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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
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07210905
Enrollment
1800
Registered
2025-10-07
Start date
2026-02-02
Completion date
2028-02-02
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Exercise

Keywords

Implementation study, Weight management, Cancer survivorship

Brief 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.

Interventions

BEHAVIORAL3-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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This study will use a stepped wedge cluster randomized controlled trial design in which the intervention is introduced stepwise across study units . After obtaining the consent form from the 9 oncology units, they will be randomized to one of the three roll-out schedules with a 4-month duration each. All the study units will start the trial in a control condition (i.e., no implementation strategies used). At each time point, a new group of 3 study units will cross over from the control condition to the implementation condition, until all sites are receiving the intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of eligible patientsPre- and post-implementation phase, up to 24 monthsThe primary outcome (the reach measurement) is the percentage of eligible patients assessed, advised, and referred based on predefined BMI scores.

Secondary

MeasureTime frameDescription
Change in referral uptakePre- and post-implementation phase, up to 24 monthsThe 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.

Countries

Hong Kong

Contacts

CONTACTWendy Lam, PhD
wwtlam@hku.hk+852 39179878
PRINCIPAL_INVESTIGATORWendy Lam, PhD

The University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026