The Physical Activity and fitness in Childhood Cancer Survivors (PACCS) study: Rationale and study design of an international study (Preprint)

BACKGROUND The Physical Activity in Childhood Cancer Survivors (PACCS) study consists of four work packages (WPs) aiming for objective determination of PA, and self-reported health behaviour, fatigue and quality of life (QoL) (WP 1), physical fitness (WP 2), evaluation of barriers/facilitators to PA (WP 1 and 3) and the feasibility testing of an intervention to increase PA and physical fitness (WP 4) based on the previous WPs. OBJECTIVE The Physical Activity in Childhood Cancer Survivors (PACCS) study consists of four work packages (WPs) aiming for objective determination of PA, and self-reported barriers to PA, health behaviour, fatigue and quality of life (QoL) (WP 1), physical fitness (WP 2), evaluation of barriers/facilitators to PA (WP 3) and feasibility testing of an intervention to increase PA and physical fitness (WP 4) based on the previous WPs. METHODS The PACCS study will use a mixed-method design, combining patient-reported outcome measures and objective clinical and physiological assessments with qualitative data gathering methods. A total of 500 CCS aged 9-18 years of age, >1 year after completed treatment will be recruited in follow-up care clinics in Norway, Denmark, Finland, Germany and Switzerland. All participants will participate in WP 1, of these about 150 will be recruited to WP 2, about 40 to WP 3, and about 30 to WP 4. Reference material for WP 1 is available from existing studies, while WP 2 will recruit healthy controls. PA levels will be measured using ActiGraph accelerometers and self-report. Validated questionnaires will be used to assess health behaviors, fatigue, and QoL. Physical fitness will be measured by a cardiopulmonary exercise test (VO2peak), isometric muscle strength tests (hand grip, knee extension and chest press), muscle power test (counter-movement jump) and muscle-endurance test (1-min Sit-to-Stand). Limiting factors will be identified by neurological, pulmonary, and cardiac evaluations, and assessment of body composition and muscle size. Semi-structured, qualitative interviews, analysed using systematic text condensation, will identify CCS and parents perceived barriers/facilitators of PA. In WP 4, we will evaluate the feasibility of a 6-month personalized PA intervention with the involvement of local structures. RESULTS The PACCS study will generate high-quality knowledge that will contribute to the development of an evidence-based PA intervention for young CCS to improve their long-term care and health. Further, we will identify physiological, psychological, and social barriers to PA that can be targeted in future PA interventions. This will allow for rapid and cost-effective implementation of such a service with immediate benefits to the young CCS in need of rehabilitation. CONCLUSIONS The PACCS study will generate high-quality knowledge that will contribute to the development of an evidence-based PA intervention for young CCS to improve their long-term care and health. Further, we will identify physiological, psychological, and social barriers to PA that can be targeted in future PA interventions. This will allow for rapid and cost-effective implementation of such a service with immediate benefits to the young CCS in need of rehabilitation. CLINICALTRIAL Not applicable