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A return-to-work intervention protocol directed at cancer patients (self-assessment, tailored information & lifestyle management for returning to work among cancer patients, START): A multi-center, randomized controlled trial.

ABSTRACT: Purpose:This study describes the protocol for the design and evaluation of a self-assessment based educational program supporting cancer patients' return-to-work (RTW), prior to its complete and ongoing implementation. Methods:We designed a multi-center, randomized controlled trial with three follow-up points. The study population (N = 239) includes recently diagnosed cancer patients who plan to receive active treatment at two university hospitals in Korea. A pre-test is conducted at the point of enrollment for both groups. The intervention group receives a leaflet clarifying misconceptions about RTW and is shown a video clip of patient interviews concerning RTW. The control group receives a booklet about cancer and nutrition, and is not provided with further intervention. After active treatment, the intervention group receives a one-time, face-to-face education session with an oncology nurse. Following the education session, both groups receive three follow-up phone calls. The first follow-up call occurs at the end of intervention and at the end of active treatment for intervention and control groups, respectively. The next two follow-up calls will be conducted one month and a year following the post-test. The primary outcome is whether the patient has RTW or has plans to RTW, and the secondary outcome is knowledge of RTW. Results:As of April 2020, 239 patients have been enrolled in the trial. Statistical analyses will be conducted upon trial completion in December 2020. Discussion:We hypothesize that the provision of RTW education near diagnosis will not only enhance patients' intentions to RTW, but also effectively encourage them to RTW.

SUBMITTER: Bae KR

PROVIDER: S-EPMC7451719 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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A return-to-work intervention protocol directed at cancer patients (self-assessment, tailored information & lifestyle management for returning to work among cancer patients, START): A multi-center, randomized controlled trial.

Bae Ka Ryeong KR Kang Danbee D Yi Jae Yoon JY Ahn Yeojin Y Kim Im-Ryung IR Kweon Sun-Seog SS Ahn Jin Seok JS Nam Seok Jin SJ Shim Young Mog YM Chun Mison M Heo Jaesung J Cho Juhee J

Contemporary clinical trials communications 20200812

<h4>Purpose</h4>This study describes the protocol for the design and evaluation of a self-assessment based educational program supporting cancer patients' return-to-work (RTW), prior to its complete and ongoing implementation.<h4>Methods</h4>We designed a multi-center, randomized controlled trial with three follow-up points. The study population (N = 239) includes recently diagnosed cancer patients who plan to receive active treatment at two university hospitals in Korea. A pre-test is conducted ...[more]

PMID: 32885089

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Project description:Background and study aims An increasing number of cancer survivors are of working age. Cancer is also a known cause of people withdrawing early from the labour market and also a prolonged absence from work due to sickness. Cancer survivors in lower socioeconomic groups (for example, people who do lower skilled jobs) and/or suffer from another disease (co-morbidity) are at particular risk of recurrent sickness absence, unemployment or permanent withdrawal from the labour market. Not being able to work to the same ability and unfavourable work conditions can also mean that cancer survivors of lower socioeconomic status and/or co-morbidity find returning to work more difficult. Support from supervisors and adjustments that make it possible for the cancer survivor to do their job more easily (work accommodations) may be important in preventing sickness relapses due to the job environment affecting their state of health. It is not known how important occupational rehabilitation during cancer treatment might be in helping cancer survivors return to work and, in particular, how it may help those patients of lower socioeconomic status and/or co-morbidity. This study aims to increase the likelihood of cancer survivors returning to work through a programme (intervention) of individual support offered by a job consultant connected to the oncology ward at Aarhus University Hospital. Who can participate? Cancer patients between 18 and 60 years of age who are living in Randers or Silkeborg municipalities in Denmark diagnosed with breast, gastro-intestinal, head and neck, testis, ovarian or cervix cancer and being treated with chemotherapy or radiotherapy. They must be permanently or temporary employed (with at least 6 months left of their contract) and possibly on sick leave. What does the study involve? Patients that meet the criteria for participating in the trial and living in either Randers or Silkeborg municipalities in Denmark are placed in the intervention group. Patients that meet the criteria but live outside of these municipalities are placed in the control group. Those in the intervention group take part in an early, tailored return to work management programme that supports cancer patients as they are undergoing treatment. Those in the control group are offered the standard sick leave management programme. The return to work rates among cancer survivors in the intervention group is then compared to those in the control group. The effect of the intervention on cancer survivors of lower socioeconomic status and/or co-morbidity is also assessed.

Project description:BackgroundA high percentage of patients with cancer experience cognitive impairment after cancer treatment, resulting in a decreased health-related quality of life and difficulty returning to work. Consequently, there is a need for effective treatment options to improve cognitive functioning in these patients. In a healthy aging population, multidomain web-based lifestyle interventions have been found to be effective in preventing cognitive decline and improving cognitive functioning.ObjectiveThis study aims to investigate the feasibility and effectiveness of the web-based lifestyle intervention Mijn Fitte Brein (My Fit Brain [MFB]) on cognitive functioning in patients with cancer returning to work.MethodsThe study consists of a feasibility study (N=10), followed by a randomized controlled trial (RCT; N=220). Patients will be recruited by their occupational physicians after their return to work following cancer treatment. Mijn Fitte Brein is organized into 4-week cycles in which patients set a lifestyle goal using the Goal Attainment Scale, receive weekly tips and support, and finally evaluate whether they succeeded in achieving this goal. Lifestyle goals are based on 6 domains: physical exercise, diet, sleep, stress, alcohol use, and smoking. In the feasibility study, data on user experience (structured interview) and usability, assessed with the Post-Study System Usability Scale, will be collected and used to optimize Mijn Fitte Brein. In the RCT, patients will be randomized 1:1 between an intervention group and a control group. Patients will be assessed at baseline, 3 months, and 6 months. The primary outcome measure is subjective cognitive functioning, assessed with the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog). Secondary outcome measures are lifestyle, objective cognitive functioning, and work and psychosocial factors.ResultsRecruitment for the feasibility study has started in February 2020. As of July 2020, however, no patients have been enrolled (due to COVID-19 restrictions). The findings of the feasibility study will be used to optimize the Mijn Fitte Brein intervention. Enrollment for the RCT will continue when possible. The feasibility study will take 6 months (including making adjustments to the intervention), and the RCT will take 2 years. The final results are expected in 2024. The results of the feasibility study and the RCT will be published in peer-reviewed journals.ConclusionsThis is the first time the feasibility and efficacy of a multidomain web-based lifestyle intervention will be studied in patients with cancer. If Mijn Fitte Brein is found to be effective in decreasing cognitive complaints in these patients returning to work, it will be a promising treatment option because of being both affordable and accessible.Trial registrationNetherlands Trial Register NL8407; https://www.trialregister.nl/trial/8407.International registered report identifier (irrid)DERR1-10.2196/22670.

Dataset Information

A return-to-work intervention protocol directed at cancer patients (self-assessment, tailored information & lifestyle management for returning to work among cancer patients, START): A multi-center, randomized controlled trial.

Publications

A return-to-work intervention protocol directed at cancer patients (self-assessment, tailored information & lifestyle management for returning to work among cancer patients, START): A multi-center, randomized controlled trial.

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