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      Enhancing return-to-work in cancer patients, development of an intervention and design of a randomised controlled trial

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          Abstract

          Background

          Compared to healthy controls, cancer patients have a higher risk of unemployment, which has negative social and economic impacts on the patients and on society at large. Therefore, return-to-work of cancer patients needs to be improved by way of an intervention. The objective is to describe the development and content of a work-directed intervention to enhance return-to-work in cancer patients and to explain the study design used for evaluating the effectiveness of the intervention.

          Development and content of the intervention

          The work-directed intervention has been developed based on a systematic literature review of work-directed interventions for cancer patients, factors reported by cancer survivors as helping or hindering their return-to-work, focus group and interview data for cancer patients, health care professionals, and supervisors, and vocational rehabilitation literature. The work-directed intervention consists of: 1) 4 meetings with a nurse at the treating hospital department to start early vocational rehabilitation, 2) 1 meeting with the participant, occupational physician, and supervisor to make a return-to-work plan, and 3) letters from the treating physician to the occupational physician to enhance communication.

          Study design to evaluate the intervention

          The treating physician or nurse recruits patients before the start of initial treatment. Patients are eligible when they have a primary diagnosis of cancer, will be treated with curative intent, are employed at the time of diagnosis, are on sick leave, and are between 18 and 60 years old. After the patients have given informed consent and have filled out a baseline questionnaire, they are randomised to either the control group or to the intervention group and receive either care as usual or the work-directed intervention, respectively. Primary outcomes are return-to-work and quality of life. The feasibility of the intervention and direct and indirect costs will be determined. Outcomes will be assessed by a questionnaire at baseline and at 6, 12, 18, and 24 months after baseline.

          Discussion

          This study will provide information about the effectiveness of a work-directed intervention for cancer patients. The intention is to implement the intervention in normal care if it has been shown effective.

          Trial registration

          NTR1658

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          Most cited references21

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          Cancer survivors and unemployment: a meta-analysis and meta-regression.

          Nearly half of adult cancer survivors are younger than 65 years, but the association of cancer survivorship with employment status is unknown. To assess the association of cancer survivorship with unemployment compared with healthy controls. A systematic search of studies published between 1966 and June 2008 was conducted using MEDLINE, CINAHL, EMBASE, PsycINFO, and OSH-ROM databases. Eligible studies included adult cancer survivors and a control group, and employment as an outcome. Pooled relative risks were calculated over all studies and according to cancer type. A Bayesian meta-regression analysis was performed to assess associations of unemployment with cancer type, country of origin, average age at diagnosis, and background unemployment rate. Twenty-six articles describing 36 studies met the inclusion criteria. The analyses included 20,366 cancer survivors and 157,603 healthy control participants. Studies included 16 from the United States, 15 from Europe, and 5 from other countries. Overall, cancer survivors were more likely to be unemployed than healthy control participants (33.8% vs 15.2%; pooled relative risk [RR], 1.37; 95% confidence interval [CI], 1.21-1.55). Unemployment was higher in breast cancer survivors compared with control participants (35.6% vs 31.7%; pooled RR, 1.28; 95% CI, 1.11-1.49), as well as in survivors of gastrointestinal cancers (48.8% vs 33.4%; pooled RR, 1.44; 95% CI, 1.02-2.05), and cancers of the female reproductive organs (49.1% vs 38.3%; pooled RR, 1.28; 95% CI, 1.17-1.40). Unemployment rates were not higher for survivors of blood cancers compared with controls (30.6% vs 23.7%; pooled RR, 1.41; 95% CI, 0.95-2.09), prostate cancers (39.4% vs 27.1%; pooled RR, 1.11; 95% CI, 1.00-1.25), or testicular cancer (18.5% vs 18.1%; pooled RR, 0.94; 95% CI, 0.74-1.20). For survivors in the United States, the unemployment risk was 1.5 times higher compared with survivors in Europe (meta-RR, 1.48; 95% credibility interval, 1.15-1.95). After adjustment for diagnosis, age, and background unemployment rate, this risk disappeared (meta-RR, 1.24; 95% CI, 0.85-1.83). Cancer survivorship is associated with unemployment.
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            The utility of 'country of birth' for the classification of ethnic groups in health research: the Dutch experience.

            The relationship between ethnicity and health is attracting increasing attention in international health research. Different measures are used to operationalise the concept of ethnicity. Presently, self-definition of ethnicity seems to gain favour. In contrast, in the Netherlands, the use of country of birth criteria have been widely accepted as a basis for the identification of ethnic groups. In this paper, we will discuss its advantages as well as its limitations and the solutions to these limitations from the Dutch perspective with a special focus on survey studies. The country of birth indicator has the advantage of being objective and stable, allowing for comparisons over time and between studies. Inclusion of parental country of birth provides an additional advantage for identifying the second-generation ethnic groups. The main criticisms of this indicator seem to refer to its validity. The basis for this criticism is, firstly, the argument that people who are born in the same country might have a different ethnic background. In the Dutch context, this limitation can be addressed by the employment of additional indicators such as geographical origin, language, and self-identified ethnic group. Secondly, the country of birth classification has been criticised for not covering all dimensions of ethnicity, such as culture and ethnic identity. We demonstrate in this paper how this criticism can be addressed by the use of additional indicators. In conclusion, in the Dutch context, country of birth can be considered a useful indicator for ethnicity if complemented with additional indicators to, first, compensate for the drawbacks in certain conditions, and second, shed light on the mechanisms underlying the association between ethnicity and health.
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              The Work Limitations Questionnaire.

              The objective of this work was to develop a psychometrically sound questionnaire for measuring the on-the-job impact of chronic health problems and/or treatment ("work limitations"). Three pilot studies (focus groups, cognitive interviews, and an alternate forms test) generated candidate items, dimensions, and response scales. Two field trials tested the psychometric performance of the questionnaire (studies 1 and 2). To test recall error, study 1 subjects were randomly assigned to 2 different questionnaire groups, a questionnaire with a 4-week reporting period completed once or a 2-week version completed twice. Responses were compared with data from concurrent work limitation diaries (the gold standard). To test construct validity, we compared questionnaire scores of patients with those of healthy job-matched control subjects. Study 2 was a cross-sectional mail survey testing scale reliability and construct validity. The study subjects were employed individuals (18-64 years of age) from several chronic condition groups (study 1, n = 48; study 2, n = 121) and, in study 1, 17 healthy matched control subjects. Study 1 included the assigned questionnaires and weekly diaries. Study 2 included the new questionnaire, SF-36, and work productivity loss items. In study 1, questionnaire responses were consistent with diary data but were most highly correlated with the most recent week. Patients had significantly higher (worse) limitation scores than control subjects. In study 2, 4 scales from a 25-item questionnaire achieved Cronbach alphas of > or = 0.90 and correlated with health status and self-reported work productivity in the hypothesized manner (P < or = 0.05). With 25 items, 4 dimensions (limitations handling time, physical, mental-interpersonal, and output demands), and a 2-week reporting period, the Work Limitations Questionnaire demonstrated high reliability and validity.
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                Author and article information

                Journal
                BMC Cancer
                BMC Cancer
                BioMed Central
                1471-2407
                2010
                1 July 2010
                : 10
                : 345
                Affiliations
                [1 ]Coronel Institute of Occupational Health, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
                [2 ]Finisch Institute of Occupational Health Field, Kuopio, Finland
                [3 ]Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK
                Article
                1471-2407-10-345
                10.1186/1471-2407-10-345
                2907345
                20594347
                c5b2017b-fd4c-4fd4-8cbe-02259430b263
                Copyright ©2010 Tamminga et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 19 March 2010
                : 1 July 2010
                Categories
                Study Protocol

                Oncology & Radiotherapy
                Oncology & Radiotherapy

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