Effect of Pain Science Education and Behavioral Graded Activity on Pain in Survivors of Breast Cancer: A Study Protocol for a Multicenter Randomized Controlled Trial
Astrid Lahousse, Eva Roose, Laurence Leysen, David Beckwée, César Fernández de-las-Peñas, Christel Fontaine, Marian Vanhoeij, Eva Huysmans, Anneleen Malfliet, Jo NijsAbstract
IMPORTANCE
Pain affects up to half of survivors of breast cancer and is one of the most common long-term consequences of cancer treatment, yet it remains under-recognized and undertreated. Pharmacological options often provide limited relief and may cause adverse effects. Evidence from other pain populations supports a biopsychosocial approach combining pain education and physical activity.
OBJECTIVE
The objective is to evaluate whether pain science education (PSE) with behavioral graded activity (BGA) versus usual care (UC), reduces pain intensity and interference in survivors of breast cancer with pain. Secondary aims include assessing health-related quality of life (HRQoL) and central pain modulation.
DESIGN
This study is a multicenter, two-arm, assessor- and statistician-blinded, randomized controlled superiority trial.
SETTING
The trial will be conducted in Belgium, with interventions delivered in hospital and academic research settings.
PARTICIPANTS
Two hundred women with a history of breast cancer and persistent pain will be recruited.
INTERVENTIONS
Participants will be randomized to either (1) PSE (1 session) plus 5 BGA sessions delivered by a trained physical therapist, or (2) usual care with a standardized biomedical pain information leaflet, over a 12-week period.
MAIN OUTCOMES AND MEASURES
The primary outcome will be pain intensity and interference (Brief Pain Inventory). Secondary outcomes will include HRQoL (EORTC QLQ-C30) and central pain modulation (Quantitative Sensory Testing). Exploratory outcomes include sleep, fatigue, pain-related cognitions, and health care utilization. Assessments will be conducted at baseline, post-intervention, and at 3-month (primary endpoint), 1-year, and 2-year follow-ups.
CONCLUSIONS
This trial will determine whether a structured PSE+BGA program improves pain and HRQoL in survivors of breast cancer, offering a potential scalable non-pharmacological treatment.
RELEVANCE
These findings may guide targeted rehabilitation strategies and strengthen the role of physical therapists in managing post-cancer pain, particularly in light of the growing population of survivors of breast cancer and the increasing prevalence of persistent symptoms.