ExerciseNCT07210905
Implementation of the 3-steps Assess-Advise-Refer Exercise (FitARise) Protocol as a Standard Practice in Cancer Care
A study testing 3-step Assess-Advice-Refer in people with Exercise and Cancer, run by The University of Hong Kong at 8 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- 3-step Assess-Advice-Refer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 8 sitesHong Kong
- Study dates
- 2 Feb 2026to 2 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- All clinical, medical or surgical oncologists at the study units during the study period.
Who cannot join
- Patients who have completed cancer treatments for more than five years;
- Non-Cantonese, non-Mandarin, non-English speakers.
- No exclusion criterial for staff.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Hong Kong8 sites, 8 recruiting
- Recruiting
KWH Department of Surgery
Hong Kong
Oi Kwan, +852 35176107, cok702@ha.org.hk
- Recruiting
PMH Department of Oncology
Hong Kong
Tim Chung, tim.chung@ha.org.hk
Chui Yu Shum
- Recruiting
PYEH Department of Clinical Oncology
Hong Kong
Sung Inda Soong, +852 97194300, soongs@ha.org.hk
- Recruiting
QMH Department of Clinical Oncology
Hong Kong
Wing Lok Chan, +852 22553111, winglok@hku.hk
- Recruiting
QMH Department of Obstetrics and Gynaecology
Hong Kong
Karen Chan, kklchan@hku.hk
- Recruiting
QMH Department of Surgery
Hong Kong
Ava Kwong, +852 2255 4773, avakwong@hku.hk
- Recruiting
TMH Department of clinical oncology
Hong Kong
Wing Yan Tin, +852 24685088, twy382@ha.org.hk
- Recruiting
YCH Surgery Department
Hong Kong
Kwok Fai Cheung, +852 24178366, ckf675@ha.org.hk
About this study
Official 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
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.
Read the 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.
- Being tested
- 3-step Assess-Advice-Refer
- Keywords
- Implementation study, Weight management, Cancer survivorship
- Medical subject headings
- Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-step Assess-Advice-ReferBehavioural
Also called FitARise
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre- and post-implementation phase, up to 24 months
Secondary outcomes (1)
Change in referral uptake
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.
Measured: Pre- and post-implementation phase, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start2 Feb 2026
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Lam, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210905
- Sponsor's protocol ID
- UW 24-572
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available from the PI upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07210905
- Acronym / sponsor ID
- UW 24-572
- Keywords
- Implementation study, Weight management, Cancer survivorship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2028 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Implementation condition | Experimental | Behavioral: 3-step Assess-Advice-ReferUnder 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who have completed cancer treatments for more than five years;
- Non-Cantonese, non-Mandarin, non-English speakers.
- No exclusion criterial for staff.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-step Assess-Advice-ReferAlso: FitARiseFour 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. | Behavioural | Implementation condition |
Primary outcome
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.
1 secondary outcome
Change in referral uptake
Time frame: Pre- and post-implementation phase, up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available from the PI upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendy Lam, PhD principal investigator
The University of Hong Kong
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-step Assess-Advice-Refer in people with Exercise and Cancer, run by The University of Hong Kong at 8 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Lam, PhD (+852 39179878, wwtlam@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible patients (time frame: Pre- and post-implementation phase, up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.