Evaluating the feasibility and outcomes of implementing PanCareFollowUp Care as usual care in four European Countries: a prospective cohort study

Conditions: ate effects in survivors of childhood cancer.

Registration Number: NL-OMON21449

Lead Sponsor: Princess Máxima Center, Utrecht, the Netherlands

Brief Summary: Results of the cohort study will be published in peer-reviewed journals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 800

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>2. Clinical outcomes<br>3. Health economic outcomes<br>4. Feasibility outcomes<br>