- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06248450
Medical YOga dUring CANcer Treatment in a Digital or Physical Setting - a PREFERensbased Study (YouCanPrefer)
Medical Yoga During Cancer Treatment in a Digital or Physical Setting - a Preference-based Study
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Linköping, Sweden, 58185
- Department of oncology, university hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Physical setting
Medical yoga at a yoga local led by a yoga-instructor for 75 minutes once a week and individual yoga for a minimum of 10 minutes daily using a yoga-application for 12 weeks.
|
Medical yoga is a therapeutic form of Kundalini yoga led by a certified yoga instructor that uses different standardized yoga programs with a combination of physical postures, breathingexercises, and relaxation/meditation.
|
|
Other: Digital setting
Medical yoga online using videoconference system led by a yoga-instructor for 75 minutes once a week and individual yoga for a minimum of 10 minutes daily using a yoga-application for 12 weeks.
|
Medical yoga is a therapeutic form of Kundalini yoga led by a certified yoga instructor that uses different standardized yoga programs with a combination of physical postures, breathingexercises, and relaxation/meditation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients preferences to yoga during oncological treatment
Time Frame: Baseline, 3 months and 6 months
|
Interviews on choice of yoga setting: physical or digital
|
Baseline, 3 months and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life
Time Frame: Baseline, 3 months and 6 months
|
Health-related quality of life will be assessed by The European Organisation for Research and Treatment of Cancer, Quality of life Questionnaire C30 (EORTC QLQ-C30) which consists of a 30-item questionnaire, covering a global health status/quality of life (QoL) scale, five functioning scales, three symptom scales and six items concerning symptoms.
All scales and single-item measures were transformed to scores in the range 0-100.
A higher score on the global status scale and the functional scales denotes a high level of health and functioning, while a higher score on the symptomatic scale denotes a high level of symptom burden
|
Baseline, 3 months and 6 months
|
|
Health
Time Frame: Baseline, 3 months and 6 months
|
Health will be assessed with EuroQoL which consist of two parts: EuroQoL 5 dimensions 5 levels (EQ 5D 5L) and EuroQoL Visual Analogue Scale (EQ-VAS). EQ-5D 5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' =100 and 'The worst health you can image' =0. |
Baseline, 3 months and 6 months
|
|
Anxiety and depression
Time Frame: Baseline, 3 months and 6 months
|
The Hospital Anxiety and Depression Scale (HADS) will be used to measure anxiety and depression.
The scale consists of 14 items, with seven items related to anxiety and seven related to depression.
Each item is scored on a likert scale ranging from 0 to 3, with responses indicating the severity of the symptom from 0=no symptoms to 3= severe symptoms.
|
Baseline, 3 months and 6 months
|
|
Fatigue
Time Frame: Baseline, 3 months and 6 months
|
Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI).
The questionnaire consists of 20 items, measuring five subscales of MFI: General, Physical and Mental Fatigue, Reduced Motivation and Reduced Activity.
Each item is scored on a likert scale ranging from 1 to 5. Higher scores indicate higher levels of fatigue.
|
Baseline, 3 months and 6 months
|
|
Sleep
Time Frame: Baseline, 3 months and 6 months
|
Sleep will be measured with Minimal Insomnia Symptom Scale (MISS).
The questionnaire consists of 3 items.
Each item is scored on a likert scale ranging from 0 to 4, with responses indicating the severity of the symptom from 0=no symptoms to 5= severe symptoms.
|
Baseline, 3 months and 6 months
|
|
Stress
Time Frame: Baseline, 3 months and 6 months
|
Stress will be measured by the questionnaire The Perceived Stress Scale (PSS) which measures general stress and coping capabilities.
The instrument has 14 items with 4 alternatives to each item.
A higher score indicates higher stress.
Each item minimum 0 and maximum 4.
|
Baseline, 3 months and 6 months
|
|
Physical Activity
Time Frame: Baseline, 3 months and 6 months
|
Accelerometer
|
Baseline, 3 months and 6 months
|
|
Adherence to the yoga sessions and the application
Time Frame: At 3 months (After completion of the intervention)
|
Attendance at yoga-class and time spent (minutes) using the application
|
At 3 months (After completion of the intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Strömberg, PHD, Department of Medical and Health sciences, Linköping university, Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-04481-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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