1. What is the level of psychological distress among cervical cancer patients over time?2. What is the role of characteristics of the individual, characteristics of the environment, biological function, overall quality of life, functional status and…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Cervix disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
psychological distress
Secondary outcome
Characteristics of the individual, characteristics of the environment,
biological function, overall quality of life, symptoms, functional status, and
general health perceptions.
Background summary
A growing number of cervical cancer patients live years beyond their cancer
diagnosis and ultimately survive their disease. Cervical cancer patients report
higher levels of psychological distress compared to other (gynecological)
cancer types, resulting in physical and psychosocial limitations. The
mechanisms explaining why some patients do, and others do not experience
persistent psychological distress after cervical cancer remain unclear.
Study objective
1. What is the level of psychological distress among cervical cancer patients
over time?
2. What is the role of characteristics of the individual, characteristics of
the environment, biological function, overall quality of life, functional
status and general health perceptions, in explaining psychological distress
among cervical cancer patients?
3. What is the impact of cervical cancer on distress of partners of patients?
Study design
This observational study is a population-based study in which we include
cervical cancer patients and their partners shortly after diagnosis and follow
them until 10 years after diagnosis. The patients and their partners are asked
to complete questionnaires directly after diagnosis, after 6 months, and after
1, 2, 5 and 10 years. Moreover, patients are asked to wear a Fitbit at 6, 12
and 24 months after diagnosis. Patients who complete the questionnaire online,
are additionally asked to complete an online nutrition diary *De Eetmeter*.In a
subsample additional measurements will be executed. These measurments will
include; drawing blood and analysing a hair sample.
Study burden and risks
The burden of this study is de completion of the questionnaires, which takes
about 30 to 60 minutes and wearing a Fitbit. For the subsample, the additional
burden is to draw blood and to take a hair sample.
Warandelaan 2
Tilburg 5037AB
NL
Warandelaan 2
Tilburg 5037AB
NL
Listed location countries
Age
Inclusion criteria
- Newly diagnosed with stage I-III cervical cancer
- Being at least 18 years of age.
Exclusion criteria
- Cognitive impairment
- Not able to read or write Dutch.
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 | NL67509.028.18 |