Trial document




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  DRKS00010481

Trial Description

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Title

Feasibility of a Mind Body Medicine mobile app for cancer patients

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Trial Acronym

AIM-C

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URL of the Trial

http://www.iki.usz.ch/forschung/seiten/projekte.aspx

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Brief Summary in Lay Language

Project outline: Cancer is highly prevalent worldwide and its treatment causes high levels of distress. Standard medical care is often limited in addressing the psychological needs of cancer patients. Adjunct mind body medicine (MBM) therapies might overcome this gap by supporting the coping of cancer patients with physical and psychological symptoms. A shortcoming of MBM therapies is the limited access. Therefore, alternative delivery methods are required. Mobile apps represent such an alternative mode, but there is a substantial lack of scientific studies in this field.
Project aims: The aim of the study is to evaluate the feasibility of a MBM mobile app for cancer patients and investigating changes in mental health when using this application.
Methods: Cancer patients will receive a mobile app which includes three MBM exercises: mindfulness meditation, guided imagery, and progressive muscle relaxation. Patients will use the app for 20 weeks. We will use a mixed methods design
(questionnaires and focus group interviews) to evaluate the feasibility of the app.
Potential benefit for patients: A MBM app for cancer patients has the potential to increase patients’ mental health and has the advantage of being easily accessible to a large population. Our study will help in tailoring the
app towards the needs of cancer patients.

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Brief Summary in Scientific Language

Background: Cancer is highly prevalent. Getting diagnosed with cancer and cancer treatment itself can cause high levels of distress in patients. However, standard cancer treatment often neglects distress in cancer patients. Mind Body Medicine (MBM) interventions are suggested as adjunct interventions to reduce cancer related distress amongst others. However, access to face-to-face MBM interventions may be limited for some cancer patients. For instance, geographical distance, transportation problems, suffering from cancer-related illness, or limited mobility are barriers. A potentially cost-effective and easy accessible alternative as delivery method which is increasingly used for health interventions are mobile phone applications (apps)
Project aims: The aim of the study is to evaluate the feasibility of a MBM mobile app for cancer patients and investigating changes in quality of life when using this application. For this purpose we will evaluate the use, adherence, and implementation of a Mind Body Medicine based relaxation app in oncological settings.
Methods: We aim to recruit a total of 160 cancer patients. All participants will receive the MBM app for 20 weeks. The app contains three MBM exercises: mindfulness meditation, guided imagery, and progressive muscle relaxation exercises. The RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance) will be used to evaluate the app. For the evaluation we will use questionnaires and interview data as well as data collected via app. Health status and quality of life will be assessed with questionnaires at four time points. Interviews will be conducted after week 10.

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Organizational Data

  •   DRKS00010481
  •   2016/06/08
  •   [---]*
  •   yes
  •   Approved
  •   BASEC-Nr. 2016-00258, Kantonale Ethikkommission Zürich
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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

  •   All patients participating in the study will receive an app for the study duration of 20 weeks. The app consists of three relaxation exercises (mindfulness meditation, guided imagery, and progressive muscle relaxation) which are delivered through audio files (about 15 minutes each). We will recommend to carry out one of the three exercises at least five times per week on a different day.
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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

Health (PROMIS 29), time of assessment: Baseline, after week 4, 10, and 20
Quality of life (FACT-G), time of assessment: Baseline, after week 4, 10, and 20
Fear of Progression (PA-F-KF), time of assessment: Baseline, after week 10 and 20
Anxiety and Depression (HADS), time of assessment: Baseline, after week 10 and 20 Distress (Distress-Thermometer), time of assessment: Baseline, after week 10 and 20
Mindfulness (FFA), time of assessment: Baseline, after 4, 10 und 20 Wochen

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Secondary Outcome

n/a

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/07/28
  •   160
  •   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

- Male and female cancer patients
- Diagnosis of any solid cancer and stage of cancer
- Owner of either an iOS or Android based smartphone with at least weekly connection to the internet
- Additional inclusion criteria for setting 1: Attending a Mind Body Medicine treatment at the Institute for Complementary and Integrative Medicine, UniversityHospital Zurich

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Exclusion Criteria

- Suicidal ideation
- Insufficient German language skills
- Further reason which would prevent the participation in the study (e.g. move to a foreign country, insufficient knowledge on how to use a smartphone)

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Addresses

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    • Institut für komplementäre und integrative Medizin UniversitätsSpital Zürich
    • Mr.  PD Dr.  Jürgen  Barth 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    • Institut für komplementäre und integrative Medizin UniversitätsSpital Zürich
    • Ms.  Prof. Dr.  Claudia  Witt 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    • Institut für komplementäre und integrative Medizin UniversitätsSpital Zürich
    • Mr.  MSc  Michael  Mikolasek 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    • Institut für komplementäre und integrative Medizin UniversitätsSpital Zürich
    • Mr.  MSc  Michael  Mikolasek 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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Sources of Monetary or Material Support

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    • Krebsliga Schweiz
    • Effingerstrasse 40
    • 3008  Bern
    • Switzerland
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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.