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This study outlines a process evaluation protocol for a home-based exercise program to manage persistent taxane-induced neuropathy in breast cancer survivors. It enhances transparency and participant-centered care in clinical trials.

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Area of Science:

  • Neurology
  • Oncology
  • Rehabilitation Medicine

Background:

  • Evaluation publications often omit study modifications, hindering reproducibility.
  • This protocol details a process evaluation for a home-based exercise intervention targeting persistent taxane-induced neuropathy.
  • The study focuses on women with breast cancer experiencing neuropathy after taxane treatment.

Purpose of the Study:

  • To present a detailed process evaluation protocol for a home-based gait, balance, and resistance exercise intervention.
  • To enhance transparency and facilitate replication of findings in future clinical trials.
  • To incorporate a participant-centered approach in research and data collection.

Main Methods:

  • The process evaluation runs parallel to a longitudinal randomized controlled trial (ClinicalTrials.gov: NCT04621721).
  • Utilizes flowcharts for standardized intervention implementation and fidelity procedures for participant comfort and needs assessment.
  • Employs systematic registration of recruitment procedures and implementation factors to prevent protocol deviations.

Main Results:

  • Process evaluation allows for early detection of intervention effects, both positive and negative.
  • Identifies factors impacting intervention implementation, enabling proactive adjustments.
  • Facilitates tailoring of individual attention and research focus to minimize protocol deviations.

Conclusions:

  • Publishing the evaluation protocol enhances clinical trial transparency and promotes future study replication.
  • Systematic tracking via process evaluation aids in understanding and addressing intervention inconsistencies.
  • Integrates a participant-centered element, allowing for a patient-centered approach to data collection and intervention delivery.