About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have received a cancer diagnosis (inclusive of primary, recurrent; and/or metastatic disease);
Over the age of 19 years;
Able to participate in mild levels of activity as a minimum;
Be pretreatment, or receiving active cancer treatment, or have received cancer treatment within the past six months and are still under active oncology care, or beyond six months if they continue to be under active oncology care;
Disqualifiers
Severe cognitive, physical, psychiatric, or uncontrolled medical condition(s) resulting in an inability to provide consent and/or safely participate in the study.
Trial design
Parallel
Treatments tested in this trial
Exercise
Other interventionPRE-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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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).
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.
Secondary outcomes
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.
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.
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).
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.
Sponsors and contacts
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Melanie Keats
Lead sponsor
Nova Scotia Health Authority
Sponsor institution
Queen Elizabeth II Health Sciences Centre
Collaborator
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