Trial document




drksid header

  DRKS00015516

Trial Description

start of 1:1-Block title

Title

Prospective formative and summative evaluation of the counseling and intervention services of the Cancer Counseling Centers Eppendorf and Harburg of the Hamburg Cancer Society e.V

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

Trial Acronym

HKG EVA

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

URL of the Trial

http://www.uke.de/hkg-eva

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

Brief Summary in Lay Language

Many cancer patients not only have to deal with problems caused by their illness, but also with mental stressors. The Cancer Counseling Centers provide a variety of psychosocial support offers. In order to be able to continuously improve the care of cancer patients, we are interested in the experiences they have had in the context of their illness with psychosocial support offers. We are also interested in possible barriers for seeking help. The Institute and Polyclinic for Medical Psychology of the University Medical Center Hamburg-Eppendorf will therefore conduct a study. The purpose of this study is to identify helpful or hindering issues related to access the services in order to counter potential barriers in the future, thereby improving the care of cancer patients and their relatives.

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

Brief Summary in Scientific Language

The study is aimed at optimizing the psychosocial care of cancer patients and their relatives in Hamburg through the Cancer Counseling Services of the Hamburger Krebsgesellschaft e.V.
The requirements, the sustainability as well as the satisfaction with the counseling and intervention offers in the two counseling centers of the Hamburger Krebsgegesellschaft e.V. are analyzed. Furthermore, possible changes of distress and health-related quality of life as well as other psychosocial variables (anxiety, depression, satisfaction, concerns etc. of the participants) will be investigated before and after having taken advantage of an counseling session (psychoeducational courses, artistic therapies, information events, etc.). They will be compared with a non-randomized control group. In addition, with the help of the control group, barriers to the use of the sevices, as well as unmet needs for support, should be identified in order to be able to optimize the offers in both counseling centers.

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

Organizational Data

  •   DRKS00015516
  •   2018/10/16
  •   [---]*
  •   yes
  •   Approved
  •   LPEK-007, Lokale Psychologische Ethikkommission am Zentrum für Psychosoziale Medizin (LPEK)
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

  •   C00-C97 -  Malignant neoplasms
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Cancer patients or their relatives who are seeking one or more counseling sessions at one of the two Hamburg Cancer Counseling Centers.

    Participants will receive the baseline questionnaire in the counseling center before the first consultation, a post-questionnaire by post two weeks after the consultation, as well as the follow-up questionnaire 3 months after the consultation also by mail.
    The questionnaires consist of questions on sociodemographic questions, standardized scales (distress thermometer, SF-8, EORTC-QLQ-C30, WHO-5, Self-Mastery Scale, PHQ9, GAD-7, Fatigue Assessment Scale) as well as questionnaires for the evaluation of and satisfaction (ZUF-8) with the counseling sessions and the counselor.
  •   Cancer patients who have had no contact with counseling centers and visit outpatients oncologists.
    They receive the baseline questionnaire on site and the follow-up questionnaire 3 months later by mail.
    The questionnaires consist of questions on sociodemographic questions, standardized scales (distress thermometer, SF-8, EROTC-QLQ-C30, WHO-5, Self-Mastery Scale, PHQ9, GAD-7, Fatigue Assessment Scale) and questions about possible barriers to not using cancer counseling.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Distress (distress thermometer) at measurement points T0 (baseline, T1 (after two weeks) and T2 (after 3 months).

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

Secondary Outcome

Quality of Life (SF-8, EORTC-QLQ C30)
Self mastery / personal control (Self mastery scale by Pearlin and Schooler),
Well-being (WHO-5)
at the measuring points T0, T1 and T2.
Also:
Depression (PHQ-9)
Anxiety (GAD-7)
Fatigue (FAS)
Satisfaction (ZUF-8),
Consultant-Patient Relationship (HAQ)
at the measuring points T1 and T2

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

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/12/05
  •   787
  •   Multicenter 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

Cancer diagnosis or relative of a cancer patient

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

Exclusion Criteria

Insufficient knowledge of the German language, severe physical and cognitive limitations.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut und Poliklinik für medizinische Psychologie, Universitätsklinikum Eppendorf
    • Mr.  Prof. Dr.  Holger  Schulz 
    • Martinistraße 52
    • 20246  Hamburg
    • 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
    • Hamburger Krebsgesellschaft e.V
    • Butenfeld 18
    • 22529  Hamburg
    • 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 und Poliklinik für medizinische Psychologie, Universitätsklinikum Eppendorf
    • Ms.  M.Sc.  Solveigh  Lingens 
    • Martinistraße 52
    • 20246  Hamburg
    • 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 und Poliklinik für medizinische Psychologie, Universitätsklinikum Eppendorf
    • Ms.  M.Sc.  Solveigh  Lingens 
    • Martinistraße 52
    • 20246  Hamburg
    • 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
    • Hamburger Krebsgesellschaft e.V
    • Butenfeld 18
    • 22529  Hamburg
    • 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.