BACKGROUND: Breast cancer survivors (BCSs) are at increased risk of late effects. While research has reported positive effects of exercise therapy on fatigue and health-related quality of life (HRQoL) among short-term BCSs, evidence in long-term survivors remains scarce. METHODS: The CAUSE (CArdiovascUlar Survivors Exercise) trial was a two-armed randomized controlled trial. Long-term BCSs were assigned to five months of thrice-weekly supervised aerobic exercise or usual care. Late effects and HRQoL were assessed by Chalder Fatigue Questionnaire, European Organization for Research and Treatment of Cancer QLQ-BR23 and QLQ-C30 questionnaires, and Scale for Chemotherapy-Induced Long-term Neurotoxicity at baseline (T0), post-intervention (T1) and one-year follow-up (T2). RESULTS: In total, 140 BCSs (mean age 59.0 +/- 6.4 years, 11 +/- 1 years post-treatment) were included. Loss to follow-up at T1 was 6% and 19% in the exercise- and usual care group, respectively. From T0 to T1, the exercise group significantly improved total fatigue (between groups mean difference (MD) -3.0, p < 0.001), body image (MD 6.7, p = 0.043), physical- (MD 3.2, p <= 0.001), role- (MD 9.6, p = 0.019), and cognitive function (MD 3.4, p = 0.038), insomnia (MD -9.0, p = 0.017), and global health/QoL (MD 5.3, p <= 0.001) compared to usual care. The exercise benefits were more pronounced in BCSs experiencing versus not experiencing late effects at baseline. At one-year follow-up, most improvements regressed toward baseline values. CONCLUSION: Aerobic exercise significantly improves fatigue, body image, physical-, role-, and cognitive function, insomnia, and HRQoL in long-term BCSs. These findings suggest that exercise therapy should be a core component of managing late effects and enhancing HRQoL in long-term BCSs. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Registration number: NCT04307407.

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