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ID
Source
Brief title
Health condition
Primary health condition: patients diagnosed with a primary gastro intestinal cancer who experience work- related problems.
- gastro intestinal cancer
- work related problems
- occupational support
- tailored support
- return to work
Sponsors and support
(in Dutch: KWF kankerbestrijding)
Dutch Cancer Society
(in Dutch: KWF kankerbestrijding)
Intervention
Outcome measures
Primary outcome
The primary outcome parameter in this study is return- to- work (RTW).
RTW is defined as time to partial or full RTW, meaning the number of calendar days between first day sick leave and first day at work. The patient must have returned to work (part time or full time) for at least 4 weeks successively.
Secondary outcome
-Work ability
Work ability will be assessed with the first three questions of the Work Ability Index (WAI), using a 10-point scale. These questions concerns the evaluation of current work ability compared to their life time best and current physical and mental work ability with respect to their job demands.
-Work limitations
Work limitations will be measured with the Work Limitation Questionnaire (WLQ), using a 5-point scale. This questionnaire evaluates the work disability and productivity (loss) in people with health problems. This questionnaire consists four subscales (25 items); work scheduling, physical demands, mental demands/ social demands and output demands.
-Quality of life
Quality of life (QoL) will be assessed with the SF-12 (12 items) and the EORTC QLQ-C30 (30 items). We are using two questionnaires to measure QoL; with the SF- 12 we could compare the participants in this study with the normal population and with the QLQ-C30 we could compare the QoL of patients with GI cancer against patients with other cancer diagnosis. These questionnaires provide insight in participants’ health, feelings and the ability to carry out usual activities.
-Costs
Direct and indirect costs including:
Costs to carry out the intervention (payment of the disciplines for the intervention meetings /nurse training) [euro’s]
Days of hospital admission [days]
Income [euro’s]
Work adjustments [e.g. no adjustments/reduction working hours/ other tasks plus open question]
Background summary
This study concerns about the psychological health of cancer patients, for which sustaining at or returning to work is important. Earlier research shows that early support is needed, but that no interventions exist for supporting patients with GI cancer and work- related problems early in the process of diagnosis and treatment. Therefore we have developed an in- hospital program to support the RTW process for GI cancer patients. The program offers tailored support varying the severity of work- related problems of GI cancer patients. The (cost)-effectiveness of the intervention will be determined in a multicentre Randomised Controlled Trial. It will contribute as a foundation for optimising future tailored work- related interventions in cancer care. The intention is to implement the intervention if it has been shown effective.
Study objective
In the intervention group patients with GI cancer and work-related problems will receive tailored support which will lead to a more successful return to work compared to the control group of patients with GI cancer and work -related problems receiving usual care.
Study design
The supportive care consists three counselling meetings.
The first meeting:
Is scheduled before the start of the treatment.
The second meeting:
Will be scheduled in consultation between patient and the supporting discipline after the first meeting (depending on diagnosis / treatment and preferences of the patient) and with a maximum of 3 – 6 months after the first meeting.
The third meeting
If there is an indication, will be scheduled on request / indication of patient and / or the supporting discipline of the second meeting (depending on diagnosis / treatment and preferences of the patient) and with a maximum of 6- 9 months after the first meeting.
Patients will fill in 5 questionnaires
Baseline
3 months
6 months
9 months
12 months
Intervention
Intervention: tailored support for work- related problems
Because work- related problems could differ in severity, the intervention is split into three types of supports namely, support A, support B and support C. Within these different supports the health care discipline that 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 oncological occupational physician) that discuss the work- related problems.
Patients are referred to a tailored support in the intervention on the basis of factors that are scored in patient questionnaires within the following categories; clinical history, work, work limitations and health status.
AnneClaire Zaman
P.O. Box 22660
Amsterdam 1100 DD
The Netherlands
+3120-566 4878 / +31642718309
a.c.zaman@amc.uva.nl
AnneClaire Zaman
P.O. Box 22660
Amsterdam 1100 DD
The Netherlands
+3120-566 4878 / +31642718309
a.c.zaman@amc.uva.nl
Inclusion criteria
Patients with a primary diagnosis of GI cancer
- Esophagus
- Stomach
- Liver
- Pancreas
- Biliary
- Small Intestine
- Colon
- Rectum
Age between 18 and 63 years old
In paid employment or self-employed at time of diagnosis
Patients on sick leave (partly or entirely) as a result of related- work problems due to cancer
Treatment with a curative intent
Patients with sufficient knowledge of the Dutch language (able to understand, speak, read or write)
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 |
|---|---|
| NTR-new | NL4920 |
| NTR-old | NTR5022 |
| Other | NL51444.018.14 : UVA2012-5619 |