Digitally Distributed Yoga for Women Treated for Breast Cancer

NCT04812652 | Active Not Recruiting

• 1 other identifier: 275078
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 3

Brief Summary

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?

Conditions

Breast Neoplasm Female

Keywords

breast neoplasm; breast cancer; yoga; digital intervention; eHealth; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Cancer related fatigue

  The Multidimensional Fatigue inventory (MFI) is a 20-item self-reported questionnaire including 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation is a state of physical, emotional, cognitive tiredness or exhaustion related to cancer. The score can be between 20 and 100. Higher score indicate higher fatigue.

  Baseline is 1 months after surgery and change after 3, 6, 24 and 48 months after breast cancer surgery

Secondary Outcomes (3)

• Change in Stress

  Baseline is 1 months after surgery and change after 3, 6, 24 and 48 months after breast cancer surgery

• Change in Health related Quality of Life (HRQoL)

  Baseline is 1 months after surgery and change after 3, 6, 24 and 48 months after breast cancer surgery

• Change in Quality of life

  Baseline is 1 months after surgery and change after 3, 6, 24 and 48 months after breast cancer surgery

Other Outcomes (16)

• Changes in physical activity

  Baseline is 1moths after surgery and changes at 3, 6 and 12 months after surgery

• Changes in IL-1

  Baseline is 1 months after surgery and changes are measured at 3 and 6 months after surgery

• Diagnose related measurement: Side effects

  After one and two year.

Study Arms (2)

Intervention group: Digitally distributed yoga

EXPERIMENTAL

Type of yoga: Physical yoga sequences that through scientific evaluation have proven to be effective and relevant for the target group. There will be 3 different programs during the 12-week-intervention Dose: twice weekly for 12 weeks; one yoga class live broadcasted and digitally distributed to the patient's computer or mobile device, and one class pre-recorded video for self-training. Sequences: The yoga class will be 60 minutes including 10 minutes of final relaxation. Thereafter, a 5 minutes reflection will be offered. Home Training: Instructions for yoga home practice will be standardized. The three yoga programs will be distributed in video-links for the participants to view at a time-point that suits them during the week. The recommendation will be to yoga at home once a week in addition to the digital yoga class in real time. Participants are expected to use their own computer or mobile device.

Behavioral: Digitally distributed yoga

Control group: Regulare care

NO INTERVENTION

Receive regular care, including written standardized information about the importance of physical activity by their contact nurse or physiotherapist, when discharged from the hospital accordingly to the routines at the clinic.

Interventions

Digitally distributed yoga BEHAVIORAL

Yoga distributed through internet.

Also known as: DigiYogaCaRe

Intervention group: Digitally distributed yoga

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosed with breast cancer Adult women Must have undergone breast cancer surgery with curative intention Must be Swedish speaking Must be able to read

You may not qualify if:

• Metastatic disease Received neoadjuvant treatment before surgery Advanced recurrent disease Unstable cardiovascular disease Brain or bone metastasis Unstable medical condition that might be aggravated by yoga.

Sponsors & Collaborators

• Region Örebro County: lead
• The Swedish Breast Cancer Association: collaborator
• Uppsala-Örebro Regional Research Council: collaborator

Study Sites (3)

Gävle sjukhus

Gävle, 80188, Sweden

Location

University Health Care Center

Örebro, 70185, Sweden

Location

Västmanlands Hospital

Västerås, 72189, Sweden

Location

Related Publications (3)

• Ohlsson Nevo E, Arvidsson-Lindvall M, Hellerstedt Borjeson S, Hagberg L, Hultgren Hornqvist E, Valachis A, Wickberg A, Duberg A. Digitally distributed Yoga Intervention in Breast Cancer Rehabilitation (DigiYoga CaRe): protocol for a randomised controlled trial. BMJ Open. 2022 Nov 1;12(11):e065939. doi: 10.1136/bmjopen-2022-065939.

  PMID: 36319059 BACKGROUND

• Nilsson MB, Arvidsson Lindvall M, Fesse PWT, Hellerstedt-Borjesson S, Ohlsson-Nevo E, Duberg A. Experiences of Home-Based Participation in a Digitally Distributed Yoga Intervention in Breast Cancer Rehabilitation: Qualitative Content Analysis. J Med Internet Res. 2025 Nov 20;27:e75975. doi: 10.2196/75975.

  PMID: 41264913 DERIVED

• Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520.

  PMID: 40421669 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Emma Ohlsson-Nevo, PH.D

  University Healthcare Research Center, Region Örebro County, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: March 23, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)