Trial design
The study is a controlled trial conducted on cancer survivors treated at the Oncology Department, Aarhus University Hospital, Denmark with a 12 months follow-up.
Participants
Intervention group
Cancer patients diagnosed with breast, colon-rectal, head and neck, thyroid gland, testicular, ovarian or cervix cancer referred to surgery, radiotherapy or chemotherapy at the Oncology Department at Aarhus University Hospital. Patients must be residents in the municipalities of Silkeborg or Randers, be at the age of 18–60 years and have a permanent or temporary employment (with at least 6 months left of their contract) at the inclusion date. Patients are eligible for participation whether they are still working or being on sick leave.
Patients, for whom the treating physician considers occupational rehabilitation to be unethical, or who are not reading or talking Danish are excluded.
Recruitment started in December 2013 and continues until the required sample size is obtained.
Control group
The control group is defined by patients with identical inclusion and exclusion criteria as the intervention group except that they live in other municipalities than Silkeborg and Randers.
The control group is identified via the electronic patient records at the Aarhus University Hospital.
Recruitment of the intervention group participants
Patients are recruited to the intervention group in a three-stage process:
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1)
At each cancer ward a nurse or assistant nurse assigned to this project identifies patients living in Randers or Silkeborg municipality with the eligible cancer diagnosis.
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2)
The treating oncologist is notified of this patient and at first given consultation the patient is informed about the project, is handed a written information sheet also containing an informed written consent formula. The patient is asked to read the information sheet and is informed that a municipal job consultant will contact the patient at home by phone.
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2a)
The municipal job consultant may also identify eligible patients even before cancer treatment has begun because of sick leave spells exceeding 8 weeks. In that case the treating hospital ward is notified about inclusion status; in that way no cancer survivor is asked twice about inclusion.
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3)
Finally the patient is telephoned by the municipal job consultant, who thoroughly informs the patient about the project. Participation includes the patients’ willingness to involve next of kin, employer, and colleagues. If the patient accepts participation the first meeting is set up and the informed written consent formula is signed on that occasion.
Intervention
Control group
Cancer survivors in the control group will receive the usual municipal sickness benefit management within their municipal of residence as described in the background.
Intervention group
In both intervention municipalities the two job consultants attended a 4-days course in which they were specially trained by a psychologist in using elements of the Acceptance and Commitment Therapy (ACT) [23, 47] and the Individual Placement and Support Model (IPS) [48, 49].
During the inclusion- and intervention period the job consultants receive supervision by this psychologist once every month to secure a high degree of compliance with the intervention protocol.
Acceptance commitment and therapy
ACT is a development of cognitive behaviour therapy, which is based on recognition of the person’s values and immediate needs in current life situation. The goal of ACT is to increase psychological flexibility, which can be defined as the ability to contact the present moment more fully as a conscious human being, and to change or persist in behaviour that support one’s own values. Psychological flexibility is established through six core ACT processes: acceptance, cognitive fusion, being present, self as context, values, and committed action. Each of these areas is conceptualized as a positive psychological skill. The survivors are through dialogue with the job consultant confronted with these six core elements in order to enhance commitment and change in behaviour towards RTW [23].
Individual placement and support
The IPS inspired the way the job consultants systematize the actions by which they support RTW. The model originates from helping people with severe psychiatric illness to engage in paid employment, and builds on the following key elements: integration at the workplace, paid work, individualized services, and an ongoing individualised support [48, 49]. In this intervention the individualised support is “operationalised” in a number of phases, which correspond to the R-RTW obtained stages of change, i.e. a set of IPS-inspired actions are initiated according to the defined stage in which the survivor perceives him-/herself to be in: Pre-contemplation, Contemplation, Preparation for action - self-evaluative, Prepared for action – behavioural, Uncertain maintenance, or Proactive maintenance.
Assessment of occupational rehabilitation needs
At the first meeting with the job consultant the cancer survivor is asked to answer an online questionnaire. The questionnaire data is used to guide the job consultant regarding the cancer survivor’s readiness for RTW and need of support in order to set up an individual RTW plan. Hence, the ACT inspired dialogue and the systematic occupational needs assessment are integrated in the IPS phases by which the job consultant supports the survivor’s RTW-process (Fig. 1). The job consultant sets up meetings with the cancer survivor according to the RTW plan. Throughout the intervention the rehabilitation plan is adjusted to the survivors’ needs, actual resources and readiness for RTW. The initial rehabilitation plan and the subsequent actions and adjustments are registered online alongside the questionnaire data by the job consultants.
The intervention continues for a maximum of one year or until RTW. The survivor answers the Readiness for RTW scale after three months and at one-year follow up.
Online questionnaire
Co-morbidity
Eighteen co-morbidity questions asking whether the respondent suffer from or has suffered from (asthma, allergies, diabetes, hypertension, coronary thrombosis, angina, cerebral thrombosis, chronic obstructive pulmonary disease, osteoarthritis, rheumatoid arthritis, osteoporosis, cancer, migraine, minor psychiatric disorder, major psychiatric disorder, herniated disc or other back disorders, cataract, tinnitus). There are four response categories (no/never, yes/present, yes/previously, if previously yes - do you have any late complications?). Number of co-morbidities are counted if present or previously present and give late complications [50, 51].
Work intention
One question about intention to work (i) in your estimation, what are the chances that you will be able to work in six months?” measured with a 10-point rating scale ranging from 1 (no chance) to 10 (very large chance) [52].
Self-efficacy
The seven-item general self-efficacy scale from The Copenhagen Psychosocial Questionnaire (COPSOQ) (i) I can always manage to solve difficult problems if I try hard enough, (ii) if someone opposes me, I can find the ways and means to get what I want, (iii) I am certain that I can accomplish my goals, (iv) thanks to my resourcefulness, I can handle unforeseen situations, (v) I can remain calm when facing difficulties because I can rely on my coping abilities, (vi) when I am confronted with a problem, I can find several solutions, (vii) I can handle whatever comes my way. The response categories are (not at all true, barely true, moderately true, and exactly true) which were scored from 0–100 with 100 representing the highest degree of self-efficacy [53].
Social support
From the 2nd version of COPSOQ, three items about social support from colleagues and supervisors, respectively; (i) how often do you get help and support from your colleagues?, (ii) how often are your colleagues willing to listen to your problems at work?, (iii) how often do your colleagues talk with you about how well you carry out your work? and (i) how often is your nearest superior willing to listen to your problems at work?, (ii) how often do you get help and support from your nearest superior?, (iii) how often does your nearest superior talk with you about how well you carry out your work?. The response categories are (always; often; sometimes; seldom; never/hardly ever; not relevant, which are scored from 0–100 with 100 representing the highest degree of support [54].
Readiness for RTW
Finally, the Readiness for RTW will be measured by the Danish version of the original R-RTW scale [40]. The instrument consists of two scales; 22 items for persons not yet returned to work: (i) you do not think you will ever be able to go back to work?, (ii) you have been making plans with someone from your workplace to return back to work?, (iii) you have been thinking about making some changes that will help you go back to work?, (iv) as far as you are concerned there is no point in thinking about returning to work?, (v) you have learned different ways to cope with your pain so you can return to work?, (vi) you are actively doing things now to get back to work?, (vii) you think you might be ready to go back to work?, (viii) you are planning to go back to work, even if your pain is not 100 % gone?, (ix) physically, you are starting to feel ready to go back to work?, (x) you have been increasing your activities at home in order to build up your strength to go back to work?, (xi) you are getting help from others to return to work?, (xii) you are not ready to go back to work?, (xiii) you have found strategies to make your work manageable so you can return to work?, (xiv) mentally, you are starting to feel ready to go back to work?, (xv) you have been wondering if there is something you could do to return to work?, (xvi) you worry about having to stop working again due to your injury?, (xvii) you have started thinking about going back to work”?, (xviii) you have a date for your first day back at work?, (xix) you wonder if you will be able to go back to work?, (xx) you wish you had more ideas about how to get back to work?, (xxi) you would like to have some advice about how to go back to work?, (xxii) as far as you are concerned, you do not need to go back to work ever”?.
And a scale with 12 items for those who have returned to work (part-time or full-time), but are at risk of sickness absence relapse: (i) you are trying different strategies to stay at work?, (ii) you are doing everything you can to stay at work?, (iii) you are getting help from others to stay at work?, (iv) you are working hard to find ways to cope with the difficulties of being back at work?, (v) you have learned different ways to cope with your pain so that you can stay at work?, (vi) you are taking steps to prevent having to go off job again due to your injury?, (vii) you have found strategies to make your work manageable so you can stay at work?, (viii) you are back at work but are not sure you can keep up the effort?, (ix) you worry about having to stop working again due to your injury?, (x) you still find yourself struggling to stay at work due to the effects of your injury?, (xi) you are back at work and it is going well?, (xii) you feel you may need help in order to stay at work?. Each item is scored on a five point ordinal scale (1 = strongly disagree) to (5 = strongly agree). Mean scores are calculated and forms four underlying stages for those not returned to work: Precontemplation, Contemplation, Preparation for action - self-evaluative, and Prepared for action - behavioural. And two stages for those already returned to work: Uncertain maintenance and proactive maintenance. The stage obtaining the highest mean score is interpreted as the current stage of readiness. The score of the R-RTW scale is immediately calculated in the online questionnaire. Measurements will be repeated after three and twelve months.
Outcomes
Primary
The primary outcome is RTW among cancer survivors in the intervention group compared with the control group.
RTW is defined by at least 4 consecutive weeks of no social transfer payments or attending a modified job called “flexi job”.
The outcome is identified in a national register on weekly public transfer payments called the Danish Register for Evaluation of Marginalisation (DREAM) which has been found to provide valid information on labour market outcomes [55, 56]. Four consecutive weeks of no social transfer payments are considered to be equivalent to RTW along with four consecutive weeks of transfer payment equivalent to attending a “flexi job”.
Secondary
The secondary outcomes are whether socioeconomic status or co-morbidity is modifying the effect of the intervention on RTW.
Socioeconomic status is defined by type of work, educational level and last year household income before taxes, which are collected from Statistics Denmark [57].
Co-morbidity is defined by the Charlson-index; a weighted index including the number and seriousness of co-morbid diseases [58]. Data on diagnosis used in the Charlson-index are collected from the National Patient Registry in Denmark [59].
Sample size calculation
The sample size calculation is based on the primary outcome RTW.
Approximately 450 patients are annually referred to the oncology ward with the eligible cancer diagnosis of which 20 % reside in the two intervention municipalities. It is expected that the employment rate among cancer patients would correspond to that of the Danish background population equivalent to approximately 80 % [60]. Furthermore, it was anticipated that 80 % gave informed consent to participate in the study. Hence, an expected number of 288 cancer patients per year. We estimated a mortality rate of 10 % during the one-year follow-up. Based on previous studies the RTW rate among cancer survivors who underwent occupational rehabilitation is approximately 82 % [18], and that the share will be approximately 60 % in the control group [61, 62]. The hazard ratio (HR) is then given by: (HR: ln (40 %) / ln (18 %) = 1.87). With a power of 90 % and a significance level of 5 % a required sample size of 290 patients is needed. To obtain sufficient strength in the adjusted analyzes 250 survivors should RTW. Thus, the total number of cancer survivors required is 430 (of which 90 reside in the two intervention municipalities) which means an inclusion period of 1.5 years.
Statistical analyses
Primary outcome
The cumulative incidence proportion (CIP) as a function of the number of follow-up weeks is estimated using the Kaplan-Meier curve. The relative cumulative incidence of RTW within 52 weeks will be analyzed in a generalised linear regression model using the pseudo values method [63, 64].
Entry time is defined as the end of cancer treatment (identified from the hospital records) and the end of follow-up is 52 weeks following entry time. The outcome variable RTW consists of two measures: an event indicator (yes or no) and the time until RTW is identified in the DREAM register [65] or end of follow-up / competing risks (early retirement benefit, retirement pension or death)/censored observations (emigration), whichever comes first.
Adjustments for gender, age, cancer diagnosis, time since diagnosis and Charlson’s co-morbidity index [58] are going to be carried out. Moreover, analyses of whether socio-economic status or Charlson’s co-morbidity index modifies the effect of the intervention on RTW will also be carried out.
The significance level is set at p < 0.05. The results will be shown as crude and adjusted relative cumulative incidences, i.e. risks (RR) and corresponding 95 % confidence intervals (95 % CI).
STATA version 13.1 will be used as statistical software.
Ethical considerations
The study has been notified to and registered by the Danish Data Protection Agency (nr. 1-16-02-657-14). Approval from the Danish National Committee on Biomedical Research Ethics was not relevant as this is only provided for projects using biological material. Furthermore, the present study does not include biomedical treatment.
All patients provided informed consent prior to inclusion in the study.