From Exercise Oncology Research to Clinical Practice (PAC ICare)

Experimental: Pre-treatment (Prehabilitation)

Participants preparing for surgery, a minimum 3-week prehabilitation intervention will be implemented to optimize physical functioning prior to the surgical procedure. Supervised exercise sessions will be delivered 2-3 times per week throughout the pre-surgical intervention, with participants encouraged to engage in 30 minutes of walking on non-supervised days. Individuals undergoing neoadjuvant therapy will continue participating in the exercise program up to the date of surgery, up to a maximum duration of 12 weeks of supervised exercise programming.

Otro: Exercise

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.

Experimental: Active Treatment

Participants receiving adjuvant therapy who are not scheduled for surgery, as well as those who have recovered from surgery, will be enrolled in a 12-week exercise intervention. Supervised sessions will be delivered 2 times per week and an independent walking program of 30 minutes/day on non-supervised exercise days will be encouraged.

Otro: Exercise

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.

Experimental: Post-Treatment (Rehabilitation/Early Survivorship)

Participants who have completed treatment will engage in a progressively tapered exercise program. This program will involve supervised sessions 3 times per week during the initial four weeks, followed by 2 sessions per week for the subsequent four weeks, and 1 session per week for the remaining 12 weeks. Participants will be encouraged to walk 30 minutes/day on non-supervised exercise days. The final four weeks will emphasize the transition toward independent exercise participation, incorporating self-monitoring strategies and mid-month (week 14) check-in to address any emerging concerns and support appropriate adjustments to the program.

Otro: Exercise

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.

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.

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).

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.

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).

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).

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).