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Background &amp; methods <p>Hot flashes are a common side effect of androgen deprivation therapy in metastatic castration-sensitive prostate cancer (mCSPC). As part of the LIBERTAS trial evaluating an androgen-deprivation (ADT)-sparing maintenance regimen in mCSPC patients, novel exploratory endpoints of sleep quality and physical activity levels are being developed as objective and quantifiable proxies for hot flash burden. Actigraphy devices were given to study participants to capture data on sleep and physical activity. A workflow designed to increase participant wear of actigraphy devices was implemented three months into the study.</p> Results <p>After workflow deployment, the daily mean, variability, and long-term trend of adherence to wearing actigraphy device improved significantly and substantially. LIBERTAS participants wore an actigraphy device nearly 22&#xa0;hours a day on average for over 12 months after workflow deployment, compared to less than 19&#xa0;hours daily prior. In sensitivity analyses with wear thresholds of 18 and 22&#xa0;hours, 86% and 76% of observed days were retained for analysis respectively. Mean sleep efficiency was approximately 75% and mean step count was approximately 3,700 steps daily.</p> Conclusion <p>The results of the newly implemented LIBERTAS site intervention workflow demonstrate that patients with advanced cancer can be high-adherence users when given the appropriate support. This study also provides a data-driven blueprint for other researchers looking to optimize actigraphy data capture.</p> Trial registration <p>This study is registered at Clinicaltrials.gov NCT05884398 (Registration date: 23 May 2023).</p>

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Improving actigraphy adherence among clinical trial participants with a real-time data-driven workflow

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月8日

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  • Alana O’Brien Del Campo,
  • Daniel Sanchez,
  • Meenakshi Chatterjee,
  • Nikolay V. Manyakov,
  • Alex dos Santos,
  • Suneel Mundle,
  • Mark Wildgust,
  • Mark Sapp,
  • Rana Zia Ur Rehman,
  • Neeraj Agarwal,
  • Arun A. Azad,
  • Brian D. Gonzalez,
  • Alicia K. Morgans,
  • Ashita S. Batavia

摘要

Background & methods

Hot flashes are a common side effect of androgen deprivation therapy in metastatic castration-sensitive prostate cancer (mCSPC). As part of the LIBERTAS trial evaluating an androgen-deprivation (ADT)-sparing maintenance regimen in mCSPC patients, novel exploratory endpoints of sleep quality and physical activity levels are being developed as objective and quantifiable proxies for hot flash burden. Actigraphy devices were given to study participants to capture data on sleep and physical activity. A workflow designed to increase participant wear of actigraphy devices was implemented three months into the study.

Results

After workflow deployment, the daily mean, variability, and long-term trend of adherence to wearing actigraphy device improved significantly and substantially. LIBERTAS participants wore an actigraphy device nearly 22 hours a day on average for over 12 months after workflow deployment, compared to less than 19 hours daily prior. In sensitivity analyses with wear thresholds of 18 and 22 hours, 86% and 76% of observed days were retained for analysis respectively. Mean sleep efficiency was approximately 75% and mean step count was approximately 3,700 steps daily.

Conclusion

The results of the newly implemented LIBERTAS site intervention workflow demonstrate that patients with advanced cancer can be high-adherence users when given the appropriate support. This study also provides a data-driven blueprint for other researchers looking to optimize actigraphy data capture.

Trial registration

This study is registered at Clinicaltrials.gov NCT05884398 (Registration date: 23 May 2023).