ICanSelfCare Online Course for Learning Acupressure or Mindfulness for Cancer Patients with Fatigue or Sleep Problems
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
• 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)
Luogo dello studio
Zurigo, Altro
(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)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
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)
Informazioni scientifiche
Universittsspital Zrich
+41 44 255 24 60
claudia.witt@clutteruzh.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
06.09.2024
(BASEC)
ID di studio ICTRP
DRKS00035596 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
eLearning of self-acupressure or a mindfulness technique for people with cancer to manage cancer related fatigue or sleep problems: randomized controlled trials (BASEC)
Titolo accademico
eLearning of self-acupressure or a mindfulness technique for people with cancer to manage sleep problems: randomized controlled trial - DITRAS-RCTs (ICTRP)
Titolo pubblico
eLearning of self-acupressure or a mindfulness technique for people with cancer to manage sleep problems: randomized controlled trial (ICTRP)
Malattie studiate
C00-C97Malignant neoplasmsC00-C97 (ICTRP)
Intervento studiato
Group 1: Acupressure (6 weeks eLearning)
Group 2: Mindfulness technique (6 weeks eLearning)
Group 3: Waitlist (6 weeks) (ICTRP)
Tipo di studio
interventional (ICTRP)
Disegno dello studio
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active//Other; Assignment: parallel; Study design purpose: treatment (ICTRP)
Criteri di inclusione/esclusione
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
Endpoint primari e secondari
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)
Data di registrazione
05.12.2024 (ICTRP)
Inclusione del primo partecipante
03.02.2025 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Jrgen Barth, juergen.barth@usz.ch, +41 44 255 48 96, Universittsspital Zrich (ICTRP)
ID secondari
KFS-5723-02-2023 (ICTRP)
Risultati-Dati individuali dei partecipanti
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)
Ulteriori informazioni sullo studio
http://drks.de/search/en/trial/DRKS00035596 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile