Late effects in survivors of childhood cancer.
Conditions
Interventions
PCFU Care is a person-centered care approach developed in the Netherlands to meet the needs of adult survivors of childhood cancer, of whom many experience (either physical or psychological) late effe
health care professionals prepare a Treatment summary. The use of these instruments belong to standardized PCFU Care. During and after the visit, additional diagnostic tests may be performed. A follow
Sponsors
Princess Máxima Center, Utrecht, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or older 2. Diagnosed with cancer before the age of 19 years 3. At least 5 years from cancer diagnosis 4. At least one year off-treatment (also applying to treatment of secondary tumours, benign tumours, skin cancers) 5. Treated with chemotherapy and/or radiation therapy for childhood cancer 6. Not having received complete follow-up care (as described in PCFU Intervention Manual) 7. Signed informed consent according to local legislation
Exclusion criteria
Exclusion criteria: 1. Being unable to answer the questions of the PCFU-Cohort study questionnaires (not even with help from another person) because of severe mental sequelae or insufficient mastery of language used. 2. Currently in treatment for secondary malignancy or relapse of primary malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Given the short study period and the expected variety in health-related outcomes, we have refrained from a health-related outcome as the primary outcome measure, and chosen instead a cognitive-behavioural patient-reported outcome, namely empowerment. The change in empowerment will be measured by the Health Education Impact Questionnaire (HEIQ) including 32 items and six constructs: social Integration and support, health service navigation, constructive attitudes and approaches, skill and technique acquisition, emotional distress, and self-monitoring and insight. This study has a before-after design, where each survivor serves as their own control. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-reported outcomes (PROs): resilience, patient satisfaction, health-related quality of life (HRQoL), several aspects of mental health, fatigue, pain, lifestyle factors (including physical activity, tobacco (smoking) consumption, alcohol consumption and drug use), social functioning, shared decision-making. 2. Clinical outcomes 3. Health economic outcomes 4. Feasibility outcomes | — |
Contacts
Public ContactLeontien Kremer
Princess Máxima Center
Outcome results
None listed