PCSP Implementation Study

NCT05982587 | Unknown

• 1 other identifier: N.CET-Liguria:265-2023-DB13200
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Survivorship; Late Effect

Outcome Measures

Primary Outcomes (1)

• Study of activation after the delivery of the personal SurPass v2.0

  The change in levels of activation after the delivery of the personal SurPass v2.0. Activation will be measured using the validated Patient Activation Measure (PAM). This instrument is a Likert type questionnaire in which respondent score each item with their level of agreement ranging from 1 (strongly disagree) to 4 (strongly agree). In case of the item is not applicable, no score is provided and marked in a specific section.

  Before (2-8 weeks) and after (2-3 months) SurPass delivery

Secondary Outcomes (5)

• Study of empowerment after the delivery of the personal SurPass v2.0

  Before (2-8 weeks) and after (2-3 months) SurPass delivery

• Study of CCS quality of life

  Before (2-8 weeks) and after (2-3 months) SurPass delivery

• Study of satisfaction of HCPs and CCS with the digital SurPass tool

  At SurPass delivery and after (2-3 months)

• Study of emotional impact after the delivery of the personal SurPass v2.0

  After (2-3 months) SurPass delivery

• Study of economical impact after the delivery of the personal SurPass v2.0

  Imp-Cost questionnaire: baseline at SurPass delivery. Op-Cost: immediately after SurPass delivery. CCS Cost Qx: within 3 months after SurPass delivery.

Interventions

Survivorship passport (SurPass) delivery OTHER

The Survivorship Passport (SurPass) is a digital tool developed thanks to several EU projects to help Childhood Cancer Survivors (CCS), their families and health care providers (HCPs) in the follow-up process after completion of anticancer treatment. It comprises two main components: Treatment Summary including demographic, diagnosis and treatment data and personalized Survivorship Care Plan providing individual follow-up care recommendations The SurPass assists both CCS and HCPs to improve Long-Term Follow-Up care, in a partnership, supporting CCS empowerment and satisfaction with care, as well as shared decision-making by CCS and HCPs. The aim of the PCSP implementation study is to evaluate feasibility and outcomes (personal and economic) of implementing the SurPass v2.0 in six clinics located in Austria, Belgium, Germany, Italy, Lithuania and Spain by using interoperability procedures according to Health Level 7- Fast Healthcare Interoperability Resource (HL7-FHIR) standards.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead

Study Sites (1)

Istituto Giannina Gaslini

Genoa, 16147, Italy

Location

Related Publications (5)

• Haupt R, Spinetta JJ, Ban I, Barr RD, Beck JD, Byrne J, Calaminus G, Coenen E, Chesler M, D'Angio GJ, Eiser C, Feldges A, Gibson F, Lackner H, Masera G, Massimo L, Magyarosy E, Otten J, Reaman G, Valsecchi MG, Veerman AJ, Penn A, Thorvildsen A, van den Bos C, Jankovic M; International Berlin-Frankfurt-Munster Study Group Early and Late Toxicity Educational Committee (I-BFM-SG ELTEC). Long term survivors of childhood cancer: cure and care. The Erice statement. Eur J Cancer. 2007 Aug;43(12):1778-80. doi: 10.1016/j.ejca.2007.04.015. Epub 2007 May 31.

  PMID: 17543517 BACKGROUND

• Jankovic M, Haupt R, Spinetta JJ, Beck JD, Byrne J, Calaminus G, Lackner H, Biondi A, Oeffinger K, Hudson M, Skinner R, Reaman G, van der Pal H, Kremer L, den Hartogh J, Michel G, Frey E, Bardi E, Hawkins M, Rizvi K, Terenziani M, Valsecchi MG, Bode G, Jenney M, de Vathaire F, Garwicz S, Levitt GA, Grabow D, Kuehni CE, Schrappe M, Hjorth L; participants in PanCare. Long-term survivors of childhood cancer: cure and care-the Erice Statement (2006) revised after 10 years (2016). J Cancer Surviv. 2018 Oct;12(5):647-650. doi: 10.1007/s11764-018-0701-0. Epub 2018 Jun 26.

  PMID: 29946794 BACKGROUND

• Haupt R, Essiaf S, Dellacasa C, Ronckers CM, Caruso S, Sugden E, Zadravec Zaletel L, Muraca M, Morsellino V, Kienesberger A, Blondeel A, Saraceno D, Ortali M, Kremer LCM, Skinner R, Roganovic J, Bagnasco F, Levitt GA, De Rosa M, Schrappe M, Hjorth L, Ladenstein R; PanCareSurFup, ENCCA Working Group; ExPo-r-Net Working Group. The 'Survivorship Passport' for childhood cancer survivors. Eur J Cancer. 2018 Oct;102:69-81. doi: 10.1016/j.ejca.2018.07.006. Epub 2018 Aug 20.

  PMID: 30138773 BACKGROUND

• van Kalsbeek RJ, Mulder RL, Haupt R, Muraca M, Hjorth L, Follin C, Kepak T, Kepakova K, Uyttebroeck A, Mangelschots M, Winther JF, Loonen JJ, Michel G, Bardi E, Elmerdahl Frederiksen L, den Hartogh J, Mader L, Roser K, Schneider C, Brown MC, Brunhofer M, Gottgens I, Hermens RPMG, Kienesberger A, Korevaar JC, Skinner R, van der Pal HJH, Kremer LCM. The PanCareFollowUp Care Intervention: A European harmonised approach to person-centred guideline-based survivorship care after childhood, adolescent and young adult cancer. Eur J Cancer. 2022 Feb;162:34-44. doi: 10.1016/j.ejca.2021.10.035. Epub 2021 Dec 22.

  PMID: 34953441 BACKGROUND

• van Kalsbeek RJ, van der Pal HJH, Kremer LCM, Bardi E, Brown MC, Effeney R, Winther JF, Follin C, den Hartogh J, Haupt R, Hjorth L, Kepak T, Kepakova K, Levitt G, Loonen JJ, Mangelschots M, Muraca M, Renard M, Sabic H, Schneider CU, Uyttebroeck A, Skinner R, Mulder RL. European PanCareFollowUp Recommendations for surveillance of late effects of childhood, adolescent, and young adult cancer. Eur J Cancer. 2021 Sep;154:316-328. doi: 10.1016/j.ejca.2021.06.004. Epub 2021 Jul 29.

  PMID: 34333209 BACKGROUND

MeSH Terms

Interventions

Calcium Carbonate; Parturition

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Central Study Contacts

Monica Muraca, MD

CONTACT

01056363462; monicamuraca@gaslini.org

Francesca Bagnasco

CONTACT

francescabagnasco@gaslini.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 8, 2023
• Study Start: August 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: February 28, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)