Trial document




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  DRKS00025282

Trial Description

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Title

Survey on chronic pain of longtime cancer survivors

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Trial Acronym

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URL of the Trial

https://www.uniklinik-freiburg.de/schmerzzentrum/forschung-und-kooperationen.html

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Brief Summary in Lay Language

More and more people are surviving cancer in the long term. Chronic pain in long-term survivors after cancer or oncologic therapies, however, is a problem that has been often neglected up to now.
In order to provide more clarity about the content and procedures in the treatment of chronic cancer pain, the aim of this study is to investigate which pain treatment programs can be used by long-term survivors in the case of persistent cancer-related pain. In order to be able to develop appropriate programs, more information is needed from those people who suffer from such chronic pain. For this reason, a survey on demographics and tumor diseases, on the pain and on previous and desired treatments is carried out using an internet-based, anonymized questionnaire.

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Brief Summary in Scientific Language

The prevalence of chronic pain in Germany ranges around appr. 28%. Chronic pain can have non-tumor-related as well as tumor-related causes and, depending on the degree of chronification, can be viewed as an independent pain disorder with bio-psycho-social causes. In addition to individual physical and psychological impairments, they lead to a health economical burden with high care costs. A significant increase in chronic pain disorders is forecast for the next few decades. Comprehensive and sustainable treatment of patients with chronic pain is therefore urgently required. The interdisciplinary multimodal pain therapy represents an effective team-based treatment of chronic pain syndromes. The aim is to treat the various causes of chronic pain in all dimensions and to improve both disease understanding and functionality.
At least 30% of tumor patients report severe pain in connection with their disease. Now >50% of cancer patients have a survival time of 10 years ore more. In these long-term surviving tumor patients, there is a prevalence of 20-40% for chronic pain. The chronification factors in chronic tumor pain include tumor- and therapy-related causes, hypersensitization mechanisms and psychosocial risk factors, analogous to patients with non-tumor-related pain. The increasing number of patients with chronic cancer pain indicates that this group of patients is inadequately supported in terms of pain therapy. Tumor-specific, multimodal pain-specific diagnostics and therapy could, as in the area of ​​non-tumor-related pain therapy, lead to improvements in the care of long-term surviving cancer patients with chronic pain.
In the first step, long-term cancer patients suffering from chronic pain should be asked about their pain disorder. For a more precise needs analysis, information on demographics and tumor disease, pain and previous and desired treatments should be collected. For this purpose, an anonymized survey is carried out, which is posted on the websites of tumor self-help groups or the websites for long-term surviving tumor patients.

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

Yes

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Description IPD sharing plan:

Basically, the anonymized data from the survey are available to other Researchers on request.

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Organizational Data

  •   DRKS00025282
  •   2021/05/27
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  •   yes
  •   Approved
  •   21-1098, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
  •   R52.2 -  Other chronic pain
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Interventions/Observational Groups

  •   Internet-based, anonymized patient survey over three months (June - Aug 2021) on the websites of tumor self-help groups or the websites for long-term surviving tumor patients. Long-term surviving cancer patients will be asked about their chronic pain disorder. For a more precise needs analysis, information on demographics and tumor disease, pain and previous and desired treatments should be collected.

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Characteristics

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

Severity of pain and satisfaction with previous treatment. Objective: Need for treatment for chronic pain as a result of / after tumor diseases.
Exploratorative, purely descriptive analysis to describe the sample. Calculation of the mean values ​​/ variance of the individual measurement parameters with, if necessary, subgroup analyzes.

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Secondary Outcome

Satisfaction with previous treatment, pain intensity, duration of pain, pain localization

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/05/02
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

History of tumor disease

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Exclusion Criteria

Lack of language skills

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Interdisziplinäres Schmerzzentrum
    • Ms.  Dr. med.  Kristin  Kieselbach 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
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    • Interdisziplinäres Schmerzzentrum
    • Ms.  Dr. med.  Kristin  Kieselbach 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
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    • Interdisziplinäres Schmerzzentrum
    • Ms.  Dr. med.  Kristin  Kieselbach 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Kirstins Weg · Verein zur Förderungder Krebsmedizin e. V., Kirstin Diehl-Stiftung
    • Mr.  Gerd-Peter  Diehl 
    • Theodor-Heuss-Straße 90
    • 56564  Neuwied
    • 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.