NCT07210905

Implementation of the 3-steps Assess-Advise-Refer Exercise (FitARise) Protocol as a Standard Practice in Cancer Care

Implementation of the 3-steps Assess-Advise-Refer Exercise (FitARise) Protocol as a Standard Practice in Cancer Care: A Stepped-wedge Cluster Randomized Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study proposes to evaluate the process and outcome of an implementation program designed to implement the American College of Sports Medicine (ACMS)-recommended exercise assessment, advice, and referral instruction as standard practices in routine cancer care.

Detailed description

This study aims to test whether using implementing strategies (audit, feedback, facilitation, and adaptable workflow) to adopt the systematic FitARise protocol increases the proportion of eligible patients assessed, advised, and referred compared to control with the availability of the protocol, but without implementation strategies. This study hypothesizes that implementing strategies to promote the protocol's adoption will increase the proportion of eligible patients assessed and advised by oncologists and the proportion of patients referred to the JCICC exercise-based weight management program. For process evaluation, this study aims to use qualitative methods to assess the experience and response to the implementation program. The primary outcome (the reach measurement) is the percentage of eligible patients assessed, advised, and referred based on predefined BMI scores.

Conditions

• Exercise
• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	3-step Assess-Advice-Refer	Four implementation strategies will be conducted individually for each of the study unit at the timepoint when the study unit is being randomly allocated to the implementation condition. For each study unit, all site facilitators will first receive a half-day training. Each study unit under the implementation condition will receive weekly audit and feedback reports to summarize the proportion of eligible patients, proportion of eligible patients being screened, proportion of patients appropriately referred to JCICC. The senior research assistant with a nursing background will receive training and mentoring from the PI and will be the guided facilitator. The guided facilitator will conduct weekly site visits to address operational issues arise during the implementation. Lastly, while the FitARise protocol is standardized and cannot be modified, the routine workflow for each study unit can be adjusted according to its context and resources.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-02-02
• Completion: 2028-02-02
• First posted: 2025-10-07
• Last updated: 2025-12-10

Locations

8 sites across 1 country: Hong Kong