Trial document




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  DRKS00017500

Trial Description

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Title

Strengthening patient competency through cancer self-help: needs assessment and development of support services

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

A cancer diagnosis is associated with many burdens and challenges for those affected. In order to be able to cope with this situation, there are offers of professional support as well as organised cancer self-help. As part of the research project, cancer patients will be interviewed about their experiences and needs regarding organised cancer self-help in a needs analysis. On the basis of these interviews, an online questionnaire will be developed with which the need for support services of organised cancer self-help can be explored. In addition, a training programme will be developed and tested exemplarily in order to prepare former cancer patients for peer one-to-one support. After the training, the so-called patient coaches will offer non professional counselling for patients in an acute disease situations. The programme will be examined with regard to its implementation, acceptance and benefits.

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Brief Summary in Scientific Language

A cancer diagnosis is associated with many burdens and challenges for those affected. In order to be able to cope with this situation, there are offers of professional support as well as organised cancer self-help.
The research project consists of two subprojects:

Subproject I consists of a needs analysis in which cancer patients and self-help representatives are interviewed in the form of an epidemiological cross-sectional study on their experiences and needs with regard to organised cancer self-help. For this purpose, semi-structured interviews will be conducted (target sample size: 70). On the basis of these interviews, an online questionnaire will be developed (target sample size: 1,800).

Subproject II, to which the characteristics of the present register entry refer, examines to what extent a coaching programme for cancer survivors can contribute to supporting and strengthening the patient competence of cancer patients.

The study is a single-arm pilot study aiming to develop a training program for former cancer patients in order to support cancer patients in an earlier stage of cancer treatment. Due to the explorative character and the small case numbers, this study focuses on formative aspects of the evaluation. Thus, the study aims to examine mainly process and outcome characteristics of the preparatory event, the training program itself and the non-professional counselling sessions. Based on a mixed-method approach, a combination of interviews and questionnaire surveys will be used.

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

Yes

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Description IPD sharing plan:

The transfer of anonymised data upon request is generally possible and will be checked by the principal investigator.

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Organizational Data

  •   DRKS00017500
  •   2019/12/12
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  •   yes
  •   Approved
  •   359/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   Step 1: Developing a training for cancer survivors which prepares them for non-professional counseling of cancer patients in an earlier stage of cancer treatment. The training will be developed in cooperation with local cancer support groups. Therefore, members of local support groups will be interviewed who are either experienced in supporting and counseling cancer patients or could benefit from a non-professional counseling.
    Step 2: Holding a preparatory event to inform about the goals and the procedure of the training and to select suitable candidates for the following training program for non-professional patient counsellors.
    Step 3: Conducting the training in order to prepare selected former cancer patients for their role as a non-professional patient counsellor.
    Step 4: Evaluating the quality of the training by questioning the participants using a newly developed questionnaire immediately after the training.
    Step 5: Conducting a non-professional counselling session with cancer patients in local oncological centres. Depending on the needs of the supported patients, further counselling sessions can be conducted.
    Step 6: Evaluating the non-professional counselling sessions by questioning supported cancer patients as well as the non-professional patient counsellors using a newly developed questionnaire immediately after the counselling session.
    Step 7: By conducting regular personal supervision with the research team led by Prof. Weis, non-professional patient counsellors have the opportunity to reflect their experiences and feelings during the counselling sessions with the cancer patients, to address questions and concerns and to receive support and advise for following counselling sessions.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The study is a pilot scheme for developing a training program for former cancer patients in order to support cancer patients in an earlier stage of cancer treatment. Due to the explorative character and the small case numbers, this study focuses on formative aspects of the evaluation. Thus, this study aims to examine mainly process characteristics of the preparatory event, the training program itself and the non-professional counselling sessions. The questionnaires for the evaluation of the program are developed based on semi-structured interviews with representatives of local cancer support groups.

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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

  •   Planned
  •   2020/04/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Supported patients: Cancer patients in an earlier stage of cancer treatment in oncological centres.
2. Non-professional patient counsellors: former cancer patients who have already completed therapy and rehabilitation - with the exception of hormonal therapy. All non-professional patient counsellors went through a personal interview and participated in the training program.
3. Agreement to participate in the study
4. Age of consent
5. Good knowledge of the German language

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Exclusion Criteria

Excluded from the study are minors, potential participants with language barriers, severe cognitive impairments or severe mental illness that make a participation in the study impossible.

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Addresses

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    • Universitätsklinikum Freiburg Tumorzentrum - CCCF Stiftungsprofessur Selbsthilfeforschung
    • Mr.  Prof. Dr.  Joachim  Weis 
    • Hugstetterstr. 49
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Tumorzentrum Freiburg - CCCF Stiftungsprofessur Selbsthilfeforschung
    • Mr.  Prof. Dr.  Joachim  Weis 
    • Hugstetterstraße 49
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Tumorzentrum Freiburg - CCCF Stiftungsprofessur Selbsthilfeforschung
    • Ms.  Lena  Binkowski 
    • Hugstetterstraße 49
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Tumorzentrum Freiburg - CCCF Stiftungsprofessur Selbsthilfeforschung
    • Ms.  Theresa  Baadte 
    • Hugstetterstraße 49
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Gesellschaft zur Förderung von Wissenschaft, Forschung und Therapie auf dem Gebiet der Krebsmedizin e.V. (Fördergesellschaft Forschung Tumorbiologie e.V.)
    • Breisacherstraße 117
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.