scholarly journals Supporting participation in paid work of cancer survivors and their partners in the Netherlands: protocol of the SusTained Employability in cancer Patients and their partnerS (STEPS) multi-centre randomized controlled trial and cohort study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Amber D. Zegers ◽  
Pieter Coenen ◽  
Ute Bültmann ◽  
Valesca Retèl ◽  
Jacobien M. Kieffer ◽  
...  
Keyword(s):  
Cohort Study ◽  
Cancer Survivors ◽  
Usual Care ◽  
Controlled Trial ◽  
Working Hours ◽  
Rehabilitation Program ◽  
Work Retention ◽  
Work Related ◽  
Health Related ◽  
Work And Health

Abstract Background Many cancer survivors experience physical and/or psychosocial problems affecting return to work (RTW) and work retention. Current interventions on RTW lack evidence regarding effectiveness, while interventions for work retention are missing. Partners of cancer survivors may also experience work- and health-related outcomes; yet, these consequences are not well understood. Here, the protocol of the STEPS study is described. The study aims are to: 1) evaluate the (cost-)effectiveness of a rehabilitation program for RTW and work retention in cancer survivors, and 2) assess health- and work-related outcomes among cancer survivors’ partners. Methods In a multicentre Randomized Controlled Trial (RCT), 236 working-age cancer survivors with an employment contract will be randomly allocated to a usual care group or an intervention group receiving a multidisciplinary rehabilitation program, combining occupational therapy facilitating work retention (e.g., energy management and self-efficacy training) and reintegration consultation addressing work-related issues (e.g., RTW planning and discussing workplace or task modifications with the supervisor). Alongside the RCT, a prospective cohort study will be conducted among cancer survivors’ partners (n = 267). Participants in the RCT and cohort study will be asked to complete questionnaires at baseline, and after six and 12 months, assessing work- and health-related outcomes. Generalized estimating equations will be used to assess intervention’s effectiveness, compared to usual care, regarding primary (i.e., working hours per week) and secondary outcomes. Also economic and process evaluations will be performed. For the cohort study, logistic or linear regression modelling will be applied assessing work- and health-related outcomes (primary outcome: working hours) of cancer survivors’ partners, and what factors predict these outcomes. Results The study is planned to start in September 2021; results are expected in 2023. Conclusion Compared to usual care, the STEPS intervention is hypothesized to be (cost-)effective and the intervention could be a valuable addition to standard care helping cancer survivors to sustain employment. Further, it is expected that living with a cancer survivor has a substantial impact on work and health of partners, while specific groups of partners that are at particular risk for this impact are likely to be identified. Trial registration Dutch Trial Register (NTR;NL9094; 15-12-2020).

scholarly journals Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial.

2020 ◽  
Author(s):  
Kete Klaver ◽  
Saskia Duijts ◽  
Chantal Geusgens ◽  
Maureen Aarts ◽  
Rudolf Ponds ◽  
...  
Keyword(s):  
Cancer Survivors ◽  
Cognitive Rehabilitation ◽  
Work Performance ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Work Related ◽  
Randomized Controlled ◽  
Fatigue Management ◽  
Cognitive Problems ◽  
Active Cancer

Abstract Background Cognitive problems are common in non-central nervous system cancer survivors. These problems are perceived as an important contributor to decline in work performance and work ability. Various interventions for cognitive problems have been proposed, but effectiveness regarding work-related outcomes has not yet been established. Effective treatment options to alleviate the adverse influence of cognitive problems on work performance are needed for working cancer survivors. In this paper, we will describe the design of a randomized, controlled, multicenter trial that evaluates the (cost-)effectiveness of an internet-based cognitive rehabilitation program for occupationally active cancer survivors confronted with cognitive problems. Methods/ Design A three-armed randomized controlled trial will be conducted, including two intervention groups (i.e., basic and extensive cognitive rehabilitation program) and one waitlist control group. In total, 261 cancer survivors (18 – 65 years) who have returned to work, and who experience cognitive problems will be recruited. Patients with and without cognitive impairment as established in a neuropsychological assessment, will be eligible; stratification will take place based on the presence of this cognitive impairment. The extensive intervention arm will contain a comprehensive training program (including psycho-education, fatigue management, and cognitive strategy training) with individual guidance (blended intervention). The basic intervention arm will contain a brief cognitive training program (including psycho-education and fatigue management) without individual guidance. The primary outcome will be accomplishment of an individually defined work-related treatment goal. Secondary outcomes include, among others, subjective cognitive functioning, work functioning, and quality of life. Primary and secondary outcomes will be measured at baseline (T0), and at 12 weeks (T1) and 26 weeks (T2) post-randomization. Discussion About 40-50% of the cancer patients worldwide are of working age at time of diagnosis. Many of the occupationally active cancer survivors experience cognitive problems. Both from an individual and a societal perspective, it is important to sustain cancer survivors’ employability. An effective treatment to alleviate the impact of cognitive decline and to improve work ability might help cancer survivors to sustain employability.Trial registration The trial is registered at ClinicalTrials.gov (NCT03900806) at 03 April 2019 (current status: ongoing),https://clinicaltrials.gov/ct2/show/NCT03900806?term=NCT03900806&draw=2&rank=1.

scholarly journals Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial

2020 ◽  
Author(s):  
Kete Klaver ◽  
Saskia Duijts ◽  
Chantal Geusgens ◽  
Maureen Aarts ◽  
Rudolf Ponds ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Impairment ◽  
Cancer Survivors ◽  
Cognitive Rehabilitation ◽  
Work Performance ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Work Related ◽  
Randomized Controlled ◽  
Cognitive Problems

Abstract Background Cognitive problems are common in non-central nervous system cancer survivors. These problems are perceived as an important contributor to decline in work performance and work ability. Various interventions for cognitive problems have been proposed, but effectiveness regarding work-related outcomes has not yet been established. Effective treatment options to alleviate the adverse influence of cognitive problems on work performance are needed for working cancer survivors. In this paper, we will describe the design of a randomized, controlled, multicenter trial that evaluates the (cost-)effectiveness of an internet-based cognitive rehabilitation program for occupationally active cancer survivors confronted with cognitive problems. Methods/ Design A three-armed randomized controlled trial will be conducted, including two intervention groups (i.e., basic and extensive cognitive rehabilitation program) and one waitlist control group. In total, 261 cancer survivors (18 – 65 years) who have returned to work, and who experience cognitive problems will be recruited. Patients with and without cognitive impairment as established in a neuropsychological assessment, will be eligible; stratification will take place based on the presence of this cognitive impairment. The extensive intervention arm will contain a comprehensive training program (including psycho-education, fatigue management, and cognitive strategy training) with individual guidance (blended intervention). The basic intervention arm will contain a brief cognitive training program (including psycho-education and fatigue management) without individual guidance. The primary outcome will be accomplishment of an individually defined work-related treatment goal. Secondary outcomes include, among others, subjective cognitive functioning, work functioning, and quality of life. Primary and secondary outcomes will be measured at baseline (T0), and at 12 weeks (T1) and 26 weeks (T2) post-randomization. Discussion About 40-50% of the cancer patients worldwide are of working age at time of diagnosis. Many of the occupationally active cancer survivors experience cognitive problems. Both from an individual and a societal perspective, it is important to sustain cancer survivors’ employability. An effective treatment to alleviate the impact of cognitive decline and to improve work ability might help cancer survivors to sustain employability. Trial registration The trial is registered at ClinicalTrials.gov (NCT03900806) at 03 April 2019 (current status: ongoing),https://clinicaltrials.gov/ct2/show/NCT03900806?term=NCT03900806&draw=2&rank=1. KEYWORDS Cancer-related cognitive impairment, Cognitive rehabilitation, Employment, Internet-based, Randomized controlled trial, Cost-effectiveness

Impact of symptom burden on health related quality of life of cancer survivors in a Danish cancer rehabilitation program: A longitudinal study

2010 ◽  
Vol 50 (2) ◽  
pp. 223-232 ◽  
Author(s):  
Trille Kristina Kjaer ◽  
Christoffer Johansen ◽  
Else Ibfelt ◽  
Jane Christensen ◽  
Nina Rottmann ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Longitudinal Study ◽  
Cancer Survivors ◽  
Symptom Burden ◽  
Rehabilitation Program ◽  
Cancer Rehabilitation ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

scholarly journals Wool-derived keratin dressings versus usual care dressings for treatment of slow-healing venous leg ulceration: study protocol for a randomised controlled trial (Keratin4VLU)

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e020319 ◽  
Author(s):  
Andrew Jull ◽  
Angela Wadham ◽  
Chris Bullen ◽  
Varsha Parag ◽  
Jill Waters
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionKeratins, filament-forming proteins found in vertebrate epithelium, are downregulated in slow-healing venous leg ulcers (VLU) compared with normal-healing VLU. Laboratory and animal model research has suggested exogenous keratins increase expression of endogenous keratins. A non-randomised controlled trial of an exogenous keratin dressing reported increased healing in slow-healing VLU. To date, no randomised controlled trial has been done to verify these promising findings.Methods and analysisThe Keratin4VLU trial is a single-blind, pragmatic, parallel group, randomised controlled trial of keratin dressings compared with usual care non-medicated dressings in patients with VLU where either (1) the ulcer area is greater than 5 cm2, (2) the ulcer has been present for more than 26 weeks or (3) both. All patients will receive compression therapy. The primary outcome is the proportion of patients with healed VLU at 24 weeks after randomisation as adjudicated by blinded review of an ulcer photograph. Secondary outcomes are time to healing, estimated change in ulcer area, change in health-related quality of life, agreement between blinded and unblinded assessors and adverse events. The analysis will be intention-to-treat on the primary and secondary outcomes (excepting health-related quality of life).Ethics and disseminationThe Keratin4VLU trial received ethical approval from the Northern A Health and Disability Ethics Committee. We plan to publish the results within 1 year of trial completion and will include the results on the trial registration page.Trial registration numberNCT02896725; Pre-results.

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