Clinical trial NCT06248450: Medical YOga dUring CANcer Treatment in a Digital or Physical Setting - a PREFERensbased Study
Official title: Medical Yoga During Cancer Treatment in a Digital or Physical Setting - a Preference-based Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: oncological treatment
yoga
e-health
rehabilitation
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Linkoeping
name: Ryhov County Hospital
First posted: 2024-02-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Preference-based allociation to group yoga in a physical or in a digital setting
Primary purpose: SUPPORTIVE_CARE

Brief summary: To enhance the implementation of yoga in cancer care, studies that explore patients with cancer preferences for the execution of yoga, effects, and the experience of participating in group yoga sessions online compared to in-person sessions is required. The aim of the YouCanPrefer-study is to explore preferences, expectations, implementation, experiences, and effects of participating in in-person group yoga sessions at a yoga studio compared to participating in online-yoga at home for patients with cancer undergoing oncological treatment. Additionally, the aim is to study health-related outcomes of yoga. Patients diagnosed with cancer undergoing oncological treatment at two hospitals in Sweden will be included in the study. A preference-based allocation will be used, participants chose self if they want to participate in in-person yoga at a studio or in yoga online. Regardless of allocation, the yoga sessions will take place in a group setting once a week for a duration of 12 weeks. All participants will also have access to a yoga application on their tablets or cell phones, with a recommendation to engage in self-guided yoga for at least 10 minutes per day.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cancer and scheduled for or initiated oncological treatment at an oncology clinic.
* Received written information about the study.
* Willing to participate in the study and able to follow the protocol.
* Understanding and expressing themselves in Swedish.
* Age ≥ 18 years.
* Provided informed consent.

Exclusion Criteria:

* Patients with severe cognitive impairments such as dementia and serious psychiatric illness.
* Patients with significant physical disabilities that may hinder yoga.
* Patients with difficulties completing questionnaires.
* Expected survival of less than 3 months.

Primary outcomes:
measure: Patients preferences to yoga during oncological treatment
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Baseline, 3 months and 6 months
measure: Health
timeFrame: Baseline, 3 months and 6 months
measure: Anxiety and depression
timeFrame: Baseline, 3 months and 6 months
measure: Fatigue
timeFrame: Baseline, 3 months and 6 months
measure: Sleep
timeFrame: Baseline, 3 months and 6 months
measure: Stress
timeFrame: Baseline, 3 months and 6 months
measure: Physical Activity
timeFrame: Baseline, 3 months and 6 months
measure: Adherence to the yoga sessions and the application
timeFrame: At 3 months (After completion of the intervention)
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of oncology, university hospital
Study officials:
affiliation: Department of Medical and Health sciences, Linköping university, Sweden
name: Anna Strömberg, PHD
role: PRINCIPAL_INVESTIGATOR
References: