Building on previous research that shows the benefits of exercise, this study aims to find out how best to implement exercise in real-world settings. The study will assess the feasibility and acceptability of an embedding an automated referral tool and an exercise professional into standard cancer care impacts clinician referral and patient uptake of exercise programming. The study will assess how effective the exercise program is at improving patients' physical health, quality of life, symptom management, and overall wellbeing during different stages of their cancer journey (e.g., before treatment, on treatment, after treatment).
The ICARE study is a comprehensive hybrid Type 3 effectiveness-implementation trial aimed at evaluating the integration of an evidence-based exercise program into routine cancer care in real-world clinical settings. Its primary focus is on understanding the feasibility, acceptability, and practical aspects of implementing this intervention through the application of targeted implementation strategies, including the automation of referrals into the clinical workflow to streamline and standardize the process. Specifically, the study assesses the extent of program adoption at multiple levels: first, at the clinician level by measuring the proportion and representativeness of oncology care providers who refer patients to the exercise program; second, at the clinic level by evaluating the proportion and diversity of cancer centers and community clinics that successfully incorporate the exercise intervention into their standard workflows; and third, at the patient level by examining the reach of the program, including the number, proportion, and demographic diversity of participating patients. The study also seeks to identify contextual factors, such as organizational culture, resources, and clinician attitudes, as well as barriers and facilitators that influence successful implementation and sustainment of the program. While the primary focus is on implementation, the study also has a secondary aim to evaluate the clinical effectiveness of the tailored, evidence-based exercise intervention on important patient-centered outcomes. These include improvements in physical functioning, enhancements in quality of life, better symptom management, and overall wellbeing, measured across various stages of the post-diagnosis cancer journey (i.e., pretreatment/prehabilitation, active treatment, post-treatment/rehabilitation/early survivorship. Ultimately, the findings from this study aim to inform future implementation strategies, optimize integration processes, and improve patient outcomes by translating evidence-based practices into sustainable, real-world cancer care settings.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
500
PRE-TREATMENT: Frequency: 2-3 supervised exercise sessions/week (45-60 min/session) with 30 minutes of walking on non-supervised days. Intensity: Rating of Perceived Exertion (RPE) 5-7/10. Type: Multimodal (aerobic + resistance training). Time: 3 to 12 weeks of supervised exercise. ON TREATMENT: Frequency: 2 supervised exercise sessions/week (45-60 min/session) with 30 minutes of walking on non-supervised days. Intensity: RPE 3-5/10. Type: Multimodal (aerobic + resistance training). Time: 12 weeks of supervised exercise. POST-TREATMENT: Frequency: 3 supervised exercise sessions/week (45-60 min/session) for the first 4 weeks; 2 supervised + 1 independent exercise sessions per week for the next 4 weeks; 1 supervised + 2 independent exercise session for the next 4 weeks; 3 independent exercise sessions for the final 4 weeks + 30 minutes of walking on non-supervised days. Intensity: RPE 5-7/10. Type: Multimodal (aerobic + resistance training). Time: 16 weeks tapered exercise program.
Physical Activity & Cancer Lab
Halifax, Nova Scotia, Canada
Implementation [Reach]
Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, Reach will be assessed across each intervention phase by tracking participant accrual (number of consenting participants divided by the number of referrals) and by monitoring the representativeness of consenting participants by comparing demographic and relevant characteristics (i.e., age, ethnicity, socioeconomic status, and disease status) of the sample against the broader target population. Reasons for study refusal will also be documented.
Time frame: 12 months, 24 months, 36 months
Implementation [Adoption]
Guided by the RE-AIM framework Adoption will be examined across each intervention phase by documenting the total number of clinician referrals received annually as well as the characteristics of referring clinicians, including their roles (e.g., oncologist, oncology nurse, nurse navigator). A representative sample of non-referring clinicians will be interviewed to explore any underlying psychological and/or environmental barriers/facilitators to referring patients to exercise programming.
Time frame: 12 months, 24 months, 36 months
Implementation Outcomes
Guided by the RE-AIM framework, Implementation outcomes will be assessed across each intervention phase and will include feasibility (i.e., intervention adherence, consent, refusal, and completion rates, percentage of missing data), acceptability (semi-structured interviews with a representative sub-sample of patients who decline participation, consent to participate, and those who complete or withdraw prematurely from the study), and fidelity of intervention protocol delivery (i.e., adherence to exercise prescription, and program components; quality of instructor delivery; participant engagement and responsiveness to home-based walking).
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Implementation [Maintenance]
Guided by the RE-AIM framework Maintenance will be assessed across each intervention phase by evaluating the sustainability of exercise practices at the organizational and individual levels over time. Data collection will include quantitative metrics (e.g., referral rates, completion rates) and qualitative interviews with stakeholders to explore contextual facilitators and barriers.
Time frame: 12 months, 24 months, 36 months
Implementation [Cost Effectiveness]
The EQ-5D-5L (EuroQol 5-Dimension, 5-Level questionnaire) will be used to examine the cost effectiveness across each intervention phase (pre-treatment, active treatment, post-treatment). The EQ-5D-5L measures five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) of health on a 5-point scale (1=no problems - 5=extreme problems). Responses are translated to a Health Utility Index (1=perfect health; 0=deceased). To measure cost-effectiveness, the utility score is plotted against time (Quality Adjusted Life Years = Time (years) x Health Utility Index).
Time frame: 36 months
Effectiveness [Quality of Life]
Quality of life will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, version 3.0). The EORTC assesses five functional domains (physical, role, cognitive, emotional, social), three symptom scales (fatigue, pain, nausea/vomiting), six individual symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, financial impact), and a two-item global health and quality of life scale, with most items rated on a 4-point Likert scale and global scales on a 7-point scale; higher scores indicate better functioning and health for functional and global scales, but greater symptom burden for symptom scales.
Time frame: Baseline, 12 weeks, 16 weeks
Effectiveness [Physical Activity]
Self-reported physical activity will be measured using the modified Godin Leisure-Time Exercise Questionnaire, where participants recall their activity over the past week across three intensity levels (strenuous, moderate, mild), including frequency and session duration. Total weekly moderate-to-vigorous physical activity (MVPA) will be calculated by summing minutes from moderate and strenuous activities, and a Leisure Time Physical Activity (LTPA) score will be derived by multiplying weekly strenuous exercise by 9 and moderate exercise by 5; scores of 24 or higher indicate sufficient activity, while scores of 23 or lower indicate insufficient activity.
Time frame: Baseline, 12 weeks, 16 weeks
Effectiveness [Symptom Burden]
The Edmonton Symptom Assessment System (ESAS-r) will be used to evaluate symptom burden over the past 24 hours, measuring nine core symptoms (pain, tiredness, drowsiness, nausea, appetite loss, shortness of breath, depression, anxiety, overall well-being) plus an open-ended item for additional symptoms, with each scored from 0 (none or best) to 10 (worst), and symptom severity categorized as mild (1-3), moderate (4-6), or severe (7-10).
Time frame: Baseline, 12 weeks, 16 weeks
Effectiveness [Participant Satisfaction]
Participant satisfaction and program acceptability will be assessed using a 10-item self-report questionnaire. The questionnaire covers five domains: Program \& Staff Experience, Group Dynamics \& Social Support, Perceived Benefits, Program Burden \& Feasibility, and Future Intent \& Overall Satisfaction, with two items each. All items are rated on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree), and total scores (ranging from 10 to 50) indicate higher acceptability.
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Time frame: 12 weeks, 16 weeks
Effectiveness [Physical Fitness]
Fitness assessments will include evaluating upper body strength and endurance (modified push-up), lower body strength and endurance (30-second sit-to-stand), balance (Single Leg Stance Test), and aerobic capacity (2-minute step test).
Time frame: Baseline, 12 weeks, 16 weeks
Effectiveness [Functional Capacity]
Functional capacity will be assessed using the ECOG Performance Status Scale, which ranges from 0 (fully active) to 5 (deceased). The scale categorizes participants based on their daily physical restrictions, from full activity with no restrictions (Grade 0) to limited self-care and significant disability (Grade 3), total assistance (Grade 4).
Time frame: Baseline, 12 weeks
Effectiveness [Treatment Related Complications]
Treatment-related complications will be documented using the Common Terminology Criteria for Adverse Events (CTCAE) - a standardized classification system used to identify and grade the severity of adverse events graded from 1 (mild) to 5 (life-threatening - death).
Time frame: Baseline, 12 weeks