Re-Employment for Cancer Patients and survivors.|
|- candidate number||13209|
|- NTR Number||NTR3562|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-aug-2012|
|- Secondary IDs||WC 2011-044 METC VUmc|
|- Public Title||Re-Employment for Cancer Patients and survivors.|
|- Scientific Title||The effectiveness of a tailored intervention program on return-to-work in unemployed sick-listed cancer patients and survivors: A randomized controlled trial.|
|- hypothesis||Unemployed cancer patients and survivors face severe challenges regarding return-to-work compared to employed cancer patients and survivors. To accommodate for their specific needs regarding return-to-work, a tailored intervention program was designed, which specifically aims to enhance return-to-work in unemployed cancer patients and survivors. The (cost-) effectiveness of this program will be tested in a randomized controlled trial. We hypothesize that persons in the intervention group of the trial will demonstrate earlier and sustainable return-to-work, compared to the persons in the control group.|
|- Healt Condition(s) or Problem(s) studied||Cancer, Cancer survivors, Return to work, Tailored intervention program|
|- Inclusion criteria||Patients and survivors are eligible to participate in this study, when they are between 18 and 60 years old, when they have a primary diagnosis of cancer and when this diagnosis is registered at UWV, as the main cause for their sick-leave. Furthermore, they must be registered at UWV as a social security safety netter without an employment contract; they must have applied for a sickness benefit and they must be at sick leave for at least 3 months up to 18 months. Patients will be included if they are receiving treatment with curative intent, defined as a 1 year survival rate of ca. 80% at time of diagnosis. In case a patient is still undergoing intensive cancer treatment (chemotherapy, radiotherapy, surgery or a combination of those), he/she will be included at a minimum of 6 weeks after finishing these treatments.|
|- Exclusion criteria||Patients will be excluded in case of comorbidity of such kind that participating in the tailored intervention program is not possible (assessment by an insurance physician), in case of serious psychiatric disorders, in case of pregnancy, in case of a lack of knowledge of the Dutch language and/or in case of a conflict with UWV regarding a (previous) sickness benefit claim or a long-term disability claim. Additionally, patients will be excluded if they are participating or signed up to be participating in a concurrent scientific study and/or re-integration/rehabilitation program.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2012|
|- planned closingdate||1-nov-2015|
|- Target number of participants||164|
|- Interventions||The tailored intervention program starts with an introductory interview, during which the tailored intervention program will be explained and obstacles for return-to-work and other forms of activities will be identified. This will also include an assessment of the participants’ cognition regarding return-to-work, needs for additional therapy (e.g., physical and/or psycho-educational), and the skills and knowledge of the participant regarding work and job application processes (e.g., the skill to write letters of application). At the end of this meeting, a personalized intervention plan will be composed. The plan will consist of three main components:|
1. Coaching: A maximum of 8 sessions during which cancer-related and return-to-work-related problems are addressed (e.g., fatigue);
2. Recovery: Stress reducing group therapy using the Heartmath method. Optionally, mental and/or physical components are offered through professional primary and secondary care;
3. Job application: Maximum of 8 sessions during which rehabilitation skills, job application skills are improved and a work profile and a “route to work” are created. When the first part of the intervention is finished, the participant has a conclusive meeting during which his/her own “action to work-plan” is completed, which consists of several components (i.e., curriculum vitae. Next, the participant will be assigned to a job coach at an independent job hunting agency. The job coach will take into account the work(place)profile that was created by the reintegration agency, to determine the suitable type of work, work content, and necessary preconditions for work resumption. To create an actual return-to-work perspective, the participant will be offered the possibility of placement in a temporary (therapeutic) workplace or paid employment for a period of three months minimum.
The control group will receive usual care.
|- Primary outcome||The primary outcome measure of this study is duration until sustainable return-to-work after sick leave, calculated as the number of days between the first date of sick leave and the first day the participant returns to work. Sustainable return-to-work is defined as the duration of sick leave due to cancer diagnosis in calendar days from the day of randomization until return-to-work, for at least 4 weeks without recurrence.|
|- Secondary outcome||Rate of return-to-work during follow-up, readiness to return to work, fatigue, psychological distress, general participation in society, coping, general health and health related quality of life.
Other parameters are: socio-demographic factors, co-morbidity, questions regarding cancer diagnosis and treatment, work-related questions.|
|- Timepoints||Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3).|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Han J.R. Anema|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Han J.R. Anema|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|UWV (Workers Insurance Authority)|
|- Brief summary||As unemployed cancer patients and survivors experience severe challenges regarding return-to-work when compared to employed patients and survivors, it is considered worthwhile to study the effects of a return-to-work intervention program, tailored to the specific needs regarding return-to-work for this group.
To evaluate the effectiveness of a tailored intervention program for unemployed sick-listed cancer patients and survivors on return-to-work, compared to care as usual.
This study will employ a two-armed RCT with a follow-up period of 12 months.
“Study population: Unemployed workers who have been sick-listed due to cancer for 12-36 months
and who have applied for sickness or disability benefits at SSA.”
The participants the intervention group of this study receive a tailored intervention program coordinated by a specialized re-integration agency, including a placement at work, coordinated by a job hunting coach. The intervention will target physical, mental, and rehabilitation problems. The program consists of general components (e.g., coaching) and specialist components (e.g., physical therapy) if necessary. The combination of these components will differ per participant and will be adjusted to the individual needs, capabilities and personal situation of the participant. The program will be offered on a national level in the Netherlands.
Main study parameters/endpoints:
The primary outcome measure of this study is duration until sustainable RTW after sick
leave, calculated as the number of days between the day of randomisation and the first day of
sustainable RTW. Sustainable RTW is defined as a period of minimum 28 calendar days,
during which the cancer survivor is working according to schedule. Work can be either paid
work or work resumption with ongoing benefits, e.g., work with therapeutic conditions.
|- Main changes (audit trail)||21-dec-2014: Changes due to amendments: |
- Changed inclusion criterium: "They must have applied for sickness or disability benefits and
must be on sick leave for at least 12 months up to 36 months. Patients will be included if their
health status allows them to participate in the study (based on self-report by the cancer
survivor) and if they have no comorbidities (e.g., severe psychological or physical conditions)
that would interfere with participating in this study (based on report from the cancer survivor’s
general practitioner (GP))."
- Changed exclusion criterium: "(assessment by
the participants’ general physician)"
- Changed intervention: "Recovery: Optionally, mental and/or physical components
are offered through professional primary and secondary care."
- Changed primary outcome: "The primary outcome measure of this study is duration until sustainable RTW after sick leave, calculated as the number of days between the day of randomisation and the first day of sustainable RTW. Sustainable RTW is defined as a period of minimum 28 calendar days, during which the cancer survivors is
working according to schedule. Work can be either paid work or work resumption with
ongoing benefits, e.g., work with therapeutic conditions."
- Updated summary - AB
|- RECORD||7-aug-2012 - 21-dec-2014|
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