Trial document



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  DRKS00011868

Trial Description

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Title

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

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Trial Acronym

SEEI

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URL of the Trial

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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.

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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.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011868
  •   2017/03/22
  •   [---]*
  •   yes
  •   Approved
  •   S-060/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
  •   various cancers
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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)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/03/29
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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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

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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

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Addresses

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    • Universitätsklinikum Heidelberg
    • Mr.  Dr. med.  Imad  Maatouk 
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Sektion Psychoonkologie am Nationalen Centrum für Tumorerkrankungen
    • Mr.  Dr. med.  Imad  Maatouk 
    • INF 460
    • 69120  Heidelberg
    • Germany
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    • Sektion Psychoonkologie am Nationalen Centrum für Tumorerkrankungen
    • Mr.  Dr. sc. hum.  Andreas  Ihrig 
    • INF 410
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2018/07/13
  •   200
  •   200
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Trial Publications, Results and other Documents

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