Trial document




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  DRKS00027546

Trial Description

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Title

EFFECTIVENESS OF A MINDFULNESS AND RELAXATION SELF-CARE APP ON CANCER PATIENTS’ DISTRESS: A RANDOMIZED CONTROLLED STUDY

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Trial Acronym

CanRelax

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URL of the Trial

http://www.canrelax.org

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Brief Summary in Lay Language

We are investigating the effectiveness of a mindfulness and relaxation app (CanRelax App) in a research project All participating individuals will be given access to the app, with one subgroup starting immediately and the other only being able to fully use the app after a waiting period of 10 weeks. Random assignment into one of the two study groups meets the criteria of a randomised controlled intervention study. The app offers various audio files with guided mindfulness and relaxation exercises that participants can perform independently at a time of their choosing. Accompanying this, they are motivated by a chatbot to do relaxation exercises on a regular basis. The participants receive information on the exercises and are continuously supported in setting goals and implementing them in their daily lives.

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Brief Summary in Scientific Language

The aim is to evaluate the effectiveness of the CanRelax app in reducing distress in cancer patients, compared to patients in a waiting list group who have no access to the intervention.
Secondary objectives are the evaluation of well-being, self-regulation and the course of distress over time. We will also evaluate the adherence to the app and the relaxation response to specific relaxation exercises.
In addition to that we will explore if patients with initial low distress continuously use the app (i.e. adherence) and if they can remain on low distress during follow-up (control group 2).

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00027546
  •   2022/02/23
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  •   yes
  •   Approved
  •   2021-01071, 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

  •   Intervention group (CanRelax app intervention to reduce distress)
  •   Control group 1 (waiting list, randomized) after 10 weeks of waiting period
  •   Control group 2 (low distress levels, not randomized with CanRelax app)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Distress after 10 weeks (PHQ-ADS)

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Secondary Outcome

Secondary endpoints:
- Bi-weekly assessed distress (PHQ-4 and Distress Thermometer)
- Well-Being Index (WHO-5)
- Self-regulation (MAIA subscale)
- Mind Body Medicine scale (MBM scale)

Further endpoints:
- Adherence to the app intervention (i.e. practicing exercises)
- Relaxation response for specific relaxation exercises

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Countries of Recruitment

  •   Switzerland
  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2022/07/20
  •   210
  •   Monocenter trial
  •   International
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Inclusion Criteria

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

Patients, who have (had) a cancer diagnosis (first or relapse) within the last 5 years independent of type and stage, show an elevated level of distress (min. score of 5 on Distress Thermometer).


Patients with a lower score will be directly transferred to the start of the intervention without randomization (control group 2) if they meet all other eligibility criteria.

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Exclusion Criteria

Patients, who report suicidal ideation, have insufficient German language skills, pregnant according to self-report (known pregnancy), show further reason which would prevent participation in the study (e.g. 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
    • Mr.  PD Dr.  Jürgen  Barth 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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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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Sources of Monetary or Material Support

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    • Swiss Cancer Research
    • Effingerstrasse 40
    • 3001  Bern
    • Switzerland
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    •   +41313899300
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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