Survey on chronic pain of longtime cancer survivors

Organizational Data

DRKS-ID:
DRKS00025282
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2021-05-27
Last update in DRKS:
2023-01-06
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

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

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.

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.

Health condition or problem studied

ICD10:
F45.41
ICD10:
R52.2 - Other chronic pain
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
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.

Endpoints

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.
Secondary outcome:
Satisfaction with previous treatment, pain intensity, duration of pain, pain localization

Study Design

Purpose:
Supportive care
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Cross-sectional study
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Interdisziplinäres Schmerzzentrum des UKF Freiburg im Breisgau

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2021-04-21
Planned study completion date:
No Entry
Actual Study Completion Date:
2021-07-25
Target Sample Size:
250
Final Sample Size:
33

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
History of tumor disease

Exclusion Criteria

Lack of language skills

Addresses

Primary Sponsor

Address:
Interdisziplinäres Schmerzzentrum
Dr. med. Kristin Kieselbach
Breisacher Str. 117
79106 Freiburg
Germany
Telephone:
+49-761-270-93490
Fax:
+49-761-270-54840
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/schmerzzentrum.html
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Interdisziplinäres Schmerzzentrum
Dr. med. Kristin Kieselbach
Breisacher Str. 117
79106 Freiburg
Germany
Telephone:
+49-761-270-93490
Fax:
+49-761-270-54840
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/schmerzzentrum.html

Contact for Public Queries

Address:
Interdisziplinäres Schmerzzentrum
Dr. med. Kristin Kieselbach
Breisacher Str. 117
79106 Freiburg
Germany
Telephone:
+49-761-270-93490
Fax:
+49-761-270-54840
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/schmerzzentrum.html

Principal Investigator

Address:
Interdisziplinäres Schmerzzentrum
Dr. med. Kristin Kieselbach
Breisacher Str. 117
79106 Freiburg
Germany
Telephone:
+49-761-270-93490
Fax:
+49-761-270-54840
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/schmerzzentrum.html

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Address:
Kirstins Weg · Verein zur Förderungder Krebsmedizin e. V., Kirstin Diehl-Stiftung
Theodor-Heuss-Straße 90
56564 Neuwied
Germany
Telephone:
+49-2631-53499
Fax:
+49-2631-958692
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.kirstins-weg.de/

Ethics Committee

Address Ethics Committee

Address:
Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2021-02-08
Ethics committee number:
21-1098
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-03-16

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Basically, the anonymized data from the survey are available to other Researchers on request.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry