Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 20, 2020
Date Accepted: Feb 16, 2021
A web-based lifestyle intervention aimed at improving cognition in cancer patients returning to work in an outpatient setting: protocol of a randomized controlled trial
ABSTRACT
Background:
A high percentage of cancer patients experiences 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, multi-domain web-based lifestyle interventions have been found effective in preventing cognitive decline and improving cognitive functioning.
Objective:
This 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 cancer patients returning to work.
Methods:
The 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 after cancer treatment. MFB is organized in 4-week cycles in which patients set a lifestyle goal using goal attainment scaling, 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 System Usability Scale, will be collected and used to optimize MFB. In the RCT, patients will be randomized 1:1 between an intervention group and 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, work- and psychosocial factors.
Results:
Recruitment for the feasibility study has started in February 2020.
Conclusions:
This is the first time the feasibility and efficacy of a multi-domain web-based lifestyle intervention will be studied in cancer patients. If MFB is found to be effective in decreasing cognitive complaints in cancer patients returning to work, it will be a promising treatment option due to being both affordable and accessible. Clinical Trial: Netherlands Trial Register NL8407; https://www.trialregister.nl/trial/8407
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