Supervised 16-Week Multicomponent Exercise Training Programme for 18-55-Year-Old People Living with and Beyond Cancer-CONSORT 2025-Based Study Protocol of the Pilot Onco-Move Randomized Controlled Trial.

The Onco-Move RCT will enroll 40 participants with cancer who will be randomly assigned to experimental or control groups.

• Participants must be aged 18-55 years and currently undergoing cancer treatment or up to 5 years post-treatment.
• The trial accepts participants with different types of cancer.
• Participants will be randomly assigned to either the experimental or the control group.
• The study is described as a pilot randomized controlled trial.

The exercise intervention consists of a supervised multicomponent programme delivered three times per week for 16 weeks.

• The programme runs for 16 weeks with sessions three times per week.
• The overall study duration is 7 months, encompassing the exercise programme and follow-up assessments.
• The programme is described as 'supervised' and 'multicomponent' in nature.
• The intervention is intended to be feasible for implementation in oncological NGOs and hospitals in Poland and Spain.

Most people living with and beyond cancer (PLWBC) are insufficiently physically active despite evidence that exercise improves treatment outcomes.

• This gap between evidence and practice motivates the development of the Onco-Move programme.
• The study addresses PLWBC as a distinct population requiring targeted exercise interventions.
• The programme is described as a 'non-pharmacological aid for cancer patients and survivors.'

The study hypothesizes that the Onco-Move exercise programme will improve quality of life, sexual function, and stress-response strategies in PLWBC.

• Quality of life is listed as a primary outcome of interest.
• Sexual function is included as a hypothesis-driven outcome, which is notable for this age group (18-55 years).
• Stress-response strategies are also included as a hypothesized outcome.
• The protocol is CONSORT 2025-based, indicating adherence to updated reporting standards for RCTs.

The study hypothesizes that the exercise programme will produce improvements in nutrition, physical functions, and body composition.

• Physical functions and body composition are listed among the expected outcomes.
• Nutritional status is included as an outcome measure alongside physical outcomes.
• These outcomes are expected to result from the 16-week multicomponent exercise intervention.

The protocol anticipates observing physiological biomarker changes related to inflammation, metabolism, muscle adaptation, and cellular aging.

• Biomarkers of inflammation are included as expected physiological outcomes.
• Metabolic biomarkers are listed alongside markers of muscle adaptation.
• Cellular aging biomarkers are also included, suggesting assessment of molecular-level responses to exercise.
• These physiological outcomes represent the mechanistic component of the intervention study.

The Onco-Move programme is intended for future implementation in oncological NGOs and hospitals in Poland and Spain once validated.

• The programme is described as having 'potential to be implemented in oncological non-governmental organizations (NGOs) and hospitals in Poland and Spain, among others.'
• Implementation feasibility, effectiveness, and safety are cited as criteria for broader adoption.
• The pilot nature of the trial is explicitly designed to validate the programme prior to wider implementation.