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

NCT07210905 | Not Yet Recruiting

• 1 other identifier: UW 24-572
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 8

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.

Conditions

Exercise; Cancer

Keywords

Implementation study; Weight management; Cancer survivorship

Outcome Measures

Primary Outcomes (1)

• Percentage of eligible patients

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

  Pre- and post-implementation phase, up to 24 months

Secondary Outcomes (1)

• Change in referral uptake

  Pre- and post-implementation phase, up to 24 months

Study Arms (2)

Implementation condition

EXPERIMENTAL

Under implementation conditions, the FitARise protocol will be implemented in routine oncological clinics using 4 implementation strategies, including audit, feedback, facilitation, and adaptable workflow at the beginning of the study.

Behavioral: 3-step Assess-Advice-Refer

Control condition

NO INTERVENTION

In the control condition, the clinical outpatient operation is performed as usual. The screening tool and referral forms will be provided to the study sites and clinicians are encouraged eligible patients to adopt the FitARise program. Patients referred to JCICC will be managed following the predefined clinical pathway triage system. A briefing session about the purpose of the implementation program and the introduction of the FitARise protocol will be given to the staff at each study unit before the start of the first 4-months control condition. The briefing session will be recorded for the purpose of fidelity assessment.

Interventions

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.

Also known as: FitARise

Implementation condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have completed cancer treatments for more than five years;
• Non-Cantonese, non-Mandarin, non-English speakers.
• \- All clinical, medical or surgical oncologists at the study units during the study period.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (8)

KWH Department of Surgery

Hong Kong, Hong Kong

Location

PMH Department of Oncology

Hong Kong, Hong Kong

Location

PYEH Department of Clinical Oncology

Hong Kong, Hong Kong

Location

QMH Department of Clinical Oncology

Hong Kong, Hong Kong

Location

QMH Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong

Location

QMH Department of Surgery

Hong Kong, Hong Kong

Location

TMH Department of clinical oncology

Hong Kong, Hong Kong

Location

YCH Surgery Department

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Motor Activity; Neoplasms

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Wendy Lam, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Lam, PhD

CONTACT

+852 39179878; wwtlam@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 7, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication
• Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.

Locations

HK (8)