EFFECTIVENESS OF A MINDFULNESS AND RELAXATION SELF-CARE APP ON CANCER PATIENTS’ DISTRESS: A RANDOMIZED CONTROLLED STUDY
Organizational Data
- DRKS-ID:
- DRKS00027546
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-02-23
- Last update in DRKS:
- 2023-11-20
- Registration type:
- Prospective
Acronym/abbreviation of the study
CanRelax
URL of the study
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.
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).
Health condition or problem studied
- ICD10:
- C00-C97 - Malignant neoplasms
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Intervention group (CanRelax app intervention to reduce distress)
- Arm 2:
- Control group 1 (waiting list, randomized) after 10 weeks of waiting period
- Arm 3:
- Control group 2 (low distress levels, not randomized with CanRelax app)
Endpoints
- Primary outcome:
- Distress after 10 weeks (PHQ-ADS)
- 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
Study Design
- Purpose:
- Supportive care
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Switzerland
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center online Zürich
Recruitment period and number of participants
- Planned study start date:
- 2022-07-20
- Actual study start date:
- 2022-07-20
- Planned study completion date:
- 2023-09-30
- Actual Study Completion Date:
- 2023-09-30
- Target Sample Size:
- 210
- Final Sample Size:
- 210
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- 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.
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)
Addresses
Primary Sponsor
- Address:
- Institut für komplementäre und integrative Medizin UniversitätsSpital ZürichPD Dr. Jürgen BarthSonneggstrasse 68091 ZürichSwitzerland
- Telephone:
- +41 (0)44 255 48 96
- Fax:
- +41 (0)44 255 43 94
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.iki.usz.ch
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für komplementäre und integrative Medizin UniversitätsSpital ZürichPD Dr. Jürgen BarthSonneggstrasse 68091 ZürichSwitzerland
- Telephone:
- +41 (0)44 255 48 96
- Fax:
- +41 (0)44 255 43 94
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.iki.usz.ch
Contact for Public Queries
- Address:
- Institut für komplementäre und integrative Medizin UniversitätsSpital ZürichPD Dr. Jürgen BarthSonneggstrasse 68091 ZürichSwitzerland
- Telephone:
- +41 (0)44 255 48 96
- Fax:
- +41 (0)44 255 43 94
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.iki.usz.ch
Principal Investigator
- Address:
- Institut für komplementäre und integrative Medizin UniversitätsSpital ZürichPD Dr. Jürgen BarthSonneggstrasse 68091 ZürichSwitzerland
- Telephone:
- +41 (0)44 255 48 96
- Fax:
- +41 (0)44 255 43 94
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.iki.usz.ch
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Swiss Cancer ResearchEffingerstrasse 403001 BernSwitzerland
- Telephone:
- +41313899300
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Kantonale Ethikkommission ZürichStampfenbachstrasse 1218090 ZürichGermany
- Telephone:
- (+41)43-2597970
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-05-12
- Ethics committee number:
- 2021-01071
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-09-03
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry