|- candidate number||5262|
|- NTR Number||NTR1658|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-feb-2009|
|- Secondary IDs||08/267 METC AMC|
|- Public Title||To enhance return-to-work in cancer patients.|
|- Scientific Title||To enhance return-to-work in cancer patients - a randomised controlled trial.|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Cancer|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2009|
|- planned closingdate||1-dec-2010|
|- Target number of participants||300|
|- Interventions||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.|
|- Primary outcome||Return-to-work and quality of life. |
|- Secondary outcome||1. Work ability;|
2. Work limitations;
4. Direct/indirect costs of the intervention.
|- Timepoints||Baseline, 6,12,18 and 24 months after baseline.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. S.J. Tamminga|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A.G.E.M. Boer, de|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Coronel Institute for Work and Health|
(Source(s) of Monetary or Material Support)
|Stichting Instituut GAK (SIG)|
|- Brief 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.
Primary objective: to determine the effect of the intervention on return-to-work and quality of life.
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.
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.
Patients with a primary diagnosis of cancer, 18 - 60 years old.
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.
|- Main changes (audit trail)|
|- RECORD||4-feb-2009 - 12-mrt-2010|