A new study is evaluating the effectiveness of structured, multidisciplinary long-term care for pediatric cancer survivors. The study, detailed in Trials Journal, aims to improve self-efficacy, satisfaction with healthcare, health-related quality of life (HRQoL), mental health, and readiness for transitioning to adult healthcare among young cancer survivors.
The study addresses a critical need for comprehensive follow-up care for pediatric cancer survivors, who often face long-term health challenges. The intervention involves a structured program delivered across ten pediatric university clinics, with a recruitment period of 24 months.
Primary Outcome: Self-Efficacy
The primary outcome is the self-efficacy of children and adolescents aged 12 years and older, as well as the self-efficacy of their parents. Self-efficacy is measured using an adaptation of the General Self-Efficacy Scale, a tool that assesses the extent to which individuals believe they can influence events in their lives and overcome obstacles. The scale consists of ten items rated on a four-point Likert scale. The questionnaire is modified to focus on health and healthcare contexts, with specific instructions asking participants to consider how well they manage situations related to these topics.
Secondary Outcomes
Several secondary outcomes are being assessed to provide a comprehensive evaluation of the intervention's impact:
- Satisfaction with Health Care: Assessed using the Health Care Satisfaction module from the Pediatric Quality of Life Inventory (PedsQL) for parents of children up to 18 years old. Patients aged 12 years and older complete an adaptation of the German short form of the Youth Health Care measure—Satisfaction, Utilization, and Needs (YHC-SUN).
- HRQoL: The core module from the PedsQL is used to evaluate HRQoL across four domains: physical, emotional, social, and school functioning. Parents provide proxy reports for children up to 18 years old, while individuals aged 12 and older complete self-reports.
- Mental Health Problems: Mental health issues are assessed using the German version of the Strengths and Difficulties Questionnaire (SDQ). Parents provide proxy reports for children up to 18 years old, and individuals aged 12 and older complete self-reports. The SDQ includes 25 items divided into 5 subscales: emotional symptoms, conduct problems, hyperactivity-inattention, peer relationship problems, and prosocial behavior.
- Transition Readiness: An adaptation of the Transition Readiness Assessment Questionnaire (TRAQ) GV 15 is used to assess a young person’s readiness to transition from pediatric to adult health care, with self-reports from 14 years onwards. This evaluates the ability to manage health care needs independently and communicate effectively with healthcare providers.
Sample Size and Recruitment
The study aims to include at least 160 participants from ten pediatric university clinics. The sample size calculation assumes a medium effect size (delta of 0.3) of the intervention on self-efficacy in parents, based on comparable studies. Accounting for a 10% loss to follow-up and an intra-cluster correlation (ICC) of 0.022, this sample size is designed to achieve a power of 80%. Each participating clinic is responsible for recruiting its own participants over a 24-month period. The study may extend the recruitment period if difficulties arise.
All questionnaires used to assess the primary and secondary endpoints have been validated for reliability and validity and are widely used in research and clinical settings. Sociodemographic data is also recorded in line with the population-based German KIGGS study.
