Intervention to support return to work in sick-listed employees with cancer: a randomized controlled trial.

A substantial part of the cancer patients in the Netherlands (65%) stops
working partially orf completely after being diagnosed with cancer. This is
mainly caused by long and/or intensive treatment and the associated residual
complaints like fatigue and cognitive problems. The average leave of absence of
cancer patients worldwide is 151 days. Often a distance arises during the
absence period between the employee with cancer and the workplace, the employer
and the colleagues. The longer employees stay away from the workplace, the
smaller the chance is that they will return to work at all. About six months
after receiving the diagnosis 40% of the patients have returned to work, after
eighteen months the percentage has gone up to 73%. The distance from the
workplace, combined with the changing work abilities after cancer can impede
return to work. This is a large scale issue in the Netherlands; approximately
225.000 people of the working age (18-65) are living with cancer. Within this
group there are 40.000 new cancer diagnoses every year. Because of the
flexibilization of the labor market and the increase of the retirement age,
chances of employees with cancer to return to work are getting smaller. A lot
of cancer patients are very motivated to work, therefore it is necessary to
improve the return to work process of employees with cancer.

To achieve successful return to work, enhancement of the collaboration between
the different actors in the system around the patient is crucial. These actors
are especially: the employer, the occupational physician and the medical
specialist. There is a presumption that the current communication between
employer, occupational physician and the medical specialist is fragmented or
missing at all during the course of treatment. We also know that the
interventions that were executed in the past were not much focused on involving
all the different actors. The professionals involved agree on the fact that a
closer collaboration between the relevant actors involved in the return to work
of an employee with cancer is necessary. However, there is a lack of scientific
rationale or an intervention to stimulate this collaboration. In this study a
new multidisciplinary intervention for return to work of employees with cancer
is researched. The intervention consists of four parts: disease coping (a
psychological process aimed at the coping with illness), SKILLS (the
improvement of one*s personal efficacy and attitude toward work), resource
management (making visible which social support sources are available to the
employee) and a part on exercise. The intervention is overall focused on the
connection between the work-related care and the regular healthcare and the
improvement of the employability of an employee with the goal to have a
successful return to work route. This study is relevant for employees with
cancer, professionals like oncologists, general practitioners and occupational
physicians, employers and insurance companies, investors and science.

The primary objective of this research is to obtain insight in de
(cost-)efficiency of a multidisciplinary intervention focused on the
improvement of return to work after sick leave of employees with cancer.

Specific research questions are:
- Does the use of the intervention alongside the usual care of occupational
care organization *ArboNed* lead to a significant improvement in a) the time
until return to work and b) the quality of life of employees with cancer who
are on sick leave, compared to the usual care?
- If there is a positive effect found, does it lead to cost efficiency?
- To what extent is there a positive effect on secondary outcome measures along
which self-efficacy and quality of life?

In this study, a multidisciplinary intervention is added to the usual care of
absenteeism, as provided by one of the major occupational care organizations in
the Netherlands, which is ArboNed. We evaluate if the intervention leads to an
improvement of workability and if it leads to a significant improvement of the
time until return to work after absenteeism. When we find a positive effect of
the intervention on workability and/or the time until return to work after
absenteeism, we will analyse if this effect is also cost-effective. To research
the (cost)efficacy of the intervention, we conduct a randomized control trial
(RCT) among the research population *employees with cancer who are on sick
leave and are being guided by ArboNed*.

SETTING
The study focuses on employees who are diagnosed with cancer, who are on sick
leave and are therefore being guided by ArboNed. ArboNned, a large organization
supplying work-related care in the Netherlands, has around 300 occupational
physicians, divided in eighteen regional offices. About a hundred of these
occupational physicians who work in de division *insured* are part of this
study. All eighteen regional offices are part of this study, six of them in the
control group and 12 in the intervention group.

In this study the intervention is offered to employees with cancer who are
guided by one of the intervention regional offices of ArboNed. They receive the
usual care as well. The results where it comes to absenteeism and return to
work after absenteeism are being compared to a control group who receive only
the usual care of ArboNed.

DURATION
After joining the study, participants are approximately two years part of the
research group. In this period the participant will be asked to fill in three
questionnaires.

The multidisciplinary intervention is based on and fits in seamlessly with the
recent authorized *Guideline cancer and work* (Richtlijn Kanker en Werk ) from
the Dutch union of occupational physicians (February 2017). The aim of the
guideline is to *restrict unnecessary absence and inflow in disability
benefits/arrangements* by *a better care for the employee with cancer* and to
*increase the quality of life of the employee with cancer*. A core element of
the new guideline is the *joint decision-making* with special attention for the
preference of patients. Furthermore, the occupational physicians use *stepped
and matched care* within the care of an employee with cancer. This means that
the employee is matched to specific interventions and aid workers bases on the
severity and the clinical course of the complaints. The current intervention
wants to structure and support the guideline. This means that in this
intervention the occupational physician will guide the process of return to
work at work and specialized aid workers will match the care. The stepped care
intervention consists of the following steps:

DISEASE COPING: during this step the mental and emotional processing of having
cancer is being watched. If necessary, an active intervention will take place.
RESTORATION OF CONFIDENCE: the confidence of employees with cancer toward
re-integration and dealing with obstacles is being strengthened with help from
the SKILLS-method
RESOURCE MANAGEMENT: in this phase * in which the employee with cancer is at
work * the employee with cancer is being supported in the strengthening of his
competences, autonomy and connectedness (Basic Needs).
EXERCISE: during the intervention the employee with cancer is actively
stimulated to exercise with the intention to improve the physical condition as
much as possible.

The course of the complaints and the illness are being followed and regularly
measured during the intervention. By doing so the next step in the treatment
algorithm (stepped care) can be taken in time. Following this method means both
over- and undertreatment are prevented. The focus of this care from the
occupational physician is mainly aimed at reducing fatigue and psychological
and cognitive problems. This is because:
- Cancer related fatigue is an important symptom that forms an obstruction to
return to work for employees diagnosed with cancer. The fatigue often becomes a
chronical issue. For example, approximately 1/3 of the treated breast cancer
patients suffer from fatigue, even though the prognoses to recovery is good.
These complaints effect the quality of life, the daily functioning and the time
it takes for someone to return to work.
- Cognitive problems often occur in employees with cancer who had to undergo
chemotherapy (chemobrain/chemofog). Just like the fatigue, the cognitive
problems can continue for a long time after treatment. Cognitive problems
differ per type of cancer. Employees with a brain tumor suffer from cognitive
problems in 90% of the cases, leukemia only causes cognitive problems in 20-30%
of the cases and breast cancer approximately 75%.
- Psychological complaints in the form of anxiety and depression are factors
that obstruct return to work and they are relatively common among employees
with cancer. In a recent study about the prevalence of anxiety and depression
in more than 10.000 patients with the diagnosis cancer appeared that 13% of the
patients had clinical manifested depression and 19% of the patients had
clinical manifested anxiety. The percentages subclinical manifested depression
and anxiety were respectively 17% and 23%.

The intervention describes an innovative approach on return after work after
absence as a consequence of cancer. Furthermore, this intervention is being
adjusted to the different phases in curative and work-related care, i.e. the
treatment-, recovery-, and re-integration phase.

The occupational physician plays the role of process consultant during the
intervention. Besides that, the occupational physician will hold his regular
consulting hours (which are also required by law) and he will have a
multidisciplinary meeting at the end of the cancer treatment, which will be the
beginning of returning to work. In the multidisciplinary meeting the employee
with cancer, the manager, and the occupational physician will be present to
discuss return to work. This session is repeated when the employee with cancer
has been fully returned to work. The occupational physician will also consult
the oncologist and they will exchange information. This happens at the
beginning and at the end of the intervention.

The activities in the intervention are aimed at improving the workability and
reducing fatigue, cognitive problems and psychological problems. The
intervention consist of a maximum of six sessions disease coping* in which the
*dual process model of coping can be used, a maximum of five sessions SKILLS
and a maximum of six sessions *resource management* based on the
self-determination theory of Deci & Ryan. Exercise will be a subject within
every session.

DISEASE COPING
The disease coping module consist of a maximum of six sessions distributed
across a maximum of 24 weeks. The aim of this module is to detect the
development of depression and anxiety in an early stage of the cancer treatment
and stop progression of depression and anxiety. When the first signals arise
the *dual process of coping* by Stroebe and Schut is used, of course in
agreement with the participant. In this method, there are two ways of coping
with stress and loss. First there is the *loss-orientation*, in which coping is
directly focused on the stress that arises because of the loss. Then there is
the *restoration-orientation* which refers to the process in which someone
tries to deal with the stress compared to a new role, identity or new tasks.
This last orientation improves self-efficacy, self-confidence, independence and
autonomy to arrange ones daily life in a good way. Besides that, this approach
supports personal growth and the ability to learn new skills. This method is
already being used for different types of grief and sadness, but it has not
been used for cancer patients. The rationale of this method is that it not only
teaches someone how to deal with the stress that is involved in (the treatment
of) cancer, but also with aspects of loss and emotion regulation.

SKILLS
The intervention part SKILLS consists of a maximum of five session distributed
across five weeks. This part is executed by the corporate social worker or a
reintegration coach of Re-turn. This is decided by availability. The aim of
this part is to strengthen the confidence patients have in their return to
work. Different studies in the field of work related (psychological) complaints
and return to work show that trust in one*s own abilities is an important
predictor for the speed of return to work. SKILLS is derived from a group
approach for people with a distance to the labor market and has been applied to
people seeking a job and people with a chronic condition. SKILLS is based on
strengthening the confidence in one*s own abilities and dealing with setbacks.
It is a very powerful and proven effective method, with long-term effects. The
corporate social workers of ArboNed and the reintegration coaches of Re-turn
are going to be trained in the SKILLS-protocol prior to the start of the study.

RESOURCE MANAGEMENT
The resource-management, i.e. the managing of resources in the form of Basic
Needs Satisfaction is the third step off stepped care. This module is executed
by Re-turn. The goal of this part of the intervention is to get employees with
cancer more motivated to show healthy behavior and to persevere and expand work
resumption. The Basic Need Satisfaction finds its scientific base in the Self
Determination Theory by Deci & Ryan. This theory assumes that a behavioral
change is more effective if patients (and therefore also employees with cancer)
are more autonomously (intrinsically motivated. A meta-analysis on the
application of this theory in healthcare has shown that when the psychological
basic needs (competence, autonomy and relatedness) of a patient are more
satisfied, the motivation to show healthy behavior (for example *working*)
becomes stronger and more intrinsic.

EXERCISE
At this moment there is enough evidence that exercising has a positive effect
on the quality of life of employees with cancer. Exercise reduces the fatigue
that arises during and after the cancer treatment in an effective way. The most
important goal of the intervention is to make sure that employees with cancer *
when possible - exercise 150 minutes a week in a moderate to intensive way,
distributed across 3-5 days a week. Exercising more does not seem to have an
effect. Besides that, the fact that exercises based on yoga have a positive
effect on the cognitive problems that can arise during the cancer treatment
will be emphasized. The amount of exercise of a participant will be discussed
briefly in every session.

All the sessions of the intervention will be held according to the Stress
Inoculation Training method of Meichenbaum. The session begins with a
conceptualization (which thoughts and experiences had an employee with cancer
in certain situations), followed by discussing the right (coping) strategy to
manage these thoughts and experiences. This strategy will be practiced and
after that the session will be ended with an assignment for everyday life.

Participants in the control group receive usual care, and are asked to complete
three questionnaires in a two-year time period. Participants in the
intervention group are also asked to complete three questionnaires and they
receive usual care + the intervention. The intervention consists of 17 sessions
of 1.5 hours each, offered in line with the treatment and recovery plan of the
patient. The intervention components have been offered in previous settings
before, but were not evaluated in scientific studies. No adverse effects are
known to have come forth from these sessions. All in all, we consider the risks
and burden for participants very low, particularly as many cancer patients are
known to participate in additional courses or rehabilitation programs alongside
usual care, with no adverse effects in general.