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:
Univ Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Prudenzi, Arianna
Jadhakhan, Feroz
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Univ Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Jadhakhan, Feroz
Gill, Kiranpreet
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机构:
Univ Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Gill, Kiranpreet
MacArthur, Michael
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机构:
Univ Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
MacArthur, Michael
Patel, Krishane
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机构:
Univ Warwick, Sch Engn, Warwick Mfg Grp WMG, Coventry, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Patel, Krishane
Moukhtarian, Talar
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h-index: 0
机构:
Univ Warwick, Warwick Med Sch, Mental Hlth & Wellbeing Unit, Coventry, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Moukhtarian, Talar
Kershaw, Charlotte
论文数: 0引用数: 0
h-index: 0
机构:
Univ Warwick, Warwick Med Sch, Mental Hlth & Wellbeing Unit, Coventry, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Kershaw, Charlotte
Norton-Brown, Errin
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机构:
Community Programmes Team, London, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Norton-Brown, Errin
Johnston, Naomi
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机构:
Community Programmes Team, London, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Johnston, Naomi
Daly, Guy
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机构:
Coventry Univ, Fac Hlth & Life Sci, Coventry, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Daly, Guy
Russell, Sean
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机构:
Coventry Univ, Fac Hlth & Life Sci, Coventry, W Midlands, England
West Midlands Combined Author, Birmingham, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Russell, Sean
Thomson, Louise
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机构:
Univ Nottingham, Ctr Org Hlth & Dev, Sch Med, Nottingham, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Thomson, Louise
Munir, Fehmidah
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h-index: 0
机构:
Loughborough Univ, Sch Sport Exercise & Hlth Sci, Loughborough, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Munir, Fehmidah
Blake, Holly
论文数: 0引用数: 0
h-index: 0
机构:
Univ Nottingham, Sch Hlth Sci, Nottingham, England
NIHR Nottingham Biomed Res Ctr, Nottingham, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Blake, Holly
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Meyer, Caroline
Marwaha, Steven
论文数: 0引用数: 0
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机构:
Univ Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
Birmingham & Solihull Mental Hlth NHS Fdn Trust, Zinnia Ctr, Specialist Mood Disorders Clin, Birmingham, W Midlands, EnglandUniv Birmingham, Inst Mental Hlth, Coll Life & Environm Sci, Sch Psychol, Birmingham, W Midlands, England
机构:
Univ Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, France
SIRIC ONCOLille, F-59000 Lille, FranceUniv Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, France
Vidor, Clemence
Leroyer, Ariane
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h-index: 0
机构:
Univ Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, FranceUniv Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, France
Leroyer, Ariane
Christophe, Veronique
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h-index: 0
机构:
Univ Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, FranceUniv Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, France
Christophe, Veronique
Seillier, Melanie
论文数: 0引用数: 0
h-index: 0
机构:
Univ Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, France
Caisse Assurance Retraite & Sante Travail CARSAT, F-59662 Villeneuve Dascq, FranceUniv Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, France
Seillier, Melanie
Foncel, Jerome
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机构:
Univ Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, FranceUniv Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, France
Foncel, Jerome
Van de Maele, Justine
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h-index: 0
机构:
Univ Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, France
SIRIC ONCOLille, F-59000 Lille, FranceUniv Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, France
Van de Maele, Justine
Bonneterre, Jacques
论文数: 0引用数: 0
h-index: 0
机构:
Ctr Oscar Lambret, F-59020 Lille, FranceUniv Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, France
Bonneterre, Jacques
Fantoni, Sophie
论文数: 0引用数: 0
h-index: 0
机构:
Univ Lille Nord France, CRDPD LEREDS EA 4487, F-59037 Lille, FranceUniv Lille 3, Univ Lille Nord France, Unite Rech Sci Cognit & Affect URECA, EA 1059, F-59653 Villeneuve Dascq, France
机构:
Inst Clin Sci, Sch Dent, Periodontal Res Grp, Birmingham B5 7EG, W Midlands, England
Univ Birmingham, Coll Med & Dent Sci, Birmingham B5 7EG, W Midlands, England
Birmingham Community Healthcare NHS Fdn Trust, Birmingham B5 7EG, W Midlands, EnglandInst Clin Sci, Sch Dent, Periodontal Res Grp, Birmingham B5 7EG, W Midlands, England
Sharma, Praveen
Cockwell, Paul
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h-index: 0
机构:
Univ Hosp Birmingham, Dept Renal Med, Birmingham B15 2GW, W Midlands, EnglandInst Clin Sci, Sch Dent, Periodontal Res Grp, Birmingham B5 7EG, W Midlands, England
Cockwell, Paul
Dietrich, Thomas
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h-index: 0
机构:
Univ Birmingham, Coll Med & Dent Sci, Birmingham B5 7EG, W Midlands, England
Birmingham Community Healthcare NHS Fdn Trust, Birmingham B5 7EG, W Midlands, England
Inst Clin Sci, Sch Dent, Dept Oral Surg, Birmingham B5 7EG, W Midlands, EnglandInst Clin Sci, Sch Dent, Periodontal Res Grp, Birmingham B5 7EG, W Midlands, England
Dietrich, Thomas
Ferro, Charles
论文数: 0引用数: 0
h-index: 0
机构:
Univ Hosp Birmingham, Dept Renal Med, Birmingham B15 2GW, W Midlands, EnglandInst Clin Sci, Sch Dent, Periodontal Res Grp, Birmingham B5 7EG, W Midlands, England
Ferro, Charles
Ives, Natalie
论文数: 0引用数: 0
h-index: 0
机构:
Inst Appl Heath Res, Birmingham Clin Trials Unit BCTU, Birmingham B15 2TT, W Midlands, EnglandInst Clin Sci, Sch Dent, Periodontal Res Grp, Birmingham B5 7EG, W Midlands, England
Ives, Natalie
Chapple, Iain L. C.
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h-index: 0
机构:
Inst Clin Sci, Sch Dent, Periodontal Res Grp, Birmingham B5 7EG, W Midlands, England
Univ Birmingham, Coll Med & Dent Sci, Birmingham B5 7EG, W Midlands, England
Birmingham Community Healthcare NHS Fdn Trust, Birmingham B5 7EG, W Midlands, EnglandInst Clin Sci, Sch Dent, Periodontal Res Grp, Birmingham B5 7EG, W Midlands, England
机构:
Natl Univ Singapore, Yong Loo Lin Sch Med, Alice Lee Ctr Nursing Studies, Singapore, SingaporeSingapore Gen Hosp, Dept Colorectal Surg, Singapore, Singapore