Trial document




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  DRKS00010151

Trial Description

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Title

Developing a complementary medicine intervention tailored for cancer patients' healthcare needs to be addressed during follow-up care in general practice

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Trial Acronym

CAM-NAKOPA

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URL of the Trial

https://www.klinikum.uni-heidelberg.de/CAM-NAKOPA-Entwicklung-eines-hausaerztlichen-Beratungskonzeptes-fuer-den-Umgang-mit-komplementaerm.140813.0.html

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Brief Summary in Lay Language

The majority of cancer patients is interested in complementing their standard treatment and care with complementary and alternative medicine (CAM). Often these patients want to address these holistic healthcare needs within follow-up care taken place in the practice of their general practitioner (GP). Many GPs experience uncertainty in how to respond to patients' holistic healthcare needs and do not feel competent in advising certain CAM methods to their patients. For improving this healthcare structure, the current project aims to develop a CAM counselling intervention to be implemented in general practice. Based upon qualitative data gained from interviews and focus groups with GPs and their practice teams, patients, and CAM experts, an intervention focused on salutogenic counselling and evidence-based information delivery will be developed. This intervention will be piloted in general practices, so that it will then be ready to be tested in a confirmatory study design.

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Brief Summary in Scientific Language

Increasing numbers of oncology patients are interested in complementing their conventional medical treatment with complementary and alternative medicine (CAM), but often patients’ counseling needs are not met by their treating physicians. Patients have information needs with regard to self-management strategies, specific diet and exercise regimens, relaxation techniques, and complementary medicine methods. Supportive counseling programs addressing these needs are only fragmentary available and have not yet been integrated into the standard healthcare delivery in general practice. Studies indicate that general practitioners are interested in providing complementary and alternative medicine to their oncology patients, however, they often feel unsure and insufficient informed to counsel patients comprehensively.
Thus, the current project aims to develop a counseling CAM intervention for general practitioners, so that during follow-up care oncology patients can be individually informed in how they can complement their treatment with self-management activities and strategies involving CAM. Interviews with general practice teams, oncology patients, and CAM experts will be conducted in Heidelberg and Tübingen, Germany. Based on that qualitative data, a CAM counseling concept will be developed and piloted.

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Organizational Data

  •   DRKS00010151
  •   2016/03/23
  •   [---]*
  •   yes
  •   Approved
  •   S-664/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1180-9979 
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Health Condition or Problem studied

  •   C15-C26 -  Malignant neoplasms of digestive organs
  •   C50 -  Malignant neoplasm of breast
  •   C51-C58 -  Malignant neoplasms of female genital organs
  •   C60-C63 -  Malignant neoplasms of male genital organs
  •   C64-C68 -  Malignant neoplasms of urinary tract
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Interventions/Observational Groups

  •   Qualitative Data will be collected in three separate but intertwined studies:
    1) focus groups with approx. 20 general practice teams,
    2) interviews with approx. 20 oncology patients,
    3) interviews with approx. 10 CAM experts.
    Based upon the qualitative data analysis, the CAM counselling intervention will be composed and then piloted in approx. 5 general practices.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The aim of the CAM-NAKOPA-study is the development of a complementary counselling intervention to address holistic healthcare needs of oncology patients in general practice follow-up care.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/08/01
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

The following selection criteria will be applied for the purposeful sampling strategy:

General practitioners and their medical assistants: high/low interest in implementing a complementary counselling intervention in their general practices, high/low experience with oncology patients during follow-up care

Experts in complementary medicine: current stay as well as researching and teaching in German-speaking countries, member of national and international complementary medicine networks, managing directors or experts of/in national complementary medicine institutes or organizations

Patients: cancer diagnosis (gynecological, prostate, colorectal), completion of initial therapy, follow-up care in general practice, gender: female/male, employment status: employed/non-working, high/low interest in complementary medicine

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Exclusion Criteria

insufficient knowledge of the German language, cognitive disability

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Addresses

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    • Abteilung Allgemeinmedizin und VersorgungsforschungUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Joachim  Szecsenyi 
    • Im Neuenheimer Feld 130.3
    • 69120  Heidelberg
    • Germany
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    • Institut für Allgemeinmedizin und Interprofessionelle VersorgungUniversitätsklinikum Tübingen
    • Ms.  Prof. Dr.  Stefanie  Joos 
    • Österbergstr. 9
    • 72074  Tübingen
    • Germany
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    • Abteilung Allgemeinmedizin u. VersorgungsforschungUniversitätsklinikum Heidelberg
    • Ms.  Dr.  Nadja  Klafke 
    • Im Neuenheimer Feld 130.3, Turm West
    • 69120  Heidelberg
    • Germany
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    • Abteilung Allgemeinmedizin u. VersorgungsforschungUniversitätsklinikum Heidelberg
    • Ms.  Dr.  Nadja  Klafke 
    • Im Neuenheimer Feld 130.3, Turm West
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Nachwuchsakademie Versorgungsforschung Baden-Württemberg gefördert durch das baden-württembergische Ministerium für Wissenschaft, Forschung und Kunst in Zusammenarbeit mit dem Ministerium für Arbeit und Sozialordnung, Familie, Frauen und Senioren
    • Voßstr. 2
    • 69115  Stuttgart
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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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.