JNCI cancer spectrum · 2026
Feasibility evaluation of a virtual lifestyle intervention for early-stage breast cancer survivors undergoing chemotherapy.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Tan Sim Yee Cindy, Addo Isaac Yeboah, Collett Gemma, Price Emily, Macdonald Eliza R, Gerber Shannon, Turner Jane, Lee Liane, Yau Hau Yi, Spencer Jaclyn, Saleem Sama, Pearson Antonia, Boyle Frances, Della-Fiorentina Stephen, Kiely Belinda E, Taylor Natalie, Yee Jasmine, Lourenco Richard De Abreu, Bauman Adrian, Dhillon Haryana M, Vardy Janette L
Аннотация
BACKGROUND: Weight gain and physical inactivity during chemotherapy for patients with early-stage breast cancer are common. We sought to investigate the feasibility of a virtual lifestyle (exercise and diet) intervention for breast cancer survivors during chemotherapy.
METHODS: This single-arm phase 2 trial delivered 12 weekly 1-hour telehealth sessions of supervised exercise and diet education to breast cancer survivors (patients with stage I-III disease) starting neoadjuvant chemotherapy. Screening, recruitment, intervention, and study assessments completed at baseline (T0), immediately after the intervention (T1), and 3 months after the intervention (T2) were conducted by telehealth in 2022-2023. The primary outcome was that at least 60% of participants achieved 50% of the predetermined exercise and dietary goals. Secondary outcomes were acceptability (participation, attendance, completion), physical health, and lifestyle outcomes.
RESULTS: Of 73 referrals, 60 individuals were eligible, 58 (97%) provided consent, 51 (85%) commenced the intervention, and 34 (57%) completed at least 1 postintervention assessment (completion rate = 67%). The mean (SD) age of participants was 51 (8.8) years, and 50% of participants were receiving neoadjuvant chemotherapy. Attendance was lower for exercise than for diet sessions (44% vs 62% attended ≥75% sessions). At T1, 36% of participants adhered to at at least 50% of the preset goals, improving at T2 (62.5%). Weight was not statistically significantly different between T0 and T1 (P = .199) but increased substantially at T2 (P = .018). Average waist circumference was reduced at T1 (‒1.9 cm, P = .014) and at T2 (‒3.3 cm, P < .001). Weekly exercise time increased by 38.5 minutes from T0 to T1 (P = .038), and the proportion of participants who met exercise guidelines improved from 6% (T0) to 41% (T2).
CONCLUSION: Our primary outcome was not achieved immediately after the intervention but was observed 3 months later. Individuals completing the intervention attended at least half the diet and exercise sessions during chemotherapy. Results of this study will inform design of a phase 3 study.
METHODS: This single-arm phase 2 trial delivered 12 weekly 1-hour telehealth sessions of supervised exercise and diet education to breast cancer survivors (patients with stage I-III disease) starting neoadjuvant chemotherapy. Screening, recruitment, intervention, and study assessments completed at baseline (T0), immediately after the intervention (T1), and 3 months after the intervention (T2) were conducted by telehealth in 2022-2023. The primary outcome was that at least 60% of participants achieved 50% of the predetermined exercise and dietary goals. Secondary outcomes were acceptability (participation, attendance, completion), physical health, and lifestyle outcomes.
RESULTS: Of 73 referrals, 60 individuals were eligible, 58 (97%) provided consent, 51 (85%) commenced the intervention, and 34 (57%) completed at least 1 postintervention assessment (completion rate = 67%). The mean (SD) age of participants was 51 (8.8) years, and 50% of participants were receiving neoadjuvant chemotherapy. Attendance was lower for exercise than for diet sessions (44% vs 62% attended ≥75% sessions). At T1, 36% of participants adhered to at at least 50% of the preset goals, improving at T2 (62.5%). Weight was not statistically significantly different between T0 and T1 (P = .199) but increased substantially at T2 (P = .018). Average waist circumference was reduced at T1 (‒1.9 cm, P = .014) and at T2 (‒3.3 cm, P < .001). Weekly exercise time increased by 38.5 minutes from T0 to T1 (P = .038), and the proportion of participants who met exercise guidelines improved from 6% (T0) to 41% (T2).
CONCLUSION: Our primary outcome was not achieved immediately after the intervention but was observed 3 months later. Individuals completing the intervention attended at least half the diet and exercise sessions during chemotherapy. Results of this study will inform design of a phase 3 study.