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NCT Number: NCT07210905

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KWH Department of Surgery, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Cancer patients):

  • All cancer patients with BMI score>=23;
  • Have completed cancer treatment within the past five years;
  • At least 18 years old;
  • Are literate in Chinese or English;
  • Are eligible to attend the intervention program.

Exclusion criteria

(Cancer patients):

  • Patients who have completed cancer treatments for more than five years;
  • Non-Cantonese, non-Mandarin, non-English speakers.

Inclusion criteria

(Clinical staff):

  • All clinical, medical or surgical oncologists at the study units during the study period.

Exclusion criteria

(Clinical staff):

  • No exclusion criterial for staff.

Treatment and study plan

3-step Assess-Advice-Refer

Behavioral

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.

Other names: FitARise

Primary outcomes

  1. Percentage of eligible patients

    Time frame: Pre- and post-implementation phase, up to 24 months

    The primary outcome (the reach measurement) is the percentage of eligible patients assessed, advised, and referred based on predefined BMI scores.

Secondary outcomes

  1. Change in referral uptake

    Time frame: Pre- and post-implementation phase, up to 24 months

    The secondary outcome is the uptake of the referral, i.e. the proportion of referred patients accepting the enrolment of the JCICC weight management program. This study also will examine the attendance rates of those enrolled in the weight management program.

Study contacts

Contact information is provided by the study sponsor or research team.

Wendy Lam, PhD

CONTACT

[email protected]

+852 39179878

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 7, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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