Health-related Quality of Life and Late Effects Among SURVivors of Cancer in Adolescence and Young Adulthood: The SURVAYA Study

Cancer Clinical Trial

Official title:

Health-related Quality of Life and Late Effects Among SURVivors of Cancer in Adolescence and Young Adulthood: The SURVAYA Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05379387
• Other study ID #: IRBd18122
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2022
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cancer
• Late Effect
• Lifestyle
• Quality of Life
• Survivorship

Locations

Country	Name	City	State
Netherlands	Antoni van Leeuwenhoekziekenhuis	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1