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Sustained employability in cancer patients and their partners (STEPS)

Sustained employability in cancer patients and their partners (STEPS) - STEPS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52691
Enrollment
503
Registered
2020-10-30
Start date
2021-09-22
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer neoplasm

Interventions

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 session

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
For both the RCT and the cohort study the primary outcome is sustainable employment expressed in the number of actual working hours.

Secondary

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)