Trial document





This trial has been registered retrospectively.
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  DRKS00010774

Trial Description

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Title

Prostate Cancer Outcomes – Compare & Reduce Variation in Prostate Cancer Centers certified by the German Cancer Society

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Trial Acronym

PCO-D

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URL of the Trial

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Brief Summary in Lay Language

Prostate cancer is the most common cancer of men worldwide. Treatment-related side effects include urinary incontinence, bowel problems, erectile dysfunction and psychological discomfort. It is suspected that treatment results vary heavily across the world. Prostate cancer centers from 12 countries take part at the multinational PCO study (Prostate Cancer Outcomes - Compare & Reduce variation) to compare their results and to improve care. Currently, 23 of these centers are certified by the German Cancer Society that make up the centers of this (German-speaking) sub-study. Other participating centers are located in Australia, the USA, Italy and the United Kingdom, to mention only a few countries. The participating centers systematically record clinical and patient reported outcomes (PROs) for localized prostate cancer and compare results across sites.

Expected results include statements regarding the quality of care in prostate cancer centers taking into account the patient's perspective, the recognition of regional / hospital-related differences and the identification of measures to improve quality in centers.

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Brief Summary in Scientific Language

Background: The assessment of health outcomes quality beyond survival rates is of particular impor-tance with regard to prostate cancer, as the four most commonly applied treatment strategies (radical prostatectomy, percutaneous radiotherapy, LDR or HDR brachytherapy, active surveillance) each have specific side-effect patterns, which significantly co-vary with provider and patient/disease char-acteristics. In the past, numerous observational studies have investigated the advantages and disad-vantages of different strategies in terms of survival and major physical side-effects such as inconti-nence, erectile dysfunction and bowel problems, as well as differences between clinicians. Possible psychological and social effects, such as fear of progression/recurrence of the disease or reduced participation in public life, in addition to the physical consequences of treatments are contributing to the complexity of health outcome assessments.
Objectives of the study: The primary objective of the study is to compare the quality of health out-comes (patient-reported and clinical) in participating prostate cancer centres that have been certified according to the requirements of the German Cancer Society with each other and - in the second step - with international centres. The secondary objective of the study is the analysis of selected (and, in this form, new) methods for identifying potential pitfalls in patient inclusion and representation, in the user-friendliness of the survey tool as well as in data linking (formative evaluation of methods).
Methods: In this multicentric observational study with consecutive full survey of the study population, patients with localised prostate cancer are interviewed at baseline and then periodically following therapy (follow-up to 10 years) using standardised tools. The survey data will be linked to clinical features gathered by the centres. Additionally characteristics of the centres are recorded. Statistical analysis is performed using the common descriptive and (multilevel) regression analysis methods. Health outcomes are compared case-mix-adjusted.
Anticipated results: Statements about the quality of care in prostate cancer centres taking into account the patient's perspective and where applicable regional/hospital-related differences. Measures to improve quality in certified centres will be taken based on the results of the study. It is anticipated that the differences in the quality of health outcomes will decrease over time as measures are introduced in less high-quality centres. Possibilities for the identification of individual measures to improve poor quality of life shall additionally be highlighted.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010774
  •   2016/09/08
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  •   yes
  •   Approved
  •   Eth-12/16, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Prostate cancer patients are surveyed pre- and posttherapeutically (EPIC-26 and additional items) to identify differences in outcomes across centers. Additional clinical parameters are collected according to study protocol
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1. (relative) survival, 2. disease-free survival, 3. PROs: 3a. incontinence, 3b. irritative/obstructive, 3c. gastrointestinal, 3d. sexuality, 3e. hormonal, and 3f. libido, collected after 6 and 12 months, then annually

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Secondary Outcome

formative evaluation of data collection method

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

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

  •   Actual
  •   2016/07/01
  •   40000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Patients with localized prostate cancer

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Exclusion Criteria

insufficient language skills to fill out questionnaire

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Addresses

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    • Deutsche Krebsgesellschaft
    • 14059  Berlin
    • Germany
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    • OnkoZert
    • Gartenstraße 24
    • 89231  Neu-Ulm
    • Germany
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    • Bundesverband Prostatakrebs Selbsthilfe
    • 53111 
    • Germany
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    • Deutsche Krebsgesellschaft
    • Mr.  Dr.  Christoph  Kowalski 
    • Kuno-Fischer-Str. 8
    • 14059  Berlin
    • Germany
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    • Deutsche Krebsgesellschaft
    • Mr.  Dr.  Christoph  Kowalski 
    • Kuno-Fischer-Str. 8
    • 14059  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Movember Foundation
    • 8002  East Melbourne
    • Australia
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Ethikvotum PCO
  •   Studienprotokoll PCO
  •   Studienprotokoll Englisch
  •   Studienprotokoll Deutsch_Amendment 2018
  •   Sibert NT, Dieng S, Oesterle A, Feick G, Carl G, Steiner T, Minner J, Roghmann F, Kaftan B, Zengerling F, Hinkel A, Beyer B, Heidenreich A, Harke N, Brehmer B, Pfitzenmaier J, Fichtner J, Neisius A, Hammerer P, Wesselmann S, Kowalski C (2019). Psychometric validation of the German version of the EPIC‑26 questionnaire for patients with localized and locally advanced prostate cancer. World Journal of Urology. DOI: 10.1007/s00345-019-02949-7.
  •   Roth R, Dieng S, Oesterle A, Feick G, Carl G, Hinkel A, Steiner T, Kaftan B, Kunath F, Hadaschik B, Oostdam SJ, Palisaar RJ, Koralewski M, Beyer B, Wesselmann S, Kowalski C (2020). Determinants of self-reported functional status (EPIC-26) in prostate cancer patients prior to treatment. World Journal of Urology. DOI: 10.1007/s00345-020-03097-z
  •   Breidenbach C, Roth R, Ansmann L, Wesselmann S, Dieng S, Carl EG, Feick G, Oesterle A, Bach P, Beyer B, Borowitz R, Erdmann J, Kunath F, Oostdam SJ, Tsaur I, Zengerling F, Kowalski C. (2020). Use of psycho‐oncological services by prostate cancer patients: A multilevel analysis. Cancer Medicine. DOI: 10.1002/cam4.2999.
  •   Kowalski C, Roth R, Carl G, Feick G, Oesterle A, Hinkel A, Steiner T, Brock M, Kaftan B, Borowitz R, Zantl N, Heidenreich A, Neisius A, Darr C, Bolenz C, Beyer B, Pfitzenmaier J, Brehmer B, Fichtner J, Haben B, Wesselmann S, Dieng S. (2020). A multicenter paper-based and web-based system for collecting patient-reported outcome measures in patients undergoing local treatment for prostate cancer: first experiences. Journal of Patient-Reported Outcomes 4(56). DOI: 10.1186/s41687-020-00224-7.
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* This entry means the parameter is not applicable or has not been set.