Cancer survivor
Conditions
Interventions
Group 1: Needs-adapted intensified interventions in the fields of sport and physical
activity, nutrition, and psychooncology with individual consultations and examinations at the study sites and throu
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
15 Years to 39 Years
Inclusion criteria
Inclusion criteria: - Young patients with a hemato-oncological disease in childhood, adolescence and young adult age, who have completed tumor therapy, are in follow-up care, and are currently tumor free - age 15 to 39 years - written informed consent (patients below age of 18 years written informed consent by both parents)
Exclusion criteria
Exclusion criteria: Serious underlying medical conditions that could impair the ability of the patient to participate in the trial (e.g. manifest psychiatric disorder)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall study Modular interventions - Rate of CAYAs (children, adolescents, and young adults) with high need for interventions after 12 months (comparison Interventional and control group in randomized study part) Needs assessment (Co-primary Endpoint) - Rate of CAYAs with needs not yet characterized in the needs assessment ("unmet needs") Modular interventions 1) Sport and physical activities: Increase in physical activity 2) Nutrition: Improvement of nutritional habits 3) Psychooncology: Increasing Patient Competence | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall study 1) Feasability: Rate of etablishment of the program at the sites (conditions regarding the site, personnel, implementation of the program); Monthly rate of inclusion at the sites; Rate of complete questionnaires at needs assessment; Rate of complete medical and clinical diagnostics; Rate of remaining CAYAs in the program (at least 2 needs assessments) in relation to participation in interventional modules; Practicability of adaptions of needs assessment (time between evaluation of data, protocol amendment, approval of ethics committee and implementation in the program); Drop-out-Rates (relating study and single interventions) 2) Cost-efficiency: Cost efficiency (secondary costs, health economy and -management, health care utilization) 3) Allocation and effectiveness of modular Interventions: Changes in needs after 12 months in relation to initial needs and participation in interventional modul; Prevalence of cardiovascular risk factors (BMI, WHR, blood sugar-/fat metabolism disorders, hypertension); Quality of life and fatigue // Modular interventions 1) Sport and physical activity: Increase regular physical activity to at least 3 days per week with a total of >150 minutes/week of moderate physical activity and/or >75 minutes of vigorous physical activity; reduction in situational and exercise-related barriers; improvement in quality of life and fatigue; 5% improvement in phase angle compared with baseline measurement; improvement in endurance capacity (Hamburg site only). 2) Nutrition: Improvement in phase angle by 5% compared to baseline; improvement in Mediterranean dietary behavior; reduction in the number of patients who are underweight, overweight, or obese by BMI compared to baseline; reduction in diet-related barriers; improvement in quality of life and fatigue; improvement in subjective and objective taste perceptions (Hamburg site only). 3) Psychooncology: Increase in self-efficacy experience; reduction in depression; reduction in dist | — |
Countries
Germany
Contacts
Public ContactCARE for CAYA-Team
Hubertus Wald Tumorzentrum, Universitäres Cancer Center Hamburg, Universitätsklinikum Hamburg-Eppendorf (UKE), O43
Outcome results
None listed