24-week home-based walking program in the early adjuvant setting in breast cancer patients who receive aromatase inhibitor endocrine therapy: lessons learned from the SAKK 95/17 WISE prospective, randomized, multicenter trial.
A structured walking program increased daily step counts in breast cancer patients on aromatase inhibitors, but did not significantly reduce pain or AIA symptoms.
Where it sits
this study against the rest of the leuprorelin corpusSummary and findings
This study measured the effect of a 24-week home-based walking program on symptom burden and medication adherence in 320 early-stage breast cancer patients receiving aromatase inhibitor therapy. Participants were randomly allocated to an intervention group (n=158) or a control group (n=162), with the intervention group walking briskly outdoors for 30 minutes five days a week. The study found no significant difference in the incidence of aromatase inhibitor-induced arthralgia/myalgia between the two groups.
Abstract
<h4>Background</h4>Aromatase inhibitor (AI) induced arthralgia/myalgia (AIA) is a frequent side-effect of adjuvant breast cancer (BC) endocrine therapy. We investigated the effect of a user-friendly activity tracker to accompany a 24-week walking program, from the start of adjuvant AI-therapy, on patient AIA symptom burden and medication adherence.<h4>Methods</h4>320 early-stage BC patients were included and randomly allocated to the intervention (arm A, n = 158) or control arm (arm B, n = 162). The intervention in arm A was aimed at briskly walking outdoors for 30 min continuously with 100 steps/minute for 5 days a week, versus an unspecified recommendation of physical activity (PA) in arm B. The patients wore an activity tracker with a customized display.<h4>Results</h4>The intervention compliance in arm A was high, 94% of patients completed the 24-week intervention phase and 68% reached the recommended intervention PA goal. Median daily number of steps was higher in arm A (8542 vs. 7742; p = 0.015). At the end of the intervention phase, activity levels were higher in the intervention group (79.1% vs. 72.8%). These higher values remained unchanged in the follow-up phase at 12 months (79.1% vs. 69.8%) and at 24 months (69.6% vs. 61.1%). Neither the high incidence of AIA during the intervention phase (A:58.2% vs. B:56.2%) nor the reported pain levels differed between the trial arms.<h4>Conclusion</h4>BC patients are highly motivated to pursue new approaches for health promotion in addition to oncological therapies. Activity trackers with training instructional guidance are useful for maintaining training levels achieved over a longer period of time.
Background
This paper addresses the impact of aromatase inhibitor-induced arthralgia/myalgia (AIA) in breast cancer patients undergoing endocrine therapy. Prior research has indicated that AIA is a common side effect that can affect treatment adherence and quality of life. This study is significant as it evaluates a structured walking program's potential to mitigate these effects and improve patient engagement with physical activity.
Methods
The study was a prospective, randomized, multicenter trial involving 320 early-stage breast cancer patients. Participants were randomly assigned to either an intervention group (arm A) or a control group (arm B). The intervention group engaged in brisk walking for 30 minutes at 100 steps/minute, five days a week, while the control group received unspecified physical activity recommendations. Primary outcomes included compliance rates and daily step counts, measured over 24 weeks.
Results
The primary endpoint showed that the median daily number of steps was significantly higher in the intervention group (8542 steps) compared to the control group (7742 steps), with a p-value of 0.015. Compliance was high, with 94% of participants in arm A completing the intervention. However, the incidence of AIA was similar between groups, with 58.2% in arm A and 56.2% in arm B, indicating no significant difference in pain levels.
Interpretation
While the study demonstrates a statistically significant increase in daily step counts for the intervention group, the clinical significance of this finding is uncertain, particularly given the lack of difference in AIA incidence and pain levels. The high completion rate suggests good adherence to the walking program, but the absence of a significant impact on AIA symptoms raises questions about the intervention's overall effectiveness. Potential confounds include the unspecified nature of the control group's physical activity recommendations and the reliance on self-reported data.
Key findings
- 94% of patients in arm A completed the 24-week intervention phase.
- Median daily number of steps was higher in arm A (8542 vs. 7742; p=0.015).
- Activity levels at the end of the intervention phase were higher in arm A (79.1% vs. 72.8%).
- At 12 months, activity levels remained higher in arm A (79.1% vs. 69.8%).
- At 24 months, activity levels were still higher in arm A (69.6% vs. 61.1%).
- Incidence of AIA during the intervention phase was similar (A:58.2% vs. B:56.2%).
Limitations
- No significant difference in AIA incidence between groups.
- Pain levels reported were similar across groups.
- Unspecified physical activity recommendations for control group.
- Long-term clinical significance of increased step counts is unclear.
- Potential reliance on self-reported data.