A mindfulness-based intervention for breast cancer patients with cognitive impairment after chemotherapy: study protocol of a three-group randomized controlled trial

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/design: The present study is a three-arm, parallel-group, randomized controlled trial with assessments at baseline, 1 to 3 weeks after the intervention and at 3 months' follow-up. One hundred and twenty breast cancer patients who ended treatment a minimum of 6 months and a maximum of 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 mindfulnessbased 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 consist of four group sessions (3 h for the mindfulness condition and 2 h for the physical training) spread over 8 weeks. The primary outcomes will be cognitive symptoms 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) measures of inflammation.

Cognitive Failures: Relationship with Perceived Emotions, Stress, and Resting Vagally-Mediated Heart Rate Variability

“…The potential negative consequences of cognitive failures, which go from potentially rather harmless daily small distractions to more serious consequences with accidents [47][48][49], triggered the interest of researchers to develop interventions to face cognitive failures. Those interventions considered different time scales, and were realized either on an acute basis manipulating the perceptual load [50], or on a more chronic basic, with long-term interventions based on mindfulness [51] or targeting stress management [52].…”

Tumour brain: Pretreatment cognitive and affective disorders caused by peripheral cancers

“…These findings indicate that central VTA stimulation, and thus enhanced levels of reward and motivation in mice, can modulate the immune system via SNS‐mediated suppression of MDSCs (Ben‐Shaanan et al, 2018). This emphasises the important translational implications of these rodent studies and suggests that those people who keep active, remain motivated and receive enough emotional support and VTA reward system activation after a cancer diagnosis may show reduced tumour growth/aggressiveness or better responses to chemotherapy treatments (Mehta et al, 2019; Van der Gucht et al, 2020).…”

Effect of Wearable Technology-Based Physical Activity Interventions on Breast Cancer Survivors’ Physiological, Cognitive, and Emotional Outcomes: A Systematic Review

“…Major risk factors associated with breast cancer in the physiological domain include sedentary lifestyles and associated chronic diseases such as obesity, hypertension, diabetes, and cardiovascular disease, to list a few [4]. Additionally, research indicates that approximately 78% of BCS also experience acute or chronic negative effects on cognitive function with many survivors reporting fogginess, loss of memory, attention deficit, and slowed cognitive function, among other perceived cognitive effects [5,6]. Lastly, breast cancer often has profound effects on survivors' mental health and emotional wellbeing as depression, anxiety, fatigue, and stress are often observed at high levels in this population [6,7].…”

“…Additionally, research indicates that approximately 78% of BCS also experience acute or chronic negative effects on cognitive function with many survivors reporting fogginess, loss of memory, attention deficit, and slowed cognitive function, among other perceived cognitive effects [5,6]. Lastly, breast cancer often has profound effects on survivors' mental health and emotional wellbeing as depression, anxiety, fatigue, and stress are often observed at high levels in this population [6,7]. These three factors can individually or collectively influence a BCS' HRQoL which can lead to a worsening of their overall health and create unnecessary risk for new or recurring diseases to develop.…”

“…Indeed, only 16% of BCS met the physical activity recommendations set by the U.S. Department of Health and Human Services of ≥150 min of moderate-intensity physical activity or ≥75 min of vigorous-intensity physical activity per week [9,10]. Additionally, this population also exhibits age-related risks, a higher prevalence of obesity, and many of the cognitive and emotional struggles previously outlined [5,6,8]. Thus, identifying innovative and effective physical activity promotion intervention strategies among BCS is an emerging public health challenge.…”