Trial document



drksid header

  DRKS00025282

Trial Description

start of 1:1-Block title

Title

Survey on chronic pain of longtime cancer survivors

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

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

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

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

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00025282
  •   2021/05/27
  •   [---]*
  •   yes
  •   Approved
  •   21-1098, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
  •   R52.2 -  Other chronic pain
end of 1:N-Block indications
start of 1:N-Block interventions

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.

end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2021/05/02
  •   250
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

History of tumor disease

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Lack of language skills

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Interdisziplinäres Schmerzzentrum
    • Ms.  Dr. med.  Kristin  Kieselbach 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Interdisziplinäres Schmerzzentrum
    • Ms.  Dr. med.  Kristin  Kieselbach 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Interdisziplinäres Schmerzzentrum
    • Ms.  Dr. med.  Kristin  Kieselbach 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Kirstins Weg · Verein zur Förderungder Krebsmedizin e. V., Kirstin Diehl-Stiftung
    • Mr.  Gerd-Peter  Diehl 
    • Theodor-Heuss-Straße 90
    • 56564  Neuwied
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.