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SusTained Employability in cancer Patients and their partnerS

SusTained Employability in cancer Patients and their partnerS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25514
Enrollment
503
Registered
2020-01-13
Start date
2021-08-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Cancer

Interventions

STEPS is a multidisciplinary intervention based on the Stages of Change, and combines work-related occupational therapy and reintegration consultation, to support cancer survivors in their RTW and wor

Sponsors

This research is initiated by Amsterdam UMC, location VUmc and is funded by the Dutch Cancer Society (ref. 11558 / 2018-01)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The sample will be composed of cancer survivors of working age (18-63 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 work disability assessment, which (in the Netherlands) takes place at 24 months of sick leave to determine whether someone will receive work disability benefits (18 + 6 months intervention = 24 months). Moreover, cancer survivors will be eligible for participation if they are, or have been, treated with at least radiotherapy and/or chemotherapy. Cancer survivors with additional treatment modalities, besides radiotherapy and/or chemotherapy, will be eligible for participation as well. Partners of a cancer survivor who participates in the intervention study are eligible. However, both partners of cancer survivors who do and do not participate in the intervention study will be eligible to participate in the cohort study. Partners of cancer survivors who have had a cancer diagnosis no more than 24 months ago and who have a life expectancy of at least one year, are eligible. Partners should be registered at the same address as the cancer survivor at least one year pre-diagnosis. Moreover, eligible partners should be between 18-65 years of age, have a fixed or a temporary employment contract at the time of diagnosis of the cancer survivors, and a history of paid work for at least one year prior to diagnosis (with =8 contracted working hours per week). Partners of cancer survivors can both be at work or (partly) on sick leave when entering the study.

Exclusion criteria

Exclusion criteria: Cancer survivors will be excluded if their treating physicians consider occupational rehabilitation not feasible, 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 return to work or work retention will also be excluded. Partners will be excluded from participation in the cohort study in case of self-reported serious cognitive or psychiatric problems that would prevent them from completing the questionnaires, and/or in case they are unable to understand and complete questionnaires in Dutch.

Design outcomes

Primary

MeasureTime frame
For both cancer survivors and partners of cancer survivors, the primary outcome ‘working hours’ is operationalized as the number of actual working hours at measurement point. For partners of cancer survivors we will additionally measure health-related quality of life. Health-related quality of life will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC QLQ C-30)). This 30-item list consists of five multi-item functional scales (i.e., physical, role, emotional, cognitive, and social), three multi-item symptom scales )i.e., fatigue, pain, and nausea and vomiting), six single-item (i.e., dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial impact), and a two-item global health and quality of life scale, all with a scoring range from 0 to 100. A higher score on the functional and global health and quality of life scales indicates better health-related quality of life, while on the symptom scales, a higher score indicates a higher level of symptom burden. A summary score will be generated, calculated as the mean of all combined scale scores, excluding financial impact and the global health and quality of life scale.

Secondary

MeasureTime frame
Secondary outcome measures are: For both cancer survivors and partners of cancer survivors •Change in working hours (in %): we will divide actual working hours at follow-up by contractual working hours at baseline, times one hundred. •Employment status: Asking participants whether they are at work or not at work. •Sick leave: Asking participants about the number of days they have been on sick leave in the past six months •Health-related work functioning will be measured using the 27-item Work Role Functioning Questionnaire [10], distinguishing five different work domains: work scheduling demands, mental demands, social demands, physical demands, and output demands (range 0 to 100). Higher scores indicate better work functioning. This questionnaire will only be completed by those who (partly) returned to work. Only for cancer survivors •Health-related quality of life: see above how this will be measured. •Readiness for Return-to-Work (RRTW) will be assessed using the translated and adapted, Dutch version of the original RRTW questionnaire. The systematic translation is currently being performed by our research team; •Work ability will be assessed using a single question of the Work Ability Index, asking participants to estimate their current work ability compared with their lifetime best (0, cannot work at all, to 10, best ever); •Time to return to work will be 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 (only for those who are on sick leave); Only for partners of cancer survivors •Caregiver burden: Using the ‘Ervaren Druk door Informele Zorg-plus’ (EDIZ) [55], consisting of 15 items, ranging from 0 to 1, higher scores indicate a higher caregiver burden •Depression: using the Centre for Epidemiological Studies Depression Scale; [56], consisting of 20 items and a range of 0 to 60, a score of 16 and over indicates the possibl

Contacts

Public ContactPieter Coenen

Amsterdam UMC, location VUmc - Department of Public and Occupational Health

p.coenen@amsterdamumc.nl+31204448381

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)