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Not yet recruiting NCT07210905

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

No phase Interventional Exercise Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3-step Assess-Advice-Refer.
Who it may be relevant to
Registry conditions: Exercise, Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

  • 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 appropriate

Primary outcome measures

  • Percentage of eligible patients [Time frame: Pre- and post-implementation phase, up to 24 months]
Secondary outcome measures (1)
  • Change in referral uptake [Time frame: Pre- and post-implementation phase, up to 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Health services research

Study locations

Hong Kong · 8 centers
  • KWH Department of Surgery — Hong Kong
  • PMH Department of Oncology — Hong Kong
  • PYEH Department of Clinical Oncology — Hong Kong
  • QMH Department of Clinical Oncology — Hong Kong
  • QMH Department of Obstetrics and Gynaecology — Hong Kong
  • QMH Department of Surgery — Hong Kong
  • TMH Department of clinical oncology — Hong Kong
  • YCH Surgery Department — Hong Kong

Identifiers

NCT: NCT07210905 · UW 24-572

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗