Our main objective is to assess QoL and disease-specific symptoms over time. Our secondary objectives are to identify demographic, environmental, biological, physiological and personality characteristics of TC patients who are at high risk for poor…
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
QoL and disease-specific symptoms over time.
Secondary outcome
fatigue, sleep, physical activity, anxiety, depression, health care
utilisation, and employment.
Background summary
Whilst some studies have found that individuals with thyroid cancer (TC)
generally have a quality of life (QoL) that it is comparable to those in the
general population most recent studies reported statistically significant and
clinically relevant lower levels of physical and psychosocial functioning, and
significantly more symptoms (e.g. fatigue, dyspnea, insomnia, appetite
problems) among TC patients compared to an age- and sex matched normative
population. However, most studies on QoL among TC patients are limited by the
cross-sectional study designs and lack of data about (mediating) mechanisms.
More research is needed into the mechanisms leading to worse QoL outcomes among
thyroid cancer patients.
Study objective
Our main objective is to assess QoL and disease-specific symptoms over time.
Our secondary objectives are to identify demographic, environmental,
biological, physiological and personality characteristics of TC patients who
are at high risk for poor physical and psychosocial outcomes (general and
disease-specific QoL, fatigue, sleep, physical activity, anxiety, depression,
health care utilisation, and employment).
Another objective is to analyse mediating mechanisms (e.g. inflammation levels,
genetic markers, expression levels, bacterial flora, body composition, and
heart rate) associated with poor outcomes in TC patients.
The main research questions that need to be answered are:
1) What is the level of QoL and disease-specific symptoms over time among TC
patients?
2) What is the role of demographic (age, gender), environmental factors (food
intake, body weight, body composition), clinical (tumour stage, treatment),
biological (DNA and serum markers), physiological (heart rate) and personality
(optimism, illness perception) characteristics on physical and psychosocial
outcomes (general and disease-specific quality of life, fatigue, sleep,
physical activity, anxiety, depression, health care utilisation, and
employment) of TC patients? In other words, who is at risk?
3) What is the association of mediating mechanisms (e.g. inflammation levels
including Dietary Inflammatory Index, genetic markers, expression levels,
bacterial flora (microbiome), body composition, and heart rate) with poor
outcomes in TC patients? In other words, why is a person at risk?
Study design
Longitudinal population-based study.
Study burden and risks
On an individual level, patients who participate are asked to complete
questionnaires so there is no risk in participation. The collection of blood
(which takes about 10 minutes) and stool samples (only at Radboud and UMCG) is
minimally invasive. Optionally, patients can choose whether they are interested
in filling out food diaries (3 days). Wearing the Fitbit for 14 consecutive
days and having a weighing scale at the house is considered to be minimally
invasive. Furthermore, patients can call a researcher (psychologist) or an
independent doctor for more information about this study.
warandelaan 2
Tilburg 5037AB
NL
warandelaan 2
Tilburg 5037AB
NL
Listed location countries
Age
Inclusion criteria
Thyroid cancer population
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Diagnosed with thyroid cancer
- 18 years or older
- Able to fill out questionnaires in Dutch
Norm population
In order to be eligible for participation in this study, a participant must
meet all of the following criteria:
- 18 years or older
- Able to fill out questionnaires in Dutch
- Live near one of the WaTCh-hospitals for blood draw
Exclusion criteria
TC patients:
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Patients with cognitive impairment will not be included because of expected
difficulties in completing these questionnaires without assistance.
- Patients who are not able to read or write Dutch will be excluded, as they
are not able to complete a Dutch questionnaire.
Norm population:
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Participants with cognitive impairment will not be included because of
expected difficulties in completing the questionnaire without assistance
(already not included in the LISS panel).
- Participants who are not able to read or write Dutch will be excluded, as
they are not able to complete a Dutch questionnaire (already not included in
the LISS panel).
- Participants with a (previous) diagnosis of a carcinoma, except for basal
cell carcinoma of the skin.
- Participants who have a household member already included in this study, to
ensure independence of answers.
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 | NL65161.028.18 |