The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial
Work;
Cancer;
Employee;
Employer;
Manager;
Cancer survivors;
Clinical trial protocol;
Return to work;
Pilot randomised controlled trial protocol;
Intervention;
BREAST-CANCER;
META-SYNTHESIS;
TO-WORK;
SURVIVORS;
DISABILITY;
EXPERIENCES;
COMPLEX;
QUALITY;
LIFE;
D O I:
10.1186/s13063-020-04288-0
中图分类号:
R-3 [医学研究方法];
R3 [基础医学];
学科分类号:
1001 ;
摘要:
BackgroundEmployers express a need for support to facilitate the return to work (RTW) process of employees with cancer. We have developed the MiLES intervention, an online toolbox targeting employers during the RTW of employees with cancer. To evaluate the MiLES intervention, we propose the design of a pilot randomised controlled trial (RCT). The aim of this pilot is to determine whether a future RCT to study the effectiveness of this intervention on successful RTW of employees with cancer is feasible. Secondary aims are to obtain preliminary results on the effectiveness of the intervention and to determine the sample size needed in a future definitive RCT.MethodsA pilot RCT with a 6-month follow-up will be conducted. Using medical specialists at Dutch hospitals, we aim to enrol 90 participants diagnosed with cancer (<2years earlier) aged 18-63years who are in paid employment with an employer and who are currently sick-listed or partly sick-listed for <1year. Participants randomised to the intervention group will be asked to inform their employer about the online toolbox supporting employers during the RTW process of employees with cancer. Participants in the control group will receive 'care as usual' from their employer. All measures will be assessed at the level of the employee using questionnaires at baseline and after 3 and 6 months of follow-up. The feasibility of a future RCT will be determined using criteria concerning method-related uncertainties and acceptability of the study protocol. The primary effect measure will be successful RTW (that is, RTW perceived as being successful by the cancer survivor themselves). This effect measure will be used to perform the sample size calculation for a future definitive RCT.DiscussionThe design is proposed to determine the feasibility to study the effectiveness of the MiLES intervention targeting employers on the successful RTW of employees diagnosed with cancer. This pilot RCT can increase the probability of a successful future definitive RCT on the effectiveness of the intervention and potentially obviate the need to carry out an unfeasible and resource-intensive study.
机构:
Kings Coll London, Dent Practice & Policy Dept, Unit Social & Behav Sci, Inst Dent, London SE5 9RW, EnglandKings Coll London, Dent Practice & Policy Dept, Unit Social & Behav Sci, Inst Dent, London SE5 9RW, England
Scott, Suzanne E.
Khwaja, Mahrukh
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Kings Coll London, Dent Practice & Policy Dept, Unit Social & Behav Sci, Inst Dent, London SE5 9RW, EnglandKings Coll London, Dent Practice & Policy Dept, Unit Social & Behav Sci, Inst Dent, London SE5 9RW, England
Khwaja, Mahrukh
Low, Emma L.
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UCL, Dept Epidemiol & Publ Hlth, London, EnglandKings Coll London, Dent Practice & Policy Dept, Unit Social & Behav Sci, Inst Dent, London SE5 9RW, England
Low, Emma L.
Weinman, John
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Kings Coll London, Inst Psychiat, London WC2R 2LS, EnglandKings Coll London, Dent Practice & Policy Dept, Unit Social & Behav Sci, Inst Dent, London SE5 9RW, England
Weinman, John
Grunfeld, Elizabeth A.
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Kings Coll London, Inst Psychiat, London WC2R 2LS, EnglandKings Coll London, Dent Practice & Policy Dept, Unit Social & Behav Sci, Inst Dent, London SE5 9RW, England
机构:
Univ New S Wales, S Western Sydney Clin Sch, Ingham Inst Appl Med Res, Translat Canc Res Unit,UNSW Med, Liverpool, BC NSW 2170, AustraliaUniv New S Wales, S Western Sydney Clin Sch, Ingham Inst Appl Med Res, Translat Canc Res Unit,UNSW Med, Liverpool, BC NSW 2170, Australia
Lambert, Sylvie D.
Girgis, Afaf
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Univ New S Wales, S Western Sydney Clin Sch, Ingham Inst Appl Med Res, Translat Canc Res Unit,UNSW Med, Liverpool, BC NSW 2170, AustraliaUniv New S Wales, S Western Sydney Clin Sch, Ingham Inst Appl Med Res, Translat Canc Res Unit,UNSW Med, Liverpool, BC NSW 2170, Australia
Girgis, Afaf
Turner, Jane
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Univ Queensland, Mental Hlth Ctr, Herston, Qld 4029, AustraliaUniv New S Wales, S Western Sydney Clin Sch, Ingham Inst Appl Med Res, Translat Canc Res Unit,UNSW Med, Liverpool, BC NSW 2170, Australia
Turner, Jane
McElduff, Patrick
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Univ Newcastle, Sch Med & Publ Hlth, New Lambton, NSW 2305, AustraliaUniv New S Wales, S Western Sydney Clin Sch, Ingham Inst Appl Med Res, Translat Canc Res Unit,UNSW Med, Liverpool, BC NSW 2170, Australia
McElduff, Patrick
Kayser, Karen
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机构:
Univ Louisville, Kent Sch Social Work, Louisville, KY 40292 USAUniv New S Wales, S Western Sydney Clin Sch, Ingham Inst Appl Med Res, Translat Canc Res Unit,UNSW Med, Liverpool, BC NSW 2170, Australia
Kayser, Karen
Vallentine, Paula
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NSW Canc Council, Woolloomooloo, NSW 2011, AustraliaUniv New S Wales, S Western Sydney Clin Sch, Ingham Inst Appl Med Res, Translat Canc Res Unit,UNSW Med, Liverpool, BC NSW 2170, Australia