1. To assess the test characteristics (specificity, sensitivity, positive predictive value and negative predictive value) and cut-off value for severe fatigue of the VVV as screenings test for fatigue compared to the CIS 20 R . 2. To evaluate the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vermoeidheid na kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The individual diagnostic value of the VVV in detecting cancer related fatigue
Prevalence of concentration problems (CIS 20 R >= 19) in survivor group and
control group The influence of cancer and cancer treatment on fatigue in
childhood cancer survivors. The influence of depression and reduced quality of
life on fatigue in childhood cancer survivors. The influence of organ
dysfunction on fatigue in childhood cancer survivors.
Secondary outcome
n/a
Background summary
Advances in diagnosis and treatment of childhood cancer over the last decades
have dramatically increased long-term survival. As a result, the numbers of
childhood cancer survivors (CCS) are growing and it has become increasingly
clear that the former disease and its treatment can significantly impair
long-term health. The need for long-term follow-up is uniformly recognized.
Research focusing on identification and characterization of high-risk
populations is an essential foundation on which to build evidence-based
recommendations for long-term follow-up. Furthermore, research focusing on more
accurate screening tests and effective interventions is needed to reduce excess
morbidity and mortality in CCS. The SKION LATER Q2008 - fatigue study phocuses
on fatigue problems in CCS.
Study objective
1. To assess the test characteristics (specificity, sensitivity, positive
predictive value and negative predictive value) and cut-off value for severe
fatigue of the VVV as screenings test for fatigue compared to the CIS 20 R . 2.
To evaluate the prevalence of cancer(treatment) induced concentration problems
in the survivors group compared to healthy controls. 3. To estimate the
prevalence of fatigue in childhood cancer survivors in relation to diagnosis,
treatment and age of treatment. 4. To estimate the prevalence of fatigue in
childhood cancer survivors in relation to mental health and quality of life
scores. 5. To estimate the prevalence of fatigue in childhood cancer survivors
in relation to neurocognitive outcomes. 6. To estimate the prevalence of
fatigue in childhood cancer survivors in relation to organ dysfunction and body
composition.
Study design
All survivors of childhood cancer will be invited for a visit at the LATER out
patient clinic. For this study SKION LATER Q2008 - Fatigue, questionnaires will
be filled in by the survivors of childhood cancer and their siblings who are 12
years or older ( VVV and CIS 20 test).
Study burden and risks
The survivors will be invited for the Q2008 SKION LATER-fatigue study close to
a visit to the LATER out patient clinic. The completion of questionnaires will
not take more than 15 minutes.
Heidelberglaan 25
Utrecht 3584CS
NL
Heidelberglaan 25
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
All patients who were treated for childhood cancer (before age 18) in one of
the Pediatric Oncology Centers between 1960 and 2001 and who survived for at
least 5 years after diagnosis will be included in the SKION LATER study.
Participating centres are located in Amsterdam (VU University Medical Center
(VUMC)), Groningen (Children's Cancer Center/ University Medical Center
Groningen (UMCG)), Rotterdam (Rotterdam Erasmus MC-Sophia (REMC-S), Nijmegen
(University Medical Center Nijmegen (UMCN)), Leiden (Leiden University Medical
Center (LUMC) and Utrecht (Princess Máxima Center for Pediatric Oncology
(PMC)).
Exclusion criteria
diagnosis of childhood cancer with survival less than 5 years, age at diagnosis
>17 years or diagnosis while residing in foreign country
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34983.018.10 |