Clinical trial NCT05982587: PCSP Implementation Study
Official title: PanCareSurPass (PCSP) Conduct and Analysis of the Multi-country Implementation Study of the SurPass v2.0
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Survivorship
Late Effect
Lead sponsor: Istituto Giannina Gaslini
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 360
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Within this study we'll enroll childhood cancer survivors (CCS), defined as those subjects who have survived ≥5 years since diagnosis.

Compared to the general population, CCS represent a vulnerable population being at increased risk of developing psychosocial and health problems known as late effects, resulting in low quality of life, excess morbidity and mortality

Brief summary: This study protocol describes the design and methods of the PanCareSurPass (PCSP) multi-country implementation study of the Survivorship Passport v2.0 (short: PCSP implementation study), which is part of the PCSP project that has received funding through the European Union (EU) Horizon 2020 Programme. The cohort study will inform researchers and stakeholders on the process and outcomes of implementing the Survivorship Passport (SurPass) v2.0 in the Electronic Health Information Systems (EHIS) of six clinics in the EU countries Austria (CCRI), Belgium (KU Leuven), Germany (UMC-Mainz/UzL), Italy (IGG), Lithuania (VULSK) and Spain (HULAFE).

The SurPass comprises two main components, the Treatment Summary (TS) including demographic, diagnosis and treatment data and the personalized Survivorship Care Plan (SCP) including individual follow-up care recommendations. The SCP is based on internationally approved, organ-specific follow-up care recommendations.

The SurPass is used as a tool to assist both Childhood Cancer Survivors (CCS) and Health Care Providers (HCPs) to improve Long-Term Follow-Up (LTFU) care, in a care partnership, supporting CCS empowerment and satisfaction with care, as well as shared decision-making by CCS and HCPs. People-centred care is important in CCS since they are a vulnerable population known to be at higher risk of developing chronic conditions as compared to their peers in the general population.

The overall aim of the cohort study is to evaluate the implementation of the SurPass v2.0 in the six centres by testing the feasibility of test wise implementation of the SurPass v2.0 in different health system scenarios and assessing the people-centred LTFU care for CCS with the SurPass as a tool and the cost effectiveness. Six long term follow-up clinics across Europe will enrol eligible, consented CCS and generate personalised digital SurPass. Eligible participants for the main study cohort will be CCS more than 5 years after diagnosis and with an identified treatment burden based on actual exposure to respective treatments (Cumulative Treatment Doses (CTD) of chemotherapy, immunotherapy, radiotherapy). In preparation of the clinic visit, HCPs/local data monitors will use the SurPass v2.0 platform to generate the TS (semi-automated or manual data entry) from which, in turn, the preliminary SCP is automatically created using the built-in algorithms for each consented survivor.

During the clinic visit the preliminary SCP is discussed with the Survivor, and tailored to meet the CCS personal needs and a final SCP will be generated. The SCP will include detailed country-specific recommendations, where applicable. The SurPass v2.0 (TS + SCP) will then be integrated into the institutional EHIS, as well as in the survivor's national/regional Electronic Health Platform (EHP) where available.

CCS who give informed consent will complete (online) study questionnaires at two measuring points: before the visit to the clinic, and after they received the SurPass during the clinical visit. HCPs will also provide study data: the TS which went into the SurPass (clinical data) and data to monitor the implementation and assess the barriers and facilitators of implementing the SurPass. In addition, data will be collected from both survivors and health care providers to assess the cost-effectiveness of implementing the SurPass.

Regarding the outcome evaluation, the main outcome is the change in levels of activation of survivor or caregiver, as assessed using the Patient Activation Measure (PAM) prior and after clinic visit. Further measurements will be made related to: empowerment, satisfaction with the digital SurPass tool, emotional impacts, quality of life and additional costs of CCS.

The main outcome will be analysed by multivariable logistic regression. Analysis for the secondary outcomes will be mostly descriptive. The economic assessment will be analysed by cost analysis, cost utility analysis and multi-criteria decision analysis.

The study will be conducted in accordance with the guidelines of good clinical practice (ICH/GCP) and the Helsinki Declaration. The investigators will carefully address all ethical, legal and safety aspects of the study and fully comply with prevailing national and EU regulations and legislation.


Eligibility criteria: Inclusion Criteria:

* being diagnosed with cancer before the age of 18 years;
* have completed the planned treatment protocol;
* being still in continuous, complete remission at least five years from primary cancer diagnosis (≥5 years survivorship);
* being in follow-up care at one of the institutions participating in the study;
* have signed informed consent/assent to the study according to local legislation.

Exclusion Criteria:

* currently in treatment for secondary malignancy or relapse of primary malignancy;
* have already received previous versions of the SurPass (v1.0 - 1.2).

Primary outcomes:
measure: Study of activation after the delivery of the personal SurPass v2.0
timeFrame: Before (2-8 weeks) and after (2-3 months) SurPass delivery
Secondary outcomes:
measure: Study of empowerment after the delivery of the personal SurPass v2.0
timeFrame: Before (2-8 weeks) and after (2-3 months) SurPass delivery
measure: Study of CCS quality of life
timeFrame: Before (2-8 weeks) and after (2-3 months) SurPass delivery
measure: Study of satisfaction of HCPs and CCS with the digital SurPass tool
timeFrame: At SurPass delivery and after (2-3 months)
measure: Study of emotional impact after the delivery of the personal SurPass v2.0
timeFrame: After (2-3 months) SurPass delivery
measure: Study of economical impact after the delivery of the personal SurPass v2.0
timeFrame: Imp-Cost questionnaire: baseline at SurPass delivery. Op-Cost: immediately after SurPass delivery. CCS Cost Qx: within 3 months after SurPass delivery.
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: Istituto Giannina Gaslini
Study officials:
References:
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