LBA12 - eMouvoir: Randomised phase III trial evaluating the impact of a personalized and remote physical activity (PA) for breast cancer survivors (BCS). Results on the quality of life (QoL)

Background

Cancer and treatments reduce QoL of BCS. PA offers many benefits including improved QoL. eMOUVOIR trial is a multicentre randomised phase 3 trial evaluating the benefit of personalised remote exercise and PA coaching in terms of QoL for BCS.

Methods

After cancer treatment, BCS were randomised 1:1 between experimental arm (EA, remote personalized coaching, monitoring using a connected watch, interactive PA video sessions for 4 months (mo) + 8 mo maintenance) and control arm (CA, standard supportive approach, including recommendations for PA practice). The primary endpoint was the absolute difference between baseline and 12-mo value of physical and mental health component summary (PCS and MCS, coprimary endpoints) of the SF36 QoL questionnaire. Secondary endpoints were the 4-mo SF36 difference, the score on the eight SF36 domains, self-completion questionnaires (fatigue, pain, depression, sleep), health economics, biometric measures, physical capacities, safety, and invasive disease free survival. Assuming a standard deviation of 15, we required 1020 evaluable patients (pts) to ensure a 80% power for a 3-point difference between treatment groups in PCS or MCS, with a 2-sided alpha=2.5%. Based on IMDC recommendations, accrual was stopped in May 2023, after 821 inclusions, due to lower than expected variance. Main analysis was performed on all pts with available SF36 at baseline and 12 mo. General linear model was used adjusted on baseline value and stratification factors.

Results

Among the 821 pts, 684 were included in the main analysis: 344 in CA, 340 in EA. Table: LBA12

Conclusions

Compared to standard PA recommendations, providing BCS patients with an intervention combining remote personalized coaching, connected device, interactive learning sessions with adapted PA objectives significantly increases patient’s QoL at the end of the intervention (4 mo), but not at a longer term horizon (12 mo).

Clinical trial identification

NCT04536584.

Editorial acknowledgement

Legal entity responsible for the study

Centre Oscar Lambret.

Funding

Institut National du Cancer.

Disclosure

All authors have declared no conflicts of interest.