The primary objectives are:- to identify predictive factors for fatigue in cancer survivors on long-term sick leave. - to develop a prognostic instrument by which insurance physicians can assess future functional abilities, related to the work…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of the study is the level of fatigue, measured by
the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale. This
13-item scale is measured on a 5-point scale (range 0-52) , with 0 being the
worst possible score and 52 the best.
Secondary outcome
- perceived work ability, which will be assessed using the first three
questions of the Work Ability Index (WAI).
- disability percentage, which is expressed by the percentage of income-loss of
the previous job held.
- depression, which will be measured by the Center for Epidemiological Studies
- Depression scale (CES-D). The CES-D is a 20-items questionnaire, measured on
a four-point scale.
- quality of life, which will be assessed with the European Organisation for
Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ
C-30). This 30-item list incorporates nine multi-item scales: five functional
scales; three symptom scales and a global health and quality-of-life scale.
- coping, which will be measured with the Utrecht Coping List (UCL). The UCL
has 47 statements covering seven coping strategies and is scored on a
four-point scale.
- work load, work stress and need for recovery. Physical workload will be
measured with a seven-item scale, and work stress and need for recovery will
both be measured with a 11-item scale from the Dutch questionnaire on
Experience and Judgement of Work (VBBA).
- supervisor and co-worker social support will be measured with two subscales
(four items each) of a validated Dutch version of the Job Content Questionnaire
(JCQ).
- physical limitations, which will be measured with the mobility and ambulation
subscales of the Sickness Impact Profile (SIP). The SIP uses a series of
questions with two domains, i.e., physical and psychosocial.
Other study parameters
Both at baseline and one year follow-up, sociodemographics, disease-related
data, working hours, and disability percentage, as assessed by UWV, will be
gathered. Additional UWV file data, such as reintegration efforts, objection
and appeal procedures, and Functional Ability Lists will also be gathered.
Background summary
Fatigue is a common side effect of cancer and its treatment, as reported by
patients all over the world. Prevalence data in previous studies on fatigue
show a wide range, i.e., 4-100% percent, due to differences in study design,
timeframe, cancer site and stage, and treatment modalities. Apart from
hindering patients in daily house-hold activities, leisure-time or social
interactions, fatigue can have a significant impact on work ability. Moreover,
fatigue is associated with loss of productivity, reduction of working hours and
sick leave. Cancer survivors often experience return to work as getting back to
normal life and regaining a sense of control. However, fatigue may influence
return to work for several years, even after treatment has been completed. It
may even lead to permanent work disability. Therefore, the relationship between
cancer related fatigue and work ability deserves our attention. Especially in
cancer survivors on long-term sick leave, who report ongoing fatigue. That is,
the assessment of disability benefit claims is done by insurance physicians of
UWV, after two years of sick leave. For them, cancer related fatigue and the
extent it will affect work ability are difficult to assess. Numerous
prospective studies have investigated the relationship between fatigue and work
ability. Though, most studies focus on the association between fatigue and
return to work within two years of sick leave. Therefore, it is necessary to
study prognostic factors for fatigue in cancer survivors on long-term sick
leave, and to assess the association of fatigue with work ability in these
clients. Since fatigue is expected to affect return to work, gaining insight in
the course of fatigue may support the insurance physician in the assessment of
work ability of cancer survivors on long-term sick leave. In this study, we
aim, both quantitatively and qualitatively, to identify predictive factors for
fatigue in cancer survivors, who are on long-term sick leave, and its relation
with return to work. In addition, we aim to develop a prognostic instrument, by
which insurance physicians can assess future functional abilities of these
clients.
Study objective
The primary objectives are:
- to identify predictive factors for fatigue in cancer survivors on long-term
sick leave.
- to develop a prognostic instrument by which insurance physicians can assess
future functional abilities, related to the work perspective, of these
cancer survivors.
Secondary objectives are:
- to determine the association between fatigue and return to work in cancer
survivors on long-term sick leave.
- to identify predictive factors for a transition in the level of fatigue in
cancer survivors on long-term sick leave.
- to identify predictive factors for with fatigue related functional abilities,
e.g., physical limitations, in cancer survivors on long-term sick leave.
Study design
There are two elements in this study to answer the objectives:
1. A prospective cohort study: predictors for fatigue in cancer survivors on
long-term sick leave will be identified, using questionnaires (at baseline and
one year follow-up) and data of the insurance physicians and UWV. Also, the
association between fatigue and return to work will be explored. The
recruitment of participants will start mid 2011 and will last until mid 2012.
2. A qualitative study will be conducted using focus groups, each of which two
insurance physicians, two occupational physicians and two oncologists will
participate. Prognostic factors for cancer related fatigue and mediating
factors for return to work of cancer survivors will be discussed with these
health professionals. They will be asked about their knowledge and experiences,
and opinions regarding the importance of these factors will be gathered. Three
groups will be formed, with recruitment starting in September 2011. The process
of recruitment, formation and preparation of the focus groups, data gathering
and data processing will take till September 2012.
Study burden and risks
In this study no interventions will be applied.
van der Boechorststraat 7
1081 BT Amsterdam
NL
van der Boechorststraat 7
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
The study population of the prospective cohort study (n=400) will exist of cancer survivors who apply for a WIA benefit at the head office of UWV in Amsterdam, i.e., they approach a 104 weeks period of sick leave and make a first application for WIA benefit.
Exclusion criteria
1. Clients treated for cancer, who are too ill to visit the UWV office for the WIA assessment.
2. Clients treated for cancer, who do an appeal on WIA benefit due to another somatic or psychiatric disorder.
3. Clients treated for cancer, with prior WAO/WIA benefit.
4. Clients treated for cancer, who are voluntarily insured non-employees.
5. Clients receiving chemo- or radiotherapy
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 | NL35835.029.11 |