Quality of LifeNCT05379387
Health-related Quality of Life and Late Effects Among SURVivors of Cancer in Adolescence and Young Adulthood: The SURVAYA Study
An observational study of Quality of Life and Late Effect, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
Rationale: Adolescent and young adult (AYA) cancer survivors, diagnosed between 18-39 years, much more than children, suffer from delay in diagnosis, lack of centralization of care, age-adjusted expertise and follow-up care. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Quality of Life, Late Effect, Survivorship
- How many people
- 4,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2019to 1 Jun 2021
- 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 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Study population: All AYA cancer patients, diagnosed at age 18-39 years and treated in one of the participating hospitals
Who may be able to join
- Pathological confirmed cancer diagnosis;
- Age 18 - 39 years at time of first cancer diagnosis;
- Provide written informed consent.
- Treated in an Academic hospital or Netherlands Cancer Institute
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: Adolescent and young adult (AYA) cancer survivors, diagnosed between 18-39 years, much more than children, suffer from delay in diagnosis, lack of centralization of care, age-adjusted expertise and follow-up care. The distribution of tumor types, biology, risk factors, developmental challenges and treatment regimens are different in AYAs compared to children. Therefore findings derived from childhood cancer survivors cannot be extrapolated to AYAs. Likewise, several large tumor-specific cohort studies exist that do not specifically address unique AYA age-specific issues. Globally, so far, the identification of AYA 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 (e.g. lifestyle) and host factors (e.g. genetic); or combinations of influences for impaired (age-specific) 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.
Objective: To examine the prevalence, risk factors and mechanisms of impaired health outcomes (health-related quality of life and late effects) among a population-based sample of AYA cancer survivors. Study design: Retrospective, population-based, observational cohort study.
Study population: AYA cancer survivors, diagnosed at age 18-39 years between 1999-2015, identified from the Netherlands Cancer Registry (NCR), and alive 5-20 year after diagnosis Main study parameters/endpoints: Health-related quality of life; late effects
- Conditions
- Quality of Life, Late Effect, Survivorship, Lifestyle, Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
The EORTC QLQ-C30 is a 30-item HRQoL questionnaire consisting of five functional scales (physical, role, cognitive, emotional and social), a global quality of life scales, symptom scales (fatigue, pain, nausea and vomiting) and a number of single items assessing common symptoms (dyspnea, loss of appetite, sleep disturbance, constipation and diarrhea) and perceived financial impact of the disease. After linear transformation, all scales and single item measures range in score from 0-100. A higher score on the functional scales and global QoL means better functioning and HRQoL, whereas a higher score on the symptom scales means more complaints.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 May 2019
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winette van der Graaf, Prof, Study director, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AvL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379387
- Sponsor's protocol ID
- IRBd18122
- Status last verified
- May 2022
- First submitted
- 13 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Janssen SHM, Vlooswijk C, Bijlsma RM, Kaal SEJ, Kerst JM, Tromp JM, Bos MEMM, van der Hulle T, Lalisang RI, Nuver J, Kouwenhoven MCM, van der Graaf WTA, Husson O. Health-related quality of life of long-term adolescent and young adult (AYA) cancer survivors compared to a matched normative population: results of the SURVAYA study. J Cancer Surviv. 2025 Jun 17. doi: 10.1007/s11764-025-01818-0. Online ahead of print.
PubMed 40528140Janssen SHM, Vlooswijk C, Bijlsma RM, Kaal SEJ, Kerst JM, Tromp JM, Bos MEMM, van der Hulle T, Lalisang RI, Nuver J, Kouwenhoven MCM, van der Graaf WTA, Husson O. Health-related conditions among long-term cancer survivors diagnosed in adolescence and young adulthood (AYA): results of the SURVAYA study. J Cancer Surviv. 2025 Dec;19(6):1821-1834. doi: 10.1007/s11764-024-01597-0. Epub 2024 May 13.
PubMed 38740702
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life and Late Effects Among SURVivors of Cancer in Adolescence and Young Adulthood: The SURVAYA Study
- ClinicalTrials.gov ID
- NCT05379387
- Acronym / sponsor ID
- IRBd18122
- Conditions
- Quality of Life, Late Effect, Survivorship, Lifestyle, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 18 May 2022 (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.
Rationale: Adolescent and young adult (AYA) cancer survivors, diagnosed between 18-39 years, much more than children, suffer from delay in diagnosis, lack of centralization of care, age-adjusted expertise and follow-up care. The distribution of tumor types, biology, risk factors, developmental challenges and treatment regimens are different in AYAs compared to children. Therefore findings derived from childhood cancer survivors cannot be extrapolated to AYAs. Likewise, several large tumor-specific cohort studies exist that do not specifically address unique AYA age-specific issues. Globally, so far, the identification of AYA 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 (e.g. lifestyle) and host factors (e.g. genetic); or combinations of influences for impaired (age-specific) 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.
Objective: To examine the prevalence, risk factors and mechanisms of impaired health outcomes (health-related quality of life and late effects) among a population-based sample of AYA cancer survivors. Study design: Retrospective, population-based, observational cohort study.
Study population: AYA cancer survivors, diagnosed at age 18-39 years between 1999-2015, identified from the Netherlands Cancer Registry (NCR), and alive 5-20 year after diagnosis Main study parameters/endpoints: Health-related quality of life; late effects
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All AYA cancer patients, diagnosed at age 18-39 years and treated in one of the participating hospitals
Key inclusion criteria (4 listed)
- Pathological confirmed cancer diagnosis;
- Age 18 - 39 years at time of first cancer diagnosis;
- Provide written informed consent.
- Treated in an Academic hospital or Netherlands Cancer Institute
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health related quality of life
Time frame: Day 1
The EORTC QLQ-C30 is a 30-item HRQoL questionnaire consisting of five functional scales (physical, role, cognitive, emotional and social), a global quality of life scales, symptom scales (fatigue, pain, nausea and vomiting) and a number of single items assessing common symptoms (dyspnea, loss of appetite, sleep disturbance, constipation and diarrhea) and perceived financial impact of the disease. After linear transformation, all scales and single item measures range in score from 0-100. A higher score on the functional scales and global QoL means better functioning and HRQoL, whereas a higher score on the symptom scales means more complaints.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Derived from this study: PubMed 40528140Janssen SHM, Vlooswijk C, Bijlsma RM, Kaal SEJ, Kerst JM, Tromp JM, Bos MEMM, van der Hulle T, Lalisang RI, Nuver J, Kouwenhoven MCM, van der Graaf WTA, Husson O. Health-related quality of life of long-term adolescent and young adult (AYA) cancer survivors compared to a matched normative population: results of the SURVAYA study. J Cancer Surviv. 2025 Jun 17. doi: 10.1007/s11764-025-01818-0. Online ahead of print.
- Derived from this study: PubMed 38740702Janssen SHM, Vlooswijk C, Bijlsma RM, Kaal SEJ, Kerst JM, Tromp JM, Bos MEMM, van der Hulle T, Lalisang RI, Nuver J, Kouwenhoven MCM, van der Graaf WTA, Husson O. Health-related conditions among long-term cancer survivors diagnosed in adolescence and young adulthood (AYA): results of the SURVAYA study. J Cancer Surviv. 2025 Dec;19(6):1821-1834. doi: 10.1007/s11764-024-01597-0. Epub 2024 May 13.
- Individual participant dataSharing planned: Yes
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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.
Winette van der Graaf, Prof study director
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AvL)
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 Quality of Life and Late Effect, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 2 Jun 2022. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: Day 1). 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 NCT05379387, which also lists 2 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 2 Jun 2022.