Trial document




drksid header

  DRKS00011589

Trial Description

start of 1:1-Block title

Title

Financial impact of cancer diseases and the resulting psychosocial burden. A qualitative study from the patient´s point of view

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

Trial Acronym

KMA

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

URL of the Trial

http://ims.uni-halle.de/forschung/forschungsprojekte/laufende_projekte/kma/

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

Brief Summary in Lay Language

International studies show major consequences of being diagnosed with cancer on the financial situation. Nevertheless, the psychosocial stress resulting from the financial burden is less investigated.

The aim of this qualitative study is to examine the financial hardship of cancer and potentially psychosocial burden from the patient’s point of view.

Therefore 30 patients, aged at least 30 years, with colorectal-, lung-, breast- or prostate cancer will be included in the study. Patients will be asked verbatim using semistructured guided interviews about their experiences. Acute treatment of cancer should have been completed at least five years prior.

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

Brief Summary in Scientific Language

The number of patients suffering from cancer is constantly rising. Cancer is associated with physical and psychological stress but also with financial burden. The financial hardship of cancer is receiving more and more attention in international research in recent years. Nevertheless the psychosocial stress resulting from the financial burden has not been investigated so far.

The aim of this qualitative study is to examine the financial hardship of cancer and potentially psychosocial burden from the patient’s point of view.

Therefore 30 patients, aged at least 30 years, with colorectal-, lung-, breast- or prostate cancer will be included in the study. Patients will be asked verbatim using semistructured guided interviews about their experiences. Acute treatment of cancer should have been completed at least five years prior. Recruitment is carried out at Krukenberg Cancer Center, oncological clinics, general practitioners, self-help groups, cancer information centers.

The patients will be asked face to face using semi-structured guided interviews. The data will be analyzed in accordance with Glaser and Strauss´s rules of Grounded Theory. MAXQDA software will be used to analyze data.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011589
  •   2017/01/27
  •   [---]*
  •   yes
  •   Approved
  •   2016-126, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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

  •   C18 -  Malignant neoplasm of colon
  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C50 -  Malignant neoplasm of breast
  •   C61 -  Malignant neoplasm of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   30 patients with a first colorectal-, lung-, breast or prostate cancer, aged at least 30 years, after completed acute treatment and maximum five years later, are recruited consecutively over a period of 10 month. The patients will be asked face-to-face using semi-structured interviews. Additionally demographics and quality of life will be explored using standardized questionnaires.
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
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Using semi-structured guided interviews the medical history, the financial situation before and after cancer diagnosis, psychosocial stress and resources reducing the financial burden is measured.

The aim is to answer the following research questions:
1.What impact does cancer have on the financial situation of patients and their relatives in Germany?
2. Which psychosocial effect does the financial burden have on the quality of live and subjective health of patients?
3.Can social risk groups be identified which are more vulnerable to financial burden of cancer?
4.What factors influence financial burden most strongly and which personal and social factors can help to reduce or increase financial hardship?

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

Secondary Outcome

For the purpose of measuring sociodemographic data, socioeconomic status and quality of life (SF-12) an short standardized questionnaire will be used.

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

  • Doctor's Practice 
  • other 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/05/08
  •   30
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

- Patients aged 30 and over
- with a first cancer disease (colorectal cancer, lung cancer, breast cancer, prostate cancer)
- acute treatment has been completed maximum five years ago

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

Exclusion Criteria

- Patients with insufficient language skills to conduct an interview in German
- moribund patients

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Medizinische SoziologieMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg
    • Mr.  Prof. Dr.  Matthias  Richter 
    • Magdeburger Str. 8
    • 06112  Halle
    • 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 other
    • Heinrich-Heine-Universität DüsseldorfInstitut für Medizinische Soziologie
    • Mr.  Prof. Dr.  Nico  Dragano 
    • Universitätsstraße 1
    • 40225  Düsseldorf
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Deutsche Krebsgesellschaft e. V.
    • Mr.  Dr.  Christoph  Kowalski 
    • Kuno-Fischer-Str. 8
    • 14057  Berlin
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Institut für Medizinische SoziologieMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg
    • Ms.  Sara  Schröder 
    • Magdeburger Str. 8
    • 06112  Halle
    • 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
    • Institut für Medizinische SoziologieMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg
    • Ms.  Sara  Schröder 
    • Magdeburger Str. 8
    • 06112  Halle
    • 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
    • Stiftung Deutsche Krebshilfe
    • Buschstr. 32
    • 53113  Bonn
    • 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 complete, follow-up complete
  •   2018/04/24
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.