Abstract
Background: Mindfulness has been applied to improve cancer care by enhancing psychological well-being. However, little is known about its impact on cognitive impairment experienced by cancer patients after chemotherapy. Mindfulness may be relevant in tackling cognitive impairment by decreasing emotional distress and fatigue, by decreasing inflammation, and by strengthening functional brain connectivity. The aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast cancer patients after chemotherapy.
Methods: The present study is a three-arm parallel-group randomized controlled trial with assessments at baseline, one to three weeks after the intervention and at three months follow-up. One hundred twenty breast cancer patients who ended treatment minimum 6 months and maximum 5 years before and who have cognitive complaints will be enrolled. They will be randomized into one of the following 3 study arms: (1) a mindfulness-based intervention group (n=40), (2) an active control condition based on physical training (n=40), or (3) a treatment as usual (TAU) control group (n=40). Both the mindfulness-based intervention and the active control condition exist of 4 group sessions (3 hours for the mindfulness condition and 2 hours for the physical training) spread over 8 weeks. The primary outcomes will be cognitive complaints as measured by the cognitive failure questionnaire and changes in functional brain connectivity in the attention network. Secondary outcomes will be (1) levels of emotional distress, fatigue, mindfulness, quality of life; (2) neurocognitive tests; (3) structural and functional brain changes using MR imaging, and (4) inflammation.
Discussion: The study will examine the impact of a mindfulness-based intervention on cognitive impairment in breast cancer patients. If the findings of this study confirm the effectiveness of a mindfulness-based program to reduce cognitive impairment, it will be possible to improve quality of life for ex-cancer patients. We will inform health care providers about the potential use of a mindfulness-based intervention as a non-pharmaceutical, low-threshold mental health intervention to improve cognitive impairment after cancer.
Trial Registration: ClinicalTrials.gov, NCT03736460. Retrospectively registered on 8th November 2018.
Keywords: Cognitive impairment, Breast cancer, Mindfulness, Randomized controlled trial, Brain imaging.
A mindfulness-based intervention for breast cancer patients with cognitive impairment after chemotherapy: study protocol of a three-group randomized controlled trial
