Early adapted physical activity to prevent and manage aromatase inhibitor-induced musculoskeletal pain in breast cancer: protocol for a hybrid effectiveness-implementation randomised controlled trial (APIS)
BMJ Open Sport Exerc Med. 2026 May 14;12(2):e003179. doi: 10.1136/bmjsem-2025-003179. eCollection 2026.
ABSTRACT
Aromatase inhibitors are the standard adjuvant hormone therapy for postmenopausal women with hormone-sensitive breast cancer. However, nearly half of patients experience aromatase inhibitor-associated musculoskeletal syndrome (AIMSS), predominantly pain, which compromises quality of life and treatment adherence. While adapted physical activity offers proven benefits in oncology, its specific role in preventing or managing AIMSS remains unclear. Moreover, the maintenance of physical activity throughout the care pathway in real-world settings is limited, underscoring the need for hybrid approaches that assess both clinical effectiveness and implementation. In response to these challenges, the primary study aim will be to compare the prevalence of musculoskeletal pain at 6 months of aromatase inhibitor therapy between patients who initiate a personalised, adapted physical activity programme at the beginning of the care pathway and those who receive usual care.
Secondary aims will be to (1) assess additional effects of the intervention on physical health, psychosocial well-being and treatment adherence, (2) explore contextual factors influencing programme implementation in routine oncology care and (3) identify potential risk factors for the development of AIMSS. The APIS study is a hybrid type I effectiveness-implementation randomised controlled trial including 182 postmenopausal women with non-metastatic hormone-sensitive breast cancer.APIS will generate new evidence on the clinical and implementation effectiveness of early personalised adapted physical activity in preventing AIMSS. The hybrid design will support the development of sustainable, patient-centred interventions potentially improving quality of life, adherence to hormone therapy and long-term outcomes in breast cancer survivorship.
Trial registration number NCT07295457.
PMID:42158292 | PMC:PMC13182384 | DOI:10.1136/bmjsem-2025-003179