eprintid: 14247 rev_number: 7 eprint_status: archive userid: 2 dir: disk0/00/01/42/47 datestamp: 2024-09-18 23:30:13 lastmod: 2024-09-18 23:30:14 status_changed: 2024-09-18 23:30:13 type: article metadata_visibility: show creators_name: May, Anne creators_name: Hiensch, Anouk creators_name: Depenbusch, Johanna creators_name: Schmidt, Martina creators_name: Monninkhof, Evelyn creators_name: Peláez, Mireia creators_name: Clauss, Dorothea creators_name: Zimmer, Philipp creators_name: Belloso, Jon creators_name: Trevaskis, Mark creators_name: Rundqvist, Helene creators_name: Wiskemann, Joachim creators_name: Muller, Jana creators_name: Fremd, Carlo creators_name: Altena, Renske creators_name: Kufel-Grabowska, Joanna creators_name: Bijlsma, Rhode creators_name: van Leeuwen-Snoeks, Lobke creators_name: Bokkel-Huinink, Daan ten creators_name: Sonke, Gabe creators_name: Mann, Bruce creators_name: Francis, Prudence creators_name: Richardson, Gary creators_name: Álvarez, Isabel creators_name: Malter, Wolfram creators_name: Van der Wall, Elsken creators_name: Aaronson, Neil creators_name: Senkus, Elżbieta creators_name: Urriticoechea, Ander creators_name: Zopf, Eva creators_name: Bloch, Wilhelm creators_name: Stuiver, Martijn creators_name: Wengström, Yvonne creators_name: Steindorf, Karen creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: mireia.pelaez@uneatlantico.es creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: creators_id: title: Abstract GS02-10: Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study ispublished: pub subjects: uneat_bm subjects: uneat_dp divisions: uneatlantico_produccion_cientifica full_text_status: none abstract: INTRODUCTION: Patients with metastatic breast cancer (mBC) often experience cancer- and treatment-related side effects that can impair daily life activities and health-related quality of life (HRQoL). Interventions are needed that improve HRQoL by alleviating fatigue and other side effects during palliative BC cancer treatment. Recent evidence-based international guidelines (ASCO, ACSM) recommend exercise for patients with BC during adjuvant treatment for reducing side effects. However, evidence of the effectiveness of exercise in patients with mBC is scarce. The PREFERABLE-EFFECT study (NCT04120298) was designed to assess the effects of a 9-month supervised exercise program in patients with mBC on fatigue, HRQoL, and other cancer- and treatment-related side effects. METHODS: PREFERABLE-EFFECT is a multinational, randomized controlled trial including patients with mBC from five European countries (Germany, Poland, Spain, Sweden, The Netherlands) and Australia. Participants were randomly assigned to usual care or an individualized, structured exercise program consisting of aerobic, resistance, and balance training. The first six months included twice weekly supervised exercise sessions of one hour. In the last three months, one supervised session was replaced by an unsupervised session, supplemented by an exercise App. All participants received general exercise advice (physical activity ≥ 30 min/day) and an activity tracker. Our primary outcomes, physical fatigue (subscale of the EORTC QLQ-FA12) and HRQoL (summary score of the EORTC QLQ-C30), were assessed at baseline, 3, 6, and 9 months. Among other physical fitness outcomes, maximal short exercise capacity was assessed with the Steep Ramp Test. The intervention effects (intention-to-treat) were determined by comparing the change from baseline to 3, 6 (i.e., primary endpoint) and 9 months between groups using separate mixed models for repeated measures, adjusted for baseline values of the outcome variable and stratification factors (mBC line of treatment (1st/2nd vs. 3rd or higher) and study center). A significant improvement of either or both primary outcomes (applying the Bonferroni-Holm method) was considered as successful. RESULTS: Between 2019-2022, we included 357 patients with mBC, with 178 patients randomized to the exercise intervention and 179 to usual care. Patients were, on average, 55.4 years of age (SD=11.1), most patients received 1st or 2nd line of treatment at study enrollment (74.8%) and had bone metastases (73.9%). At 6 months (primary endpoint), participation in the exercise intervention resulted in statistically significant positive effects on both primary outcomes, compared to usual care: physical fatigue was lower (mean difference: -5.3, 95% CI -10.0; -0.6, p=0.027, effect size (ES)=0.22) and HRQoL was better (+4.8, 95% CI 2.2; 7.4, p=0.0003, ES=0.33). Beneficial effects were also found at 3 months (physical fatigue: -3.4, -7.8; 1.0, ES=0.14 and QoL: 3.9, 1.5; 6.3, ES=0.27) and 9 months (physical fatigue: -5.6, -10.9; -0.4, ES=0.24 and QoL: +4.3, 1.4; 7.3, ES=0.31). Further, at the primary endpoint, we found positive exercise effects on physical fitness (+24.3 Watts, 15.5; 33.1, ES=0.42) and numerous QLQ-C30 scales, including social functioning (+5.5, 0.2; 10.8, ES=0.20), pain (-7.1, -12.1; -1.9, ES=0.28) and dyspnea (-7.6, -12.2; -3.0, ES=0.28). Two SAEs occurred (one wrist fracture and one sacral stress fracture), neither related to bone metastases. CONCLUSION: This large multinational study demonstrated significant beneficial effects of a supervised exercise intervention offered during palliative treatment on mBC patients’ fatigue, HRQoL, and other clinically relevant outcomes. Based on these findings, we recommend supervised resistance and aerobic exercise as part of supportive care regimens during palliative treatment of mBC. date: 2024-05 publication: Cancer Research volume: 84 number: 9_Supp pagerange: GS02-10 id_number: doi:10.1158/1538-7445.SABCS23-GS02-10 refereed: TRUE issn: 1538-7445 official_url: http://doi.org/10.1158/1538-7445.SABCS23-GS02-10 access: close language: en citation: Artículo Materias > Biomedicina Materias > Educación física y el deporte Universidad Europea del Atlántico > Investigación > Artículos y libros Cerrado Inglés INTRODUCTION: Patients with metastatic breast cancer (mBC) often experience cancer- and treatment-related side effects that can impair daily life activities and health-related quality of life (HRQoL). Interventions are needed that improve HRQoL by alleviating fatigue and other side effects during palliative BC cancer treatment. Recent evidence-based international guidelines (ASCO, ACSM) recommend exercise for patients with BC during adjuvant treatment for reducing side effects. However, evidence of the effectiveness of exercise in patients with mBC is scarce. The PREFERABLE-EFFECT study (NCT04120298) was designed to assess the effects of a 9-month supervised exercise program in patients with mBC on fatigue, HRQoL, and other cancer- and treatment-related side effects. METHODS: PREFERABLE-EFFECT is a multinational, randomized controlled trial including patients with mBC from five European countries (Germany, Poland, Spain, Sweden, The Netherlands) and Australia. Participants were randomly assigned to usual care or an individualized, structured exercise program consisting of aerobic, resistance, and balance training. The first six months included twice weekly supervised exercise sessions of one hour. In the last three months, one supervised session was replaced by an unsupervised session, supplemented by an exercise App. All participants received general exercise advice (physical activity ≥ 30 min/day) and an activity tracker. Our primary outcomes, physical fatigue (subscale of the EORTC QLQ-FA12) and HRQoL (summary score of the EORTC QLQ-C30), were assessed at baseline, 3, 6, and 9 months. Among other physical fitness outcomes, maximal short exercise capacity was assessed with the Steep Ramp Test. The intervention effects (intention-to-treat) were determined by comparing the change from baseline to 3, 6 (i.e., primary endpoint) and 9 months between groups using separate mixed models for repeated measures, adjusted for baseline values of the outcome variable and stratification factors (mBC line of treatment (1st/2nd vs. 3rd or higher) and study center). A significant improvement of either or both primary outcomes (applying the Bonferroni-Holm method) was considered as successful. RESULTS: Between 2019-2022, we included 357 patients with mBC, with 178 patients randomized to the exercise intervention and 179 to usual care. Patients were, on average, 55.4 years of age (SD=11.1), most patients received 1st or 2nd line of treatment at study enrollment (74.8%) and had bone metastases (73.9%). At 6 months (primary endpoint), participation in the exercise intervention resulted in statistically significant positive effects on both primary outcomes, compared to usual care: physical fatigue was lower (mean difference: -5.3, 95% CI -10.0; -0.6, p=0.027, effect size (ES)=0.22) and HRQoL was better (+4.8, 95% CI 2.2; 7.4, p=0.0003, ES=0.33). Beneficial effects were also found at 3 months (physical fatigue: -3.4, -7.8; 1.0, ES=0.14 and QoL: 3.9, 1.5; 6.3, ES=0.27) and 9 months (physical fatigue: -5.6, -10.9; -0.4, ES=0.24 and QoL: +4.3, 1.4; 7.3, ES=0.31). Further, at the primary endpoint, we found positive exercise effects on physical fitness (+24.3 Watts, 15.5; 33.1, ES=0.42) and numerous QLQ-C30 scales, including social functioning (+5.5, 0.2; 10.8, ES=0.20), pain (-7.1, -12.1; -1.9, ES=0.28) and dyspnea (-7.6, -12.2; -3.0, ES=0.28). Two SAEs occurred (one wrist fracture and one sacral stress fracture), neither related to bone metastases. CONCLUSION: This large multinational study demonstrated significant beneficial effects of a supervised exercise intervention offered during palliative treatment on mBC patients’ fatigue, HRQoL, and other clinically relevant outcomes. Based on these findings, we recommend supervised resistance and aerobic exercise as part of supportive care regimens during palliative treatment of mBC. metadata May, Anne; Hiensch, Anouk; Depenbusch, Johanna; Schmidt, Martina; Monninkhof, Evelyn; Peláez, Mireia; Clauss, Dorothea; Zimmer, Philipp; Belloso, Jon; Trevaskis, Mark; Rundqvist, Helene; Wiskemann, Joachim; Muller, Jana; Fremd, Carlo; Altena, Renske; Kufel-Grabowska, Joanna; Bijlsma, Rhode; van Leeuwen-Snoeks, Lobke; Bokkel-Huinink, Daan ten; Sonke, Gabe; Mann, Bruce; Francis, Prudence; Richardson, Gary; Álvarez, Isabel; Malter, Wolfram; Van der Wall, Elsken; Aaronson, Neil; Senkus, Elżbieta; Urriticoechea, Ander; Zopf, Eva; Bloch, Wilhelm; Stuiver, Martijn; Wengström, Yvonne y Steindorf, Karen mail SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, mireia.pelaez@uneatlantico.es, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR (2024) Abstract GS02-10: Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study. Cancer Research, 84 (9_Supp). GS02-10. ISSN 1538-7445