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Digitally Distributed Yoga for Women Treated for Breast Cancer

Study acronym: DigiyogaCare
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: May 1, 2024 to May 1, 2028
    • Study completion date: Jul 1, 2026 to Jul 1, 2028
    v4
  2. Notable Primary completion date changed from estimate of Oct 1, 2023 to May 1, 2024v3 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 250 to confirmed 229
    • Study completion date: Oct 1, 2028 to Jul 1, 2026
    • Study description shortened, about 10 words
    • Site details revised at 3 of 3 sites
    • Collaborators expanded, about 9 words
    • Publications: details revised at 1 of 3 entries
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Study description shortened, about 75 words
    • Publications: 31 to 3
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Breast cancer is the most common cancer disease in women. As the prevalence of fatigue is high in this group it is motivated to find interventions that can reduce fatigue and render in an increased level of physical activity both during and after treatment. Yoga have shown effect on cancer related fatigue (CRF) and is a rehabilitation activity that is often requested by breast cancer patients. Breast cancer patients live in cites and small-towns as well as in rural areas and therefore there is a need for accessible rehabilitation activities for all patients despite place of residence. A digitally distributed yoga class can potentially increase accessibility for those living in rural areas. Aim The overarching aim of this study is to investigate the effect of a 12-weeks digitally distributed yoga intervention for women treated for breastcancer, compared with a control group receiving regular care, concerning: * patient reported outcomes, primary endpoint CRF * systemic inflammation * activity level The study will evaluate if there are differences during and after the intervention and if those differences are sustained after 1, 3, 6, 12 and 24 months after the intervention. Additional objectives are to compare the two groups concerning completing oncologic treatment, cost effectiveness, return to work and also to describe the patients experiences of participating in a digitally distributed yoga class at home. Research questions If and how a digitally distributed yoga can influence cancer related fatigue, stress, health related quality of life and level of physical activity compared to regular care? If and how a digitally distributed yoga can have an effect on systemic inflammation? How is the feasibility of digitally distributed yoga twice weekly at home? What is the breast cancer patients' experience of participating in digitally distributed yoga clas?
Trial Details
NCT Number NCT04812652
Lead Sponsor Region Örebro County
Collaborators: The Swedish Breast Cancer Association, Uppsala-Örebro Regional Research Council
Conditions
(from sponsor)
Breast Neoplasm Female
Related terms Breast Neoplasms
Enrollment 229 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov