ICanSelfCare Online Course for Learning Acupressure or Mindfulness for Cancer Patients with Fatigue or Sleep Problems
Zusammenfassung der Studie
Acupressure and mindfulness can be used to reduce fatigue and sleep problems in cancer patients. Together with cancer patients, doctors, and other experts, we have developed an online course that provides cancer patients access to scientifically based instructions to learn the application of acupressure or mindfulness in a standardized and independent manner. The aim of the study is to investigate the effectiveness of these digitally delivered self-care techniques (mindfulness or acupressure) on fatigue or sleep problems in people with cancer. Furthermore, it will be examined whether the preference for one of the two self-care techniques alters effectiveness. In our study, participants are assigned based on their main symptom of fatigue or sleep problems into one of two sub-studies. Each sub-study has three different groups: two experimental groups (acupressure or mindfulness) and one control group. Participants are randomly assigned to these three groups. A person in the experimental group begins immediately with the ICanSelfCare online course, regardless of their preference for a specific self-care technique. A person in the control group receives access to their preferred ICanSelfCare online course after a waiting period of 6 weeks. After weeks 3, 6, and 12 of the study, participants answer questions about their symptoms in an online questionnaire. Overall, participation in the study lasts 12 weeks. What is special about our study is that the study itself and all study activities (e.g., completing the online course, answering questionnaires) take place digitally. Informed consent to participate in the study is provided either in writing and sent by mail or electronically (eConsent). This means that cancer patients can participate in the study very flexibly and independently of time and place to learn a new skill.
(BASEC)
Untersuchte Intervention
The ICanSelfCare online course lasts 6 weeks. During the online course, participants receive a new module of the online course unlocked each week. In the first module of the online course, participants learn the self-care technique (acupressure or mindfulness). Completing the first module takes about 45 minutes. After that, another module (module 2 to module 6) is unlocked each week. In these modules, participants learn to apply the self-care technique in everyday life in the long term. Completing the subsequent modules takes about 10-15 minutes per module.
During the duration of the online course, we recommend that participants apply the learned self-care technique daily. The application of acupressure or mindfulness takes about 20-30 minutes per day.
(BASEC)
Untersuchte Krankheit(en)
Fatigue or sleep problems in cancer patients
(BASEC)
• At least 18 years old • Cancer newly diagnosed or recurrent within the last 5 years • Currently experiencing fatigue or sleep problems (BASEC)
Ausschlusskriterien
• Regularly receiving or practicing acupressure/acupuncture or mindfulness-based methods in the last three months, currently or planned within the next three months. An exception is if acupressure is applied exclusively at point P6 inside the wrist ("nausea acupressure point") for chemotherapy/radiotherapy-induced nausea. • Individuals with severe paranoid symptoms (e.g., delusions, hearing voices) (BASEC)
Studienstandort
Zürich, Andere
(BASEC)
Die eingeschlossenen Personen können aus allen Regionen der Schweiz kommen, da die Lernplattform unabhängig von der Lokalisation funktioniert.
(BASEC)
Sponsor
Prof. Dr. med. Claudia M. Witt, MBA Institute for Complementary and Integrative Medicine University Hospital Zurich (USZ) Sonneggstrasse 6 8091 Zurich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Claudia M. Witt
+41 44 255 23 96
claudia.witt@clutteruzh.chInstitute for Complementary and Integrative Medicine University Hospital Zurich (USZ) Sonneggstrasse 6 8091 Zurich
(BASEC)
Wissenschaftliche Auskünfte
Universittsspital Zrich
+41 44 255 24 60
claudia.witt@clutteruzh.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
06.09.2024
(BASEC)
ICTRP Studien-ID
DRKS00035596 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
eLearning of self-acupressure or a mindfulness technique for people with cancer to manage cancer related fatigue or sleep problems: randomized controlled trials (BASEC)
Wissenschaftlicher Titel
eLearning of self-acupressure or a mindfulness technique for people with cancer to manage sleep problems: randomized controlled trial - DITRAS-RCTs (ICTRP)
Öffentlicher Titel
eLearning of self-acupressure or a mindfulness technique for people with cancer to manage sleep problems: randomized controlled trial (ICTRP)
Untersuchte Krankheit(en)
C00-C97Malignant neoplasmsC00-C97 (ICTRP)
Untersuchte Intervention
Group 1: Acupressure (6 weeks eLearning)
Group 2: Mindfulness technique (6 weeks eLearning)
Group 3: Waitlist (6 weeks) (ICTRP)
Studientyp
interventional (ICTRP)
Studiendesign
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active//Other; Assignment: parallel; Study design purpose: treatment (ICTRP)
Ein-/Ausschlusskriterien
Inclusion criteria: cancer in the last five years (either first diagnoses or recurrence)
capability to apply self-care techniques
not confined to bed or chair more than 50% of waking hours ECOG Performance Status 0 to 2
Sleep problems with an intensity of at least 11 points on the Insomnia Severity Index (ISI)
good German language skills (ICTRP)
Exclusion criteria: acupuncture / acupressure treatment or practiced MBT on a regular basis during the last 3 months prior to our study intervention or if such is planned (outside of this study) within the next 3 months
symptoms of severe mental illness which are associated with symptoms of current paranoid delusion
Primäre und sekundäre Endpunkte
Sleep problems (Pittsburgh Sleep Quality Index PSQI after six weeks) (ICTRP)
Fatigue BFI (week 3, 6 and 12)
Health related Quality of Life (FACT G) (week 3, 6 and 12)
Distress (weekly during intervention)
Engagement in eLearning over 6 weeks
Adherence to self-care technique over 6 weeks (ICTRP)
Registrierungsdatum
05.12.2024 (ICTRP)
Einschluss des ersten Teilnehmers
03.02.2025 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Jrgen Barth, juergen.barth@usz.ch, +41 44 255 48 96, Universittsspital Zrich (ICTRP)
Sekundäre IDs
KFS-5723-02-2023 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
YesIndividual participant data that underlie the publications will be shared. This includes the code book, the statistical analysis plan and the code for analysis. The data will be shared after the acceptance of the publication (unlimited). Any researcher can use the data for free. (ICTRP)
Weitere Informationen zur Studie
http://drks.de/search/en/trial/DRKS00035596 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar