No registrations found.
ID
Source
Brief title
Health condition
Cancer
Kanker
Sponsors and support
Intervention
Outcome measures
Primary outcome
Return-to-work and quality of life.
Secondary outcome
1. Work ability;
2. Work limitations;
3. Feasibility;
4. Direct/indirect costs of the intervention.
Background summary
Rationale:
Survival rates of cancer have been increasing in recent years. It is generally assumed that the incidence of cancer in the working population in western countries will increase as well. For many cancer patients, cancer has become a chronic disease which causes poorer general health outcomes in comparison to the general population. The burden of the diseases itself and the treatment affects quality of life in all its aspects and one of these aspects is return-to-work. Earlier research showed that not all cancer patients who were working prior to their diagnosis, returned to work. Moreover, cancer patients have the highest prevalence of work impairments in comparison to patients with other chronic illnesses. To reduce these negative consequences for cancer patients as well as for the society at large an intervention has been developed to enhance return-to-work. The intervention will be carried out by a nurse who will provide counselling according to a special developed protocol. The hypothesis is that the patients who were counselled according to the intervention will return-to-work earlier and will have a better quality of life than patients who were counselled according to usual care.
Objective:
Primary objective: to determine the effect of the intervention on return-to-work and quality of life.
Secondary objectives:
To determine the effect of the intervention on the work ability and on the work limitations. To determine the feasibility of the intervention and the direct and indirect costs of the intervention.
Study design:
Randomised controlled trial with a follow-up of 24 months. Patients will be randomised to a control group a or to an intervention group. Patients in the control group will get care as usual and patients in the intervention group will get the intervention.
Study population:
Patients with a primary diagnosis of cancer, 18 - 60 years old.
Intervention:
A vocational rehabilitation intervention. Patients in the control group will be counselled according to usual care and patients in the intervention group will be counselled according to a special developed protocol (the intervention).
Main study parameters/endpoints:
Return-to-work and quality of life.
Study objective
The hypothesis is that the patients who were counselled according to the intervention will return-to-work earlier and will have a better quality of life than patients who were counselled according to usual care.
Study design
Baseline, 6,12,18 and 24 months after baseline.
Intervention
A vocational rehabilitation intervention. Patients in the control group will be counselled according to usual care and patients in the intervention group will be counselled according to a special developed protocol (the intervention). The duration of the intervention is at most 14 months.
Coronel Instituut voor Arbeid en Gezondheid, AMC,
Meibergdreef 9/K0-110
Amsterdam 1105 AZ
The Netherlands
+31 (0)20-566 3279
S.J.Tamminga@amc.uva.nl
Coronel Instituut voor Arbeid en Gezondheid, AMC,
Meibergdreef 9/K0-110
Amsterdam 1105 AZ
The Netherlands
+31 (0)20-566 3279
S.J.Tamminga@amc.uva.nl
Inclusion criteria
1. Primary diagnosis of cancer with a one year survival rate of approximately 80% and treatment with curative intent;
2. Age between 18 and 60 years;
3. Paid employment at the time of diagnosis;
4. Sick listed.
Exclusion criteria
1. Not able to understand, speak, read or write Dutch sufficiently;
2. Severe mental disorder or other severe co-morbidity;
3. Primary diagnosis of cancer has been made more than two months ago;
4. Patients who visit the hospital for a second opinion;
5. Primary diagnosis of testis cancer;
6. Primary diagnosis of non-melanoma or melanoma skin cancer.
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 | NL1579 |
| NTR-old | NTR1658 |
| Other | METC AMC : 08/267 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |