Cognitive Impairment Clinical Trial
Official title:
A Mindfulness-based Intervention for Breast-cancer Patients With Cognitive Impairment After Chemotherapy: Study Protocol of a Three-Group Randomized Controlled Trial
Background: Mindfulness has been applied to improve after 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 brain functional 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-group randomized controlled trial with assessments at
baseline, one-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 three study arms: (1) a mindfulness-based intervention group (n=40), (2) an active
control condition based on physical training (n=40), or (3) a waitlist control group (n=40).
Both the mindfulness-based intervention and the active control condition exist of four 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 brain functional connectivity in the attention network.
Secondary outcomes will be (1) levels of emotional distress, fatigue, mindfulness; (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.
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