SurvivorshipNCT05982587
PCSP Implementation Study
An observational study of Survivorship and Late Effect, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Survivorship, Late Effect
- What is being tested?
- Survivorship passport (SurPass) delivery
- How many people
- 360 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2023to 28 Feb 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- currently in treatment for secondary malignancy or relapse of primary malignancy;
- have already received previous versions of the SurPass (v1.0 - 1.2).
Trial locations and contacts
1 site in 1 country.
Francesca Bagnasco contact
About this study
Official title: PanCareSurPass (PCSP) Conduct and Analysis of the Multi-country Implementation Study of the SurPass v2.0
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.
Read more
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
- Being tested
- Survivorship passport (SurPass) delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship passport (SurPass) deliveryOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The change in levels of empowerment after the delivery of their personal SurPass v2.0. Empowerment will be measured using the validated Health Education Impact Questionnaire (heiQ) scale. 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).
Measured: Before (2-8 weeks) and after (2-3 months) SurPass delivery
Study of CCS quality of life
CCS quality of life will be measured using the EuroQoL-5 Dimension (EQ-5D) questionnaire. This instrument is a Likert type questionnaire in which respondent score each quality of life related item ranging from 1 (I have no problems) to 5 (I have major problems).
Measured: Before (2-8 weeks) and after (2-3 months) SurPass delivery
Study of satisfaction of HCPs and CCS with the digital SurPass tool
Satisfaction of HCPs and CCS with the digital SurPass tool (either incorporated in the institutional EHIS and/or in national/regional EHP (where available) will be assessed using the validated Technology Acceptance Model (TAM) scale.
This instrument is a Likert type questionnaire in which respondent score each item with their level of agreement ranging from 1 (strongly agree) to 7 (strongly disagree).
Measured: At SurPass delivery and after (2-3 months)
Study of emotional impact after the delivery of the personal SurPass v2.0
The emotional impact of the SurPass delivery on CCS daily life in terms of modifications in daily activities, anxiety related to possible late effects, change in quantity and quality of information regarding possible late effects. This outcome will be evaluated by means of an ad hoc Likert-type PanCareSurPass specific questionnaire (PCSP-Q).
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 not willing to respond to the specific item, no score is provided and marked in a specific section.
Measured: After (2-3 months) SurPass delivery
Study of economical impact after the delivery of the personal SurPass v2.0
Three different types of costs: (1) costs related to technological development, implementation of interfaces, process adaptations, and social innovation (Imp-Cost), (2) operational costs incurred by the health care providers (Op-Cost) and (3) additional costs of CCS (or their caregivers) regarding the clinical visit (CCS Cost Qx) will be measured using PanCareSurPass specific questionnaires.
Measured: Imp-Cost questionnaire: baseline at SurPass delivery. Op-Cost: immediately after SurPass delivery. CCS Cost Qx: within 3 months after SurPass delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Haupt, Istituto Giannina Gaslini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982587
- Sponsor's protocol ID
- N.CET-Liguria:265-2023-DB13200
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17543517Jankovic 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.
PubMed 29946794Haupt 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.
PubMed 30138773van 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.
PubMed 34953441van 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.
PubMed 34333209
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PanCareSurPass (PCSP) Conduct and Analysis of the Multi-country Implementation Study of the SurPass v2.0
- ClinicalTrials.gov ID
- NCT05982587
- Acronym / sponsor ID
- N.CET-Liguria:265-2023-DB13200
- Conditions
- Survivorship, Late Effect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- currently in treatment for secondary malignancy or relapse of primary malignancy;
- have already received previous versions of the SurPass (v1.0 - 1.2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survivorship passport (SurPass) deliveryThe 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. | Other | – |
Primary outcome
Study of activation after the delivery of the personal SurPass v2.0
Time frame: Before (2-8 weeks) and after (2-3 months) SurPass delivery
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.
5 secondary outcomes
Study of empowerment after the delivery of the personal SurPass v2.0
Time frame: Before (2-8 weeks) and after (2-3 months) SurPass delivery
Study of CCS quality of life
Time frame: Before (2-8 weeks) and after (2-3 months) SurPass delivery
Study of satisfaction of HCPs and CCS with the digital SurPass tool
Time frame: At SurPass delivery and after (2-3 months)
Study of emotional impact after the delivery of the personal SurPass v2.0
Time frame: After (2-3 months) SurPass delivery
Study of economical impact after the delivery of the personal SurPass v2.0
Time frame: Imp-Cost questionnaire: baseline at SurPass delivery. Op-Cost: immediately after SurPass delivery. CCS Cost Qx: within 3 months after SurPass delivery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Background: PubMed 17543517Haupt 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.
- Background: PubMed 29946794Jankovic 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.
- Background: PubMed 30138773Haupt 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.
- Background: PubMed 34953441van 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.
- Background: PubMed 34333209van 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.
- Individual participant dataSharing planned: No
Related trials for Survivorship
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Active, not recruiting
Virtual Art Therapy Assisted Re-Integration to Improve Biopsychosocial Outcomes in Adolescent and Young Adult Cancer Survivors, AVATARS Trial
Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
RecruitingObservational study
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis
Recruiting
At-home Breast Oncology Care Delivered With E-health Solutions
Patient Engagement, Patient Activation
Recruiting
Improving Adherence to Chronic Disease Medication Regimens Among Patients With Recently Diagnosed Cancer
Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Bagnasco contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survivorship and Late Effect, run by Istituto Giannina Gaslini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Muraca, MD (01056363462, monicamuraca@gaslini.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of activation after the delivery of the personal SurPass v2.0 (time frame: Before (2-8 weeks) and after (2-3 months) SurPass delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05982587, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.