Trial document



drksid header

  DRKS00011868

Trial Description

start of 1:1-Block title

Title

Expectations and experiences of patients, experts and physicians with the term “immunotherapy” in cancer

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

Trial Acronym

SEEI

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

The term immunotherapy is a collective name for some Special cancer therapies. Currently immunotherapy is successfully used for the treatment of a few types of cancer for example advanced and metastatic Melanoma and NSCLC (non-small cell lung cancer). Therefore, there are several studies in which the effect of immune checkpoint inhibitors is being explored in other types of cancer.
Recent media reports and studies revealed promising results using/utilizing this form of therapy leading to expectations and hopes for both, patients and medical staff. Employees of the cancer information service and the National Centre for Tumour Diseases have to deal with these expectations every day. It is arguable, that the degree of patient information may have an influence on the therapy indications as well as extensive decisions with regard to an “off-label-use” of immunotherapy.
The main objective of the study is to investigate the expectations and experiences with immunotherapy from different points of view: cancer patients, patients who do not have cancer and physicians working with cancer patients.
Therefore, this therapy will be compared with conventional and established therapies and the participants will be questioned about both, immunotherapy and chemotherapy.
As this study is conceived as an exploratory study it is based on a mixed-methods design which combines quantitative and qualitative data collection and evaluation processes.
Within the quantitative and the qualitative part of the study, respectively, the study cohort will consist of several groups:
The quantitative part includes a total of 156 patients, subdivided into three groups: 52 patients who received immunotherapy, 52 patients who received chemotherapy and 52 patients who do not have cancer. This cohort will be asked on the basis of a questionnaire. Furthermore this patients should complete a short questionnaire on their own.
The cohort within the qualitative part contains 36 persons, consisting of 12 patients who received immunotherapy, 12 physicians who work in oncology and 12 staff members of the cancer information services, who will be interviewed. The interviews will be recorded, transcribed and analysed afterwards.

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

Brief Summary in Scientific Language

The term immunotherapy is a collective name for all cancer therapies which are based on a specific checkpoint blockade, in which antibodies are used to disrupt pathways that suppress T cell responses to tumours. Currently immunotherapy is successfully used for the treatment of a few types of cancer for example advanced and metastatic Melanoma and NSCLC (non-small cell lung cancer). Therefore, there are several studies in which the effect of immune checkpoint inhibitors is being explored in other types of cancer.
Recent media reports and studies revealed promising results using/utilizing this form of therapy leading to expectations and hopes for both, patients and (the) medical staff. Employees of the cancer information service and the National Centre for Tumour Diseases have to deal with these expectations every day. It is arguable, that the degree of patient information may have an influence on the therapy indications as well as extensive decisions with regard to an “off-label-use” of immunotherapy.
The main objective of the study is to investigate the expectations and experiences with immunotherapy from different points of view: cancer patients, patients who do not have cancer and physicians working with cancer patients.
Therefore, this therapy will be compared with conventional and established therapies and the participants will be questioned about both, immunotherapy and chemotherapy.
As this study is conceived as an exploratory study it is based on a mixed-methods design which combines quantitative and qualitative data collection and evaluation processes.
Within the quantitative and the qualitative part of the study, respectively, the study cohort will consist of several groups:
The quantitative part includes a total of 156 patients, subdivided into three groups: 52 patients who received immunotherapy, 52 patients who received chemotherapy and 52 patients who do not have cancer. This cohort will be asked on the basis of a questionnaire. Furthermore this patients should complete a short questionnaire on their own.
The cohort within the qualitative part contains 36 persons, consisting of 12 patients who received immunotherapy, 12 physicians who work in oncology and 12 staff members of the cancer information services, who will be interviewed. The interviews will be recorded, transcribed and analysed afterwards.

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

Organizational Data

  •   DRKS00011868
  •   2017/03/22
  •   [---]*
  •   yes
  •   Approved
  •   S-060/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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
  •   various cancers
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Interview and questionnaires with cancer patients undergoing immunotherapy regarding expectations and experiences with immunotherapy and chemotherapy.
  •   Interview and questionnaires with cancer patients undergoing chemotherapy regarding expectations and experiences with immunotherapy and chemotherapy.
  •   Interview and questionnaires with patients without cancer regarding expectations and experiences with immunotherapy and chemotherapy.
  •   Interview with physicians
  •   Interview with experts (staff members of cancer information Services)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

Assessement of expectations and experiencies of patients, experts and physicians concerning cancer immunotherapy and chemotherapy with interviews and questionnaires

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

Secondary Outcome

[---]*

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
  •   2017/03/29
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

General inclusion criteria for all members of the cohort:
•Age ≥ 18 Years
•Native German speaker or fluent German speaker
•Written declaration of consent

For patients who received immunotherapy:
•The patient is being treated with immunotherapy at the moment or was treated within the last year

For patients who received chemotherapy:
•The patient is being treated with chemotherapy at the moment or was treated within the last year
•The patient has no personal experience with immunotherapy

For patient who do not have cancer:
•The patients never had cancer
•Also their marriage partners, life partners and children never had cancer
•They do not work in a medical profession

For physicians:
•The exercise of their profession is connected to direct patient contact as well as cancer therapies. In the past they had talks with patients about immunotherapy and chemotherapy.

For staff members of cancer information services:
•They had to deal with patient inquiries regarding immunotherapy, and give information about this topic

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

Exclusion Criteria

•Limited capacity to contract
•Current cognitive reduction
•Serious psychiatric diseases or the existence of a somatization disorder, a general anxiety disorder or a serious depression
•Emotional stress
•Pregnancy

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Heidelberg
    • Mr.  Dr. med.  Imad  Maatouk 
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • 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
    • Sektion Psychoonkologie am Nationalen Centrum für Tumorerkrankungen
    • Mr.  Dr. med.  Imad  Maatouk 
    • INF 460
    • 69120  Heidelberg
    • 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
    • Sektion Psychoonkologie am Nationalen Centrum für Tumorerkrankungen
    • Mr.  Dr. sc. hum.  Andreas  Ihrig 
    • INF 410
    • 69120  Heidelberg
    • 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
    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • 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
  •   2018/07/13
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.