of breast cancer (T1-4, to N3, M0) - Breast-conserving surgery or mastectomy - Adjuvant treatment (chemotherapy, radiotherapy) completed Inclusion criteria prostate cancer patients: - Curative treated patients with a primary diagnosis of prostate cancer (T1-4, to N1, M0) - Surgery (prostatectomy) or primary curative radiotherapy - Adjuvant radiotherapy completed

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Exclusion Criteria

Excluded are patients whos cognitive limitations do not allow to participate in the study.
Exclusion citeria breast cancer patients: secondary cancers, other malignancy within the last 10 years, linguistic or cognitive limitations, which make it difficult to participate the participation in the training program, severe psychiatric illness (psychosis, dementia, etc.), current psychotherapy.
Exclusion criteria prostate cancer patient: patients without treatment under watchful waiting strategy, secondary cancers, other malignancy within the last 10 years, linguistic or cognitive limitations which make it difficult to participate in training program or impossible, severe psychiatric illness (psychosis, dementia, etc.), current psychotherapy

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Addresses

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    • Klinik für Tumorbiologie
    • Mr.  Prof. Dr.  Joachim  Weis 
    • Breisacher Str. 117
    • 79106  Freiburg i.Br.
    • Germany
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    • LVR - Klinikum Essen Kliniken und Institut der Universität Duisburg - Essen
    • Ms.  Dipl.-Psych.  Ulrike  Schultheis 
    • Postfach 10 30 43
    • 45030  Essen
    • Germany
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    • Psychosoziale Krebsberatungsstelle Freiburg
    • Mr.  Dipl.-Psych.  Thomas  Gilbrich 
    • Hauptstr. 5a
    • 79104  Freiburg i.Br.
    • Germany
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    • Zentrum für Psychosoziale Medizin des Universitätsklinikums Hamburg-Eppendorf Institut u. Poliklinik für Medizinische Psychologie
    • Mr.  Dr. phil.  Frank  Schulz-Kindermann 
    • Martini-Str. 52
    • 20246  Hamburg
    • Germany
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    • Koordinationsstelle Psychosoziale Versorgung von Tumorpatienten / Tumorzentrum Rheinland-Pfalz e.V.
    • Mr.  Dr. med  Werner  Andreas 
    • Am Pulverturm 13
    • 55101  Mainz
    • Germany
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    • Abteilung für Medizinische Psychologie und Medizinische Soziologie des Universitätsklinikums Leipzig
    • Ms.  Prof. Dr. phil.  Anja  Mehnert 
    • Philipp-Rosenthal-Straße 55
    • 04103  Leipzig
    • Germany
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    • Klinik für Tumorbiologie an der Universität Freiburg
    • Mr.  Prof. Dr.  Joachim  Weis 
    • Breisacherstr. 117
    • 79106  Freiburg i.Br.
    • Germany
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    • Klinik für Tumorbiologie an der Universität Freiburg
    • Ms.  M.A. Gesundheitspädagogin  Katrin  Nagel 
    • Breisacherstr. 117
    • 79106  Freiburg i.Br.
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebshilfe (DHK) Stiftung Deutsche KinderKrebshilfe Dr. Mildred Scheel Stiftung für Krebsforschung Mildred Scheel Kreis e.V.
    • Buschstraße 32
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/28
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Trial Publications, Results and other Documents

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