Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04682470
Status:
RECRUITING
Last Update Posted:
2022-03-02
First Post:
2020-11-16
Brief Title:
The Prospective Observational COMPRAYA Cohort Study
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
COMPRehensive Assessment of Prevalence Risk Factors and Mechanisms of Impaired Medical and Psychosocial Health Outcomes Among Adolescents and Young Adults With Cancer the Prospective Observational COMPRAYA Cohort Study
Status:
RECRUITING
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPRAYA
Brief Summary:
Rationale Childhood cancer survivorship attracts attention globally because successes in treatment have led to increasing number of survivors who reach adulthood in which survivorship issues affecting health-related quality of life HRQoL become prominent Most paediatric patients are treated intensively with irradiation andor chemotherapy which put them at risk for early andor late adverse medical and psychosocial events In contrast much less is known about adolescent and young adult AYA cancer patients diagnosed between 18-39 years who with an 80 chance to survive also have a long life ahead AYA cancer patients much more than children suffer from delay in diagnosis lack of centralization of care ageadjusted expertise and AYA follow-up care AYAs typically present with a rare tumour either with a paediatric malignancy eg acute lymphoblastic leukaemia paediatric brain tumours a more typical tumour of AYA age eg Hodgkins disease germ cell cancer melanoma thyroid cancer or with an adult tumour at unusual young age eg gastrointestinal lung breast carcinomas Next to these differences in epidemiology the tumour biology developmental challenges eg forming relationships becoming financially independent having children and treatment regimens differ between AYAs and children and therefore findings derived from childhood cancer survivors cannot be extrapolated to AYAs Furthermore novel treatments with targeted agents or immunotherapy are more likely to be administrated to AYAs compared to children Finally a rare group of incurable AYA cancer patients will survive for many years for whom health outcome and supportive care intervention data are lacking
Globally so far the identification of AYA cancer patient subgroups that might be more susceptible to poor health outcomes has not been systematically addressed The role of sociodemographic and treatment-associated risks external exposures eg lifestyle and host factors eg genetic biological physiological or combinations of influences for impaired agespecific health outcomes remains largely unknown Understanding who is at risk and why will support the development of evidence-based AYA prevention treatment and supportive care programs and guidelines in co-creation with AYA cancer patients
Objective To examine the prevalence risk factors and mechanisms of impaired health outcomes short- and long-term medical and psychosocial effects and late effects over time among a population-based sample of AYA cancer patients
Study design Prospective observational cohort study Study population All AYAs diagnosed 18-39 years at primary diagnosis with cancer any type within the first 3 months after diagnosis eligibility window of 1 month to ensure all eligible AYA cancer patients can be included in one of the participating centres or treated in one of these centres in The Netherlands
Main study parametersendpoints The main outcomes are medical eg second tumour survival fertility and psychosocial eg distress health outcomes Other study parameters covariatesmoderatorsmediators are characteristics of the individual eg age sex cultural background partner status educational level occupation tumour type disease stage body composition comorbid conditions coping style characteristics of the environment eg cancer treatment lifestyle and genetic and biological factors eg family history of cancer stress and inflammation markers eg cortisol IL-6 microbiome
Nature and extent of the burden and risks associated with participation benefit and group relatedness On an individual level patients who participate are asked to complete questionnaires on an annual basis for at least 10 years All sample collections will take place at three time points 0-3 months after diagnosis baseline 2 and 5 years except blood for DNA analyses which will only take place at baseline The collection of blood hair and faeces at three occasions is minimally invasive and the risks of blood draws hair and fecal sampling are negligible All safety measures and procedures will be performed according to local guidelines Patients will not experience direct benefit from participation in the COMPRAYA study
By participating patients will contribute to a better insight in the prevalence of impaired medical and psychosocial age-specific health outcomes in AYA and evidence on factors associated with these health outcomes This will lead to better and more personalized cancer care and supportive care tools for future AYA cancer patients
Globally so far the identification of AYA cancer patient subgroups that might be more susceptible to poor health outcomes has not been systematically addressed The role of sociodemographic and treatment-associated risks external exposures eg lifestyle and host factors eg genetic biological physiological or combinations of influences for impaired agespecific health outcomes remains largely unknown Understanding who is at risk and why will support the development of evidence-based AYA prevention treatment and supportive care programs and guidelines in co-creation with AYA cancer patients
Objective To examine the prevalence risk factors and mechanisms of impaired health outcomes short- and long-term medical and psychosocial effects and late effects over time among a population-based sample of AYA cancer patients
Study design Prospective observational cohort study Study population All AYAs diagnosed 18-39 years at primary diagnosis with cancer any type within the first 3 months after diagnosis eligibility window of 1 month to ensure all eligible AYA cancer patients can be included in one of the participating centres or treated in one of these centres in The Netherlands
Main study parametersendpoints The main outcomes are medical eg second tumour survival fertility and psychosocial eg distress health outcomes Other study parameters covariatesmoderatorsmediators are characteristics of the individual eg age sex cultural background partner status educational level occupation tumour type disease stage body composition comorbid conditions coping style characteristics of the environment eg cancer treatment lifestyle and genetic and biological factors eg family history of cancer stress and inflammation markers eg cortisol IL-6 microbiome
Nature and extent of the burden and risks associated with participation benefit and group relatedness On an individual level patients who participate are asked to complete questionnaires on an annual basis for at least 10 years All sample collections will take place at three time points 0-3 months after diagnosis baseline 2 and 5 years except blood for DNA analyses which will only take place at baseline The collection of blood hair and faeces at three occasions is minimally invasive and the risks of blood draws hair and fecal sampling are negligible All safety measures and procedures will be performed according to local guidelines Patients will not experience direct benefit from participation in the COMPRAYA study
By participating patients will contribute to a better insight in the prevalence of impaired medical and psychosocial age-specific health outcomes in AYA and evidence on factors associated with these health outcomes This will lead to better and more personalized cancer care and supportive care tools for future AYA cancer patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None