Table 1 Outcome measures at each time point with time required for completion
Domain/Measure | Time Required for Completion | Baseline (month 0;T0) | Mid-point (month 3; T1) | Post-intervention (month 6; T2) | 6-month follow-up (month 12; T3) | 1-year follow-up (month 18; T4) |
|---|---|---|---|---|---|---|
Eligibility | X | |||||
Informed consent | X | |||||
Group allocation (after completion of baseline, T0) | X | |||||
Interventions | ||||||
Intervention Group - Physical Activity + Behavioral Counseling Group (PA + BC) |
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Attention Control Group - Physical Activity + Exercise Counseling Group (PA + EC) |
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Measures | ||||||
Primary outcome | ||||||
Physical activity (ActiGraph accelerometers) | Worn for 7 days during waking hours only | X | X | X | X | X |
Secondary outcomes | ||||||
Quality of life (Functional Assessment of Cancer Therapy [FACT]-General, FACT-Fatigue, Fatigue subscale, EuroQol-5D) | 20 min | X | X | X | X | X |
Measures from the Multi-process Action Control (M-PAC) framework (affective attitudes, instrumental attitudes, injunctive norms, descriptive norms, and perceived control, behavioral regulation for physical activity, physical activity habits, exercise identity) | 15 min | X | X | X | X | X |
Physical function (i.e., 30-second chair stand, 6-minute walk test) | 30 min | X | X | X | X | X |
Demographic, medical and health history questionnaire | 10 min | X | ||||
Health economics (Health Services Utilization Inventory, iMTA Productivity Cost Questionnaire, Incremental Cost of Intervention) | 20 min | X | X | X | X | X |
Participant satisfaction questionnaire | 5 min | X | ||||
Adherence and compliance (Physical activity log) | 5 min | assessed throughout intervention | ||||
Fidelity and quality control (Fidelity checklists) | 5 min | assessed throughout intervention | ||||
Adverse events (Adverse events log) | 5 min | assessed throughout intervention | ||||
