Home-based patient-centered physical activity program for quality of life preservation during neoadjuvant chemotherapy in breast cancer: the AURORA randomized controlled trial protocol.

[BACKGROUND] Despite the known benefits of physical activity for women with breast cancer (BC), adherence to recommended guidelines remains low, especially during neo-adjuvant chemotherapy. The Aurora intervention presents a multidimensional approach to improve physical activity adherence, considering the patient's emotional and physical needs and barriers to physical activity. This protocol aims to evaluate Aurora's effects compared to standard care in BC patients.

[METHODS] In this 9-week randomized controlled trial, 30 female BC patients under 70 years of age, undergoing neo-adjuvant chemotherapy in the Metropolitan Region of Chile, will be recruited. Participants will receive a standard online education class on the benefits of physical activity for BC patients, which includes general information on the importance of exercise during treatment, recommended physical activity guidelines, and tips for safely incorporating movement into daily routines. Afterward, participants will be randomly allocated in a 1:1 ratio to either the 9-week Aurora experimental program (Aurora experimental kit: branded box containing exercise equipment, designed logbook journal, hydration bottle, exercise leaflet, and arm volume measurement tape) or the Aurora control program (Aurora control kit: branded tote bag containing a blank notebook, hydration bottle, and exercise leaflet). The study will employ a mixed-methods approach to assess multidimensional treatment effects through baseline and post-intervention measurements. The primary outcome will be quality of life, which will be assessed using questionnaires and patient perceptions, with thematic analysis of patient-recorded journals and in-depth group interviews to evaluate emotional treatment effects. Secondary outcomes will include (1) functional capacity tests to measure adverse physical effects and (2) biological markers assessed through lipid profiling, inflammation biomarkers, and tumor progression.

[DISCUSSION] Our conceptual hypothesis is that the Aurora intervention program will positively impact primary and secondary outcomes compared to the control group. Integrating the behavior change COM-B model and a patient-centered design facilitates tailoring interventions to BC patients' multidimensional needs and barriers. Additionally, we expect the Aurora program to promote more significant effects than standard care on physical activity adherence, intensity, and time.

[TRIAL REGISTRATION] The study was registered at ClinicalTrials.gov, NCT06449417. Registered on May 28, 2024. Unique Protocol ID: 230126002. https://clinicaltrials.gov/study/NCT06449417 .