Process evaluation protocol plan for a home-based physical activity intervention versus educational intervention for...

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.