Primary study objective The primary objective of this study is to determine the (cost-) effectiveness of tailored support for work- related problems of gastro intestinal (GI) cancer patients on return to work compared to GI cancer patients who…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms benign
- Economic and housing issues
Synonym
Health condition
werk- gerelateerde aangelegenheden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Return to work
Secondary outcome
Work ability
Work limitations
Quality of life
Costs (direct and indirect costs of the intervention)
Background summary
Survival rates of cancer have been increasing in the last years due to
screening programs, early detection and continuously improving treatments which
contributes to less invasive treatments. Early detection and advances in new
and less invasive treatments have improved the prognosis for many cancer
patients in the recent years. A diagnosis of cancer has therefore for many
people changed from a life threatening disease into a chronic condition. Almost
half of the people diagnosed with cancer are of working age. The increasing
retirement age will additionally increase the number of cancer survivors in the
working population. Surely it is important that cancer patients are able to
RTW, because of a fulfilling work life is associated with the quality of life
and provides a much- needed income. This is underlined by the oncological
rehabilitation guideline, which aims at helping cancer patients to enhance
quality of life, daily functioning and labour participation. Most cancer
survivors want to resume work after treatment, but regrettably, not all
survivors are able to do so.
It is essential to provide a tailored in- hospital based care program to
support the RTW process, because many experience difficulties in this process
both at the beginning and at the end of the treatment process. So far no in-
hospital intervention is equipped for GI cancer patients who are confronted
with specific problems such as eating or defecation problems which might
interfere with work. Work- related problems could vary in severity, it is of
interest to offer tailored support, however there is no screenings instrument
yet for detecting the severity of work- related problems.
Therefore we propose to adapt and customize a hospital- based intervention to
enhance the RTW of GI cancer patients. The intervention aims at reaching this
aim by offering a tailored support in which the severity of work- related
problems vary. Based on the patients *answers from a baseline questionnaire and
a decision framework, the patient will be referred into one of supports within
the intervention with different disciplines who will offer the tailored
support. The intervention is innovative based on the current oncological
rehabilitation guideline and it blends oncological and occupational care in the
clinical setting, which is an essential part of high- quality oncological care.
Study objective
Primary study objective
The primary objective of this study is to determine the (cost-) effectiveness
of tailored support for work- related problems of gastro intestinal (GI) cancer
patients on return to work compared to GI cancer patients who receive care as
usual.
Secondary study objective
The secondary objective of this study is to determine the work disability, work
limitations and the quality of life of GI cancer patients who receive the
tailored support for work- related problems compared to GI cancer patients who
receive care as usual.
Study design
The study will be carried out as a multicentre Randomised Controlled Trial
(RCT) with a follow up of 12 months. Patients will be randomised to a control
group and will receive care as usual or to an intervention group and will
receive the intervention (tailored support with work- related problems).
Intervention
A vocational rehabilitation program whereby a tailored support is offered
within the in- hospital setting. Because work- related problems could differ in
severity, the intervention is split into three supports namely, support A,
support B and support C. Within these different support the health care
discipline who provide the supportive care is different. In support A that will
be an oncological nurse, in support B an occupational physician (specialized in
RTW of oncological patients) and in support C there will be a multidisciplinary
team (including at least an oncological nurse, the treating physician and an
occupational physician) that discuss the work- related problems. Before this
multidisciplinary meeting the occupational physician first will have a meeting
with the patient .The occupational physician will be in lead in the
multidisciplinary team consultation and is the designated person that will
take care of the feedback towards the patient in another face- to- face
meeting.
Study burden and risks
The burden for the patients in the control group will be 2.5 hours for filling
out 5 questionnaires over a period of 12 months. The burden for the patients in
the intervention groups will be 0.5 hours per meeting for the intervention plus
2.5 hours for filling out 5 questionnaires. The are no risks associated with
participation.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with a primary diagnosis of gastrointestinal (GI) cancer
Treatment with a curative intent
Age between 18 and 63 years old
In paid employment or self-employed at time of diagnosis
Patients on sick leave as a result of cancer related- work problems
Patients with sufficient knowledge of the Dutch language
Written informed consent
Exclusion criteria
Severe mental disorder or other severe co- morbidity
Patients who will receive primary cancer treatment at another hospital than hospital of recruitment
Patients who visit the hospital for a second opinion
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 | NL51444.018.14 |
Other | NTR #5022 |