Trial document




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  DRKS00005795

Trial Description

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Title

A lifestyle intervention program for patients with localized prostate cancer - a feasibility study

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Prostatectomies can be accompanied by severe side effects including erectile dysfunctions or incontinence. Active surveillance as a treatment options gains importance especially for patients with localized prostate cancer. A healthy lifestyle including physical activity, healthy nutrition and stress management can enhance the quality of life of patients and may be beneficial for prognosis. There are only limited concrete lifestlyle intervention options for these patients so far. The aim of the study is the assessment of the feasibility.

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Brief Summary in Scientific Language

Prostatectomies can be accompanied by severe side effects including erectile dysfunctions or incontinence. Active surveillance as a treatment options gains importance especially for patients with localized prostate cancer. A healthy lifestyle based on mind-body-medicine principles aas well as naturopathy/complementary and alternative medicien including physical activity, healthy nutrition and stress management can enhance the quality of life of patients and may be beneficial for prognosis. There are only limited concrete lifestlyle intervention options for these patients so far. The aim of the study is the assessment of the feasibility.

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Organizational Data

  •   DRKS00005795
  •   2014/02/19
  •   [---]*
  •   yes
  •   Approved
  •   14-5693-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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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

  •   lifestyle modification program (nutrition, physical exercise, relaxation, cognitve restructioning), 11 weeks, 6hrs/week

    + home-based exercises
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

compliance / adherence during intervention period (diary, attendance time)

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Secondary Outcome

questionnaires:
HRQoL (FACT-G, FACT-P)
anxiety (STAI)
depression (BDI)
mindfulness (FFA)
stress (PSS)
barriers
lifestly
coping (COPE)

Other:
saliva cortisol
pro- and anti-inflammatory cytonkines (plasma)

all post-intervention (11 weeks)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/03/03
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• PSA ≤ 10 ng/ml
• Gleason-Score ≤ 6
• cT1c and cT2a
• tumor in ≤ 2 punch biopsies (min. 8 punch biopsies )
• ≤ 50 % tumor / punch biopsy
• life expectancy min. 10 yrs
• Karnofsky-Index min. 80% or ECOG-Performance-Status 0-2
• written informed consent

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Exclusion Criteria

• previous or planned partial oder radical prostatectomy
• unsufficient knowledge of German language,
• severe physical or psychological diseases that may constrain patients
• systemic-neurological diseases (MS, parkinson, dementia).

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Addresses

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    • Universität Duisburg-Essen Lehrstuhl und Klinik für Naturheilkund und Integrative Medizin, Knappschafts-Krankenhaus, Kliniken Essen-Mitte
    • Mr.  Prof. Dr. med.  Gustav  Dobos 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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    • Universität Duisburg-Essen, Lehrstuhl und Klinik für Naturheilkunde und Integrative Medizin, Knappschafts-Krankenhaus, Kliniken Essen-Mitte
    • Mr.  Prof.  Gustav  Dobos 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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    • Universität Duisburg-Essen, Lehrstuhl und Klinik für Naturheilkunde und Integrative Medizin, Knappschafts-Krankenhaus, Kliniken Essen-Mitte
    • Mr.  Prof.   Gustav  Dobos 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Landeszentrum Gesundheit NRW
    • Gesundheitscampus-Süd 9
    • 44801  Bochum
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/10/04
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Trial Publications, Results and other Documents

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Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
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    • [---]*
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    •   [---]*
    •   [---]*
    •   [---]*
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  • Further contact 
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    • [---]*
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
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* This entry means the parameter is not applicable or has not been set.