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Research Article: Efficacy of a physiotherapy, yoga and patient education programme for patients with breast cancer and hormone therapy-induced pain: a multicentre randomised study protocol (SKYPE 2)

Date Published: 2024-01-08

Abstract:
Introduction Osteoarticular pain is experienced by approximately 50% of patients with breast cancer under hormone therapy and can increase the risk of therapy discontinuation. Among complementary therapies, yoga has shown efficacy regarding reduction of fatigue, anxiety, pain due to hormone therapy and inflammation. Personalised patient education programmes increase engagement and motivation, and induce effective behavioural changes. The SKYPE programme, an integrated intervention combining physiotherapy, yoga and patient education, showed promising efficacy on hormone therapy-induced pain in a previous pilot study. In this study, we hypothesised that using theory-based patient education favour learning and practising 15?min of at-home yoga every day to decrease hormone therapy-induced pain. Methods and analysis This multicentre randomised study will assess the efficacy of the SKYPE programme on pain reduction compared with standard care in patients with breast cancer reporting osteoarticular pain due to hormone therapy. Main secondary objectives will describe pain evolution and characteristics, patient adhesion to yoga sessions and home practice, forward flexibility, quality of life, fatigue, anxiety and compliance to hormone therapy. Patients in the intervention group will participate in 1?weekly educational yoga session of 90?min for 6?weeks, supervised by physiotherapists (period 1). They will also perform daily at-home 15?min yoga sessions for 12 weeks, the total duration of the intervention (periods 1 and 2). Pain will be evaluated during physiotherapy check-ups at baseline (T0), at 6 weeks (T1) and at 12 weeks (T2). Ethics and dissemination This study was approved by the ethics committee (CPP Ile de France 8 on 22 June 2020). The results will be disseminated to patients and healthcare professionals, and published in a peer-reviewed journal. Trial registration number NCT04457895 .

Introduction:
Oestrogen-positive breast cancers account for 65%–75% of all early breast cancer cases and require adjuvant hormone therapy (HT) after initial treatment, 1 administered for a long time period, usually 5 years and up to 10 years for some patients. 2 During treatment, as much as 50% of women report osteoarticular and/or musculoskeletal pain. 3 4 HT-related side effects constitute a major issue with consequences on patients’ quality of life (QoL), treatment efficiency, including dose reductions or early treatment…

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