|- candidate number||29747|
|- NTR Number||NTR7627|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-okt-2018|
|- Secondary IDs||UVA 2014‐7153 Dutch Cancer Society // W18_355 METC AMC|
|- Public Title||The missing link: optimizing return-to-work for employees with cancer, by supporting employers|
|- Scientific Title||A pilot-RCT to study the effectiveness of an intervention targeting employers, for successful return to work of employees diagnosed with cancer|
|- hypothesis||We expect that the intervention group, in which employees diagnosed with cancer inform their employer about an online toolbox, return to work more often, provided with a higher degree of successfulness, compared with the control group, in which employees do not inform their employer about the online toolbox. As such, we expect the intervention, an online toolbox targeting employers, to be effective for successful return to work (RTW) of employees diagnosed with cancer. |
|- Healt Condition(s) or Problem(s) studied||Cancer, Return to work, Employers, Workers|
|- Inclusion criteria||- Diagnosed with cancer <2 years ago. |
- Able to fill out three questionnaires in the next six months.
- Currently (partial) sick-listed for <1 year.
- Of the working age (18-63 years).
In paid employment under a temporary (>6 months remaining) or permanent contract on part-time, full-time of flexible basis.
- Able to understand, speak and read Dutch sufficiently.
|- Exclusion criteria||- Not yet disclosed being diagnosed with cancer to the employer.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2019|
|- planned closingdate||1-jan-2020|
|- Target number of participants|
|- Interventions||The intervention consists of an online toolbox targeting the participant’s employer. With ‘employer’ we refer to the person who is, from his/her role as (direct) supervisor, human resource manager or case-manager, in direct contact with the participant and from there responsible for guiding the participant at work. The online toolbox is an open-assess website containing to-the-point information, videos and checklists to support employers during the RTW process of an employee diagnosed with cancer.
Intervention group: Participants randomised in the intervention group will be asked to inform their employer about the online toolbox, either by email or letter. Employers will be asked to use the online toolbox throughout the RTW process of the participant.
Control group: Participants randomised to the control group will not inform their employer about the online toolbox for a period of six months.
|- Primary outcome||The primary outcome measure of the intervention is the combined outcome measure successful RTW. This outcome measure is a combination of RTW (having performed work activities in own work or in replacement work during the past four weeks) and a subgroup analyses for the ones that did return to work: degrees of successfulness of RTW (a new weighted, on individual level, outcome measure). The degrees of successfulness of RTW contains seven items, which were found to constitute successful RTW most importantly, according to employees diagnosed with cancer: ‘enjoyment in work’, ‘work without sacrificing health’, ‘open communication with employer’, ‘perceived confidence from employer without assumptions about workability’, ‘feeling welcome at work’, ‘good work-life balance’ and ‘joint satisfaction about the work situation (employer and employee)’. Each participant rates each items on its perceived importance and on its success. The combination of the items’ relative perceived importance and the items’ success determines the degrees of successfulness of RTW.|
|- Secondary outcome||Secondary outcome measures are:|
Effectiveness of the intervention:
- Quality of Working life
- Unwanted work changes
- Participation in co-interventions
- Contact with the employer
|- Timepoints||Baseline, before randomisation [T0], after 3 months of follow up [T1] and after six months of follow up [T2].|
|- Trial web site||-|
|- CONTACT FOR PUBLIC QUERIES|| M.A. (Michiel) Greidanus|
|- CONTACT for SCIENTIFIC QUERIES|| M.A. (Michiel) Greidanus|
|- Sponsor/Initiator ||Amsterdam UMC, location Academic Medical Center (AMC), University of Amsterdam (UvA), University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|Dutch Cancer Society (KWF Kankerbestrijding): grant number UVA 2014-7153.|
|- Brief summary||The study will be conducted as a pilot-RCT with a follow up of 6 months. Participants will be randomised to an intervention or a waiting list control group.
The intervention itself targets the employer (i.e. supervisor, HR-manager or case-manager) of the included employee with cancer. The intervention can be seen as a ‘web-based intervention’. This web-based intervention, an online toolbox, is an open access website consisting of supportive information on how to guide employees with cancer throughout different RTW phases. This supportive information consists of to-the-point text and video’s, and targets several actions of the employer, e.g. communicating effectively with the employee with cancer, assessing the employee’s work ability and supporting the employee with cancer emotionally.
The study aims to evaluate the effectiveness of the online toolbox targeting employers on successful RTW of employees with cancer. The online toolbox is considered effective if the intervention group improved significantly more on both components of the primary outcome measure ‘successful RTW’: the number of participant in the intervention group that have returned to work is higher compared with the control group, provided that their degrees of successfulness of RTW is also significantly higher.
|- Main changes (audit trail)|
|- RECORD||30-okt-2018 - 30-nov-2018|