(1) To evaluate the (cost-)effectiveness of an individual rehabilitation program on RTW and continuation of work in cancer patients with an employment contract, compared to care as usual (CAU). In addition, we will investigate the effect of the…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For both the RCT and the cohort study the primary outcome is sustainable
employment expressed in the number of actual working hours.
Secondary outcome
RCT: actual working hours and contractual working hours, readiness for return
to work stage (assessed by the Readiness for Return to Work scale); work
ability (measured by the Work Ability Index); health-related work functioning
(measured by the Work Role Functioning Questionnaire); time to return to work
(measured as the number of calendar days between the first day of sick leave
and the first day of work, either fulltime or part-time, for at least 28
consecutive days without recurrence); and HRQoL (measured by the European
Organization for Research and Treatment of Cancer Quality of Life Questionnaire
- Core 30).
Cohort: Sick leave, health-related work functioning, caregiver burden,
depression, and HRQoL. Most of these measures correspond to the measures
included in the questionnaire for cancer patients in the RCT, with the
exception of caregiver burden (measured by the Caregiver Burden Scale).
Background summary
Each year, approximately 118,500 individuals are newly diagnosed with cancer in
the Netherlands, of whom about 40-50% are of working age at time of diagnosis.
While about 64% of the patients are eventually able to return to work (RTW),
many experience physical and/or psychosocial problems that affect the
continuation of their working lives. Intervention programs that have been
developed up until now lack scientific evidence regarding RTW, and supportive
programs for occupationally active patients who are dealing with long-term
consequences of diagnosis and treatment at the workplace are missing
completely. Further, it is expected that cancer diagnosis and/or the treatment
process may have negative health- and work-related consequences for partners of
cancer patients as well. Their problems and needs are currently highly
under-recognized.
Study objective
(1) To evaluate the (cost-)effectiveness of an individual rehabilitation
program on RTW and continuation of work in cancer patients with an employment
contract, compared to care as usual (CAU). In addition, we will investigate the
effect of the program on secondary outcomes, e.g., readiness for RTW and
health-related quality of life (HRQoL), and perform a process evaluation.
(2) To evaluate health- and work-related consequences of cancer (e.g., sick
leave, caregiver burden, HRQoL) in partners of patients. In addition, we will
gain insight in health- and work-related experiences and needs among partners
of patients, and develop a model to predict employment status in these
patients.
Study design
(1) A two-armed randomized controlled trial (one intervention group who
receives the intervention program, one control group who receives care as
usual, N=118 per group). Participants will be asked to fill in three
questionnaires, at baseline (T0), at six (T1), and 12 months (T2) follow-up
(45-60m).
(2) A longitudinal cohort study (N=267) of partners of cancer patients.
Participants will be asked to fill in three questionnaires, at baseline (T0),
at six (T1), and 12 months (T2) follow-up (30, 30 and 15 minutes).
Intervention
One introductory session (1.5h), a maximum of eight individual rehabilitation
sessions with an occupational therapist (1h each), potentially a telephone
consults (0.5h), and a maximum of two sessions with a re-integration consultant
and/or a relevant party from the workplace (1.5h). The minimum requirements
are: the introductory session (1.5h), at least one session with an occupational
therapist (1h), and the session with the re-integration consultant (1.5h).
The reintegration consultant is specialized in reintegration consultancy for
cancer survivors and can provide information about, for example:
-Efficient communication with an employer about cancer and reintegration
-How to effecitvely build up working hours for employees who have (had) cancer
-Relevant legislation and regulations for employees with cancer and their
employers
-The late / long-term effects of cancer (treatment) at work
Study burden and risks
The intervention consists of a maximum of nine sessions with a time investment
of maximum 11 hours (without travelling time, see E4). The patients in the
control group do not have to invest any additional time. Next to this, we will
ask participants (both intervention and control) to fill out questionnaires at
three times during the course of the study. Filling out these questionnaires
will take approximately 45-60 minutes per questionnaire. Questionnaires will be
offered online, unless this is a problem for the patient. In that case,
questionnaires will be offered in hard copy. The maximum estimated time that
patients will spend on our study will therefore be 14 hours (11 + 3, for the
intervention group) and 3 hours (for the control group).
Partners who will participate in our cohort will be asked to fill out
questionnaire at 3 occasions (30, 30 and 15 minutes). The estimated time that
partners will spend on our study will therefore be 1 hour and 15 minutes.
Apart from this time investment, there is no foreseeable extra burden or risk
associated with participating in this study.
van der Boechorststraat 7
Amsterdam 1081BT
NL
van der Boechorststraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
For the RCT on cancer patients: The sample will be composed of cancer survivors
of working age (18-64 years of age at time of diagnosis), with histologically
confirmed cancer and a life expectancy of more than one year. At study entry,
eligible cancer survivors have a fixed or temporary employment contract, with
at least six months left of their contract, and a history of paid work for at
least one year prior to diagnosis (with a minimum of 8 contracted working
hours/week). Cancer survivors can both be at work or (partly) on sick leave
when entering the study. Cancer survivors will be recruited 3-18 months
post-diagnosis. The cut-off for the maximum time post-diagnosis was set at 18
months in order to complete the intervention before a potential WIA assessment,
which takes place at 24 months of sick leave to determine whether someone will
receive work disability benefits (18 + 6 months intervention = 24 months).
Cancer survivors will be eligible for inclusion if they are, or have been,
treated with at least radiotherapy and/or chemotherapy. Prior research has
shown that cancer survivors who received complex treatments, i.e.,
chemotherapy, radiotherapy, or a combination thereof, indicated lower
workability than cancer survivors who were treated by means of surgery alone
[6]. Therefore, we conclude that cancer survivors who have received
chemotherapy and/or radiotherapy, alone or in combination with hormonal
therapy, immunotherapy, or surgery, could potentially benefit more from the
STEPS intervention than cancer survivors who were treated by means of hormonal
therapy, immunotherapy, or surgery alone. Patients should have a life
expectancy of more than 1 year.
For the partner cohort: Partners are defined as being married to or cohabiting
with a cancer survivors at the time of the cancer diagnosis and at study entry.
Eligible partners are between 18-65 years of age, had paid work (i.e., have a
fixed or a temporary employment contract, or are self-employed) at the time of
diagnosis of the cancer survivors, and have a history of paid work for at
least one year prior to diagnosis (i.e., a minimum of 8 working hours/week).
Partners of cancer survivors can be at work or (partly) on sick leave when
entering the study. Both partners of cancer survivors who accepted the
invitation to participate in the RCT and partners of those cancer survivors who
declined participation in the RCT will be eligible to participate. For the
cohort study, partners of patients who were diagnosed with cancer a maximum of
five years ago are eligible.
Exclusion criteria
For the RCT on cancer patients: Cancer survivors will be excluded if their
treating physicians consider occupational rehabilitation unfeasible, if cancer
survivors have serious cognitive or psychiatric problems, or serious physical
comorbidities that would preclude them from participating in an occupational
rehabilitation program, and/or if cancer survivors lack basic proficiency in
Dutch. cancer survivors participating in concurrent studies or rehabilitation
programs aimed at RTW or continuation of work prior to their potential
participation in the STEPS study will also be excluded. cancer survivors will
be asked about their participation in concurrent studies or rehabilitation
programs on the screening questionnaire and during the screening interview by
telephone. Furthermore, cancer survivors will be excluded if they are, or have
been, treated by means of surgery, immunotherapy, or anti-hormonal therapy
alone. Lastly, cancer survivors will be excluded if they refuse the involvement
of their employer in the STEPS intervention.
For the partner cohort: Partners will be excluded in case of serious
self-reported cognitive or psychiatric problems that would prevent them from
completing the questionnaires, and/or in case they are not able to understand
and complete a questionnaire in Dutch.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71870.029.19 |