Trial document




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  DRKS00014627

Trial Description

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Title

Evaluation of a patient-oriented decision aid and the German healthcare situation in non-metastatic prostate cancer

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Trial Acronym

EvEnt-PCA

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URL of the Trial

https://www.uniklinikum-dresden.de/event-pca

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Brief Summary in Lay Language

With 60,000 new diagnoses per year prostate cancer is the most common malignant disease in German men (Robert Koch Institute, 2016). There are various methods of treating prostate cancer, for example surgery, radiation, hormonotherapy or observation. Personal preferences and expectations also play an important role in the choice of the suitable treatment strategy. Some treatment methods can for example contain an increased risk of undesirable side effects. For this reason, the doctor and patient conduct an extensive personal consultation explaining the assets and drawbacks of various treatment options and detailed procedures. In order to give an overview of several treatment options to the patient mainly before the consultation with his urologist, information material is handed over, usually in the form of the " Patientenleitlinie/Patient Guideline" from the "Leitlinienprogramm Onkologie/ Guideline Program Oncology". The “PatientenAkademie” of “Deutsche Gesellschaft für Urologie e.V. / German Society of Urology” has developed an alternative to this leaflet since 2016, the so-called "Entscheidungshilfe Prostatakrebs/Decision Aid Prostate Cancer". This is an online information tool wherein the same content is explained in an interactive mode by using videos. In addition, the patient can enter all relevant information for the consultation in a standardized form. This is used to create a one-page summary that can serve as a basis for the following discussion.
The trial “EvEnt-PCA” will now investigate, whether the new video-based decision tool can offer an additional benefit to the classic paper-based "Patient Guideline". In addition, the data collection and outcome of the study can provide important insights on the routine care for patients with prostate cancer in Germany. A total of 1,500 patients are to be included in the randomized study. Only male patients in the age group 18-80 with histologically confirmed adenocarcinoma of the prostate and no clinical evidence of metastases (cM0 or cMx) are considered. Further inclusion criteria are PSA < 100 ng/ml, no primary treatment, and no participation in other PCA studies. In addition, the decision making process must not be completed yet and the patient must have Internet access and an E-mail address.
After the initial diagnosis, the attending physician offers study participation. After informed consent 750 patients are randomly assigned to use the Decision Aid Prostate Cancer or they receive the printed brochure. For the study physicians, the work load includes two survey dates (study inclusion and follow-up after 14 months). On the patient side, three survey dates are planned (intervention and follow-up after one and 14 months).

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Brief Summary in Scientific Language

The randomized trial "Evaluation of a patient-oriented decision aid and the German healthcare situation in non-metastatic prostate cancer" (EvEnt-PCA) will compare the "Entscheidungshilfe Prostatakrebs/Decision Aid Prostate Cancer" with the “Patientenleitlinie/Patient Guideline" as the current standard. The Decision Aid Prostate Cancer is an online information tool wherein the same content is explained in an interactive mode by using videos.
A total of 1,500 patients are to be included in the randomized study. Only male patients in the age group 18-80 with histologically confirmed adenocarcinoma of the prostate and no clinical evidence of metastases (cM0 or cMx) are considered. Further inclusion criteria are PSA < 100 ng/ml, no primary treatment, and no participation in other PCA studies. In addition, the decision making process must not be completed yet and the patient must have Internet access and an E-mail address.
The study course can easily be integrated into the clinical routine: After the initial diagnosis, the attending physician offers to the patient the possibility to participate in the study. A total of 750 patients are randomly assigned to use the Decision Aid Prostate Cancer or to receive the printed brochure. The primary end point is the use of deferred treatment strategies in accordance with the guideline recommendation. In addition, the intervention should also improve other qualities of decision making. Moreover, the perspective of the physician is included in the study.
Overall 1,500 patients are to be included in the two-armed randomized evaluation study. On the patient side, three survey dates are planned (intervention and follow-up after one and 14 months). The participating physicians complete two survey dates (study inclusion and follow-up after 14 months). The aim is to prove the possible benefit of this online information tool for patients with level I evidence.

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Organizational Data

  •   DRKS00014627
  •   2018/06/12
  •   [---]*
  •   yes
  •   Approved
  •   EK 350082016, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

  •   U1111-1212-4087 
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   With 60,000 new diagnoses per year prostate cancer is the most common malignant disease in German men (Robert Koch Institute, 2016). There are various methods of treating prostate cancer, for example surgery, radiation, hormonotherapy or observation. Personal preferences and expectations also play an important role in the choice of the suitable treatment strategy. Some treatment methods can for example contain an increased risk of undesirable side effects. For this reason, the doctor and patient conduct an extensive personal consultation explaining the assets and drawbacks of various treatment options and detailed procedures. In order to give an overview of several treatment options to the patient mainly before the consultation with his urologist, information material is handed over, usually in the form of the " Patientenleitlinie/Patient Guideline" from the "Leitlinienprogramm Onkologie/ Guideline Program Oncology". The “PatientenAkademie” of “Deutsche Gesellschaft für Urologie e.V. / German Society of Urology” has developed an alternative to this leaflet since 2016, the so-called "Entscheidungshilfe Prostatakrebs/Decision Aid Prostate Cancer". This is an online information tool wherein the same content is explained in an interactive mode by using videos. In addition, the patient can enter all relevant information for the consultation in a standardized form. This is used to create a one-page summary that can serve as a basis for the following discussion.
    The trial “EvEnt-PCA” will now investigate, whether the new video-based decision tool can offer an additional benefit to the classic paper-based "Patient Guideline". In addition, the data collection and outcome of the study can provide important insights on the routine care for patients with prostate cancer in Germany. A total of 1,500 patients are to be included in the randomized study. Only male patients in the age group 18-80 with histologically confirmed adenocarcinoma of the prostate and no clinical evidence of metastases (cM0 or cMx) are considered. Further inclusion criteria are PSA < 100 ng/ml, no primary treatment, and no participation in other PCA studies. In addition, the decision making process must not be completed yet and the patient must have Internet access and an E-mail address.
    After the initial diagnosis, the attending physician offers study participation. After informed consent 750 patients are randomly assigned to use the Decision Aid Prostate Cancer (Intervention group: Usage of the Decision Aid Prostate Cancer) or they receive the printed brochure. For the study physicians, the work load includes two survey dates (study inclusion and follow-up after 14 months). On the patient side, three survey dates are planned (intervention and follow-up after one and 14 months).
  •   The approx. 100-page paper-based "Patient Guideline Prostate Cancer" is the current standard to inform patients after the diagnosis of prostate cancer. In contrast, the interactive patient-oriented decision aid, that is to be evaluated, provides relevant information on the disease and possible treatment options via video sequences to the patient. The effects of the decision aids are to be measured within the framework of the evaluation study described here. The randomization of a total of 1500 patients is carried out in two groups, whereby the use of the current "Patient Guideline Prostate Cancer" serves as a control group. The population of the study participants, the measuring times and the endpoints are corresponding to the intervention group. Patients in the control group receive the "Patient Guideline Prostate Cancer" in paper form after counseling by the physician. The follow-up documentation of the control group is paper-based and the documentation forms are sent by post. If the patient does not return the completed questionnaire, a data trustee will send back a maximum of two reminders every 3 weeks.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Treatment decision: stronger guideline conform use of deferred treatment startegies after 14 months. The treatment decision is recorded at the 14-month follow-up by the study physician using predefined categories (watchful waiting; active surveillance; radical prostatectomy; percutaneous radiation therapy; brachytherapy; others).

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Secondary Outcome

a) Knowledge: Knowledge Score (brief version) - measurement after use of intervention/control
b) Acceptance: Acceptability e-scale - measurement after use of intervention/control
c) Decision conflict: Decisional conflict scale (DCS) - measurement in follow-up after 1 month
d) Doctor-patient communication: Man Son Hing scale - measurement in follow-up after 1 month
e) Fear & Depressiveness: Patient Health Questionnaire-4 (PHQ-4) - Measurement after use of intervention/control and in follow-up after 1 and 14 months
f) regret of the treatment decision: Decision regret scale (DRS) - measurement in follow-up after 14 months
g) Quality of life: Expanded Prostate Cancer Index Composite (EPIC-26; 2 domains: incontinence and sexuality) - measurement in follow-up after 14 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2018/07/10
  •   1500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Histologically confirmed prostate adenocarcinoma, clinically not metastasized (cM0 or cMx), PSA < 100 ng/ml, age 18 - 80 years, internet access and e-mail address available

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Exclusion Criteria

Lack of consent or lack of agreement ability to participate in the study, completed decision making for primary treatment, previous primary treatment, participation in another study on prostate cancer

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Addresses

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    • Klinik und Poliklinik für Urologie
    • Mr.  PD Dr. med. Dr. phil.  Johannes  Huber 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Klinik und Poliklinik für Urologie
    • Mr.  PD Dr. med. Dr. phil.  Johannes  Huber 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • SMG Forschungsgesellschaft mbH
    • Ms.  Elke  Hempel 
    • Claire-Waldoff-Str. 3
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss (G-BA), Projektträger DLR
    • Mr.  Dr.  Jochen  Ziegelmann 
    • Wegelystr. 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.