The primary aim of the study is to develop the Dutch version of the FCRI (Fear of Cancer Related Inventory)
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Dutch version of the FCRI, that is reliable and a valid questionnaire for
assessing fear of cancer recurrence
Secondary outcome
N.A.
Background summary
Fear of disease recurrence (FOR) is a common concern among cancer patients. The
fear of cancer recurrence (FCR) is the most long-term psychological
consequences of surviving cancer and it is persist long after the termination
of treatment. In this study, we used the FCR definition made by Vickberg et al.
: the fear or worry that the cancer will return or progress in the same organ
or in another part of the body. There is not a standard fear of recurrence
(FOR) used in the majority of studies. Several studies used a single question
or a few items to examine FOR. Simard and Sarvard provided a short overview of
existing FOR questionnaires. Some questionnaires have been specifically
developed for breast cancer patients, such as the Concerns About Recurrence
Scale (CARS). The CARS is the only questionnaire that has been translated and
validated in Dutch for investigate FOR. Only the problem is that the CARS not
incorporated all relevant dimensions of FCI. This was the main reason for
developing the Fear of Cancer Related Inventory (FCRI). The FCRI that assesses
seven factors (triggers, severity, psychological distress, coping strategies,
functioning impairments, insight and reassurance) is the only measuring that
incorpates ways patients cope with FOR. It is important to assess this aspect
because the way patients cope with FOR will determine the amount of
psychological distress that patients will experience. A disadvantage of the
FCRI is that it is developed and validated in Canada among a heterogeneous
cancer population, of which one third had breast cancer.
Study objective
The primary aim of the study is to develop the Dutch version of the FCRI (Fear
of Cancer Related Inventory)
Study design
The first part consists of developing the Dutch version of the FCRI using the
standard translation method of the WHOQOL instruments, which is based on the
WHO guidelines, and running focus groups. Participant for the focus groups
(N=30) will be recruited by health professionals working in the hospital. Once
the health professional has obtained the patient*s permission to be approached
by the student, this student will phone the patients. Further information about
this part of the study will be given by phone, and when they still interested,
they receive a written document with comprehensive information about the study,
explaining the aims and procedures of the focus group meetings. Based on the
result of the focus groups, the Dutch FCRI is adapted.
For the validation of the Dutch version of the FCRI, the other patients will
subsequently receive a letter explaining the purpose of the study and asking
them to participate. Patients also receive an informed consent form. When the
patient give permission they receive a set of questionnaires and the signed
informed consent form. One hundred long-term survivors (end of treatment at
least 2 years ago) will be asked to complete the FRCI twice with an interval of
1 months to examine test-retest reliability.
The set of questionnaires for the validation part of this study consist of
seven questionnaires examining:
• FOR (Dutch version of the FCRI and CARS-DLV)
• Depressive symptoms and anxiety (CES-D and STAI state scale)
• Coping strategies (CISS), QOL (WHOQOL-Bref)
• Trait anxiety (STAI trait scale)
A sample size of 75 patients is sufficient to test the construct validity
(Pearson correlations will be calculated between the Dutch FCRI and the other
questionnaires).
A sample size of 400 patients is sufficient to test the structure of the FCRI
(confirmatory factor analysis (AMOS 4.0)).
Study burden and risks
N.A.
Hilvarenbeekseweg 60
5022 GC Tilburg
NL
Hilvarenbeekseweg 60
5022 GC Tilburg
NL
Listed location countries
Age
Inclusion criteria
Women who where treated for breast cancer in the St. Elisabeth hospital (Tilburg) between January 2000 and September 2010 and who are still alive.
Exclusion criteria
disease recurrence or metastases at baseline; history of neuropsychologic and/ or psychiatric signs or symptoms that lead to deviant neuropsychologic test results (e.g. dementia); the use of medication that may lead to deviant neuropsychological results; alcohol and drug addiction; poor expression in the dutch language
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 | NL37119.008.11 |