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

2019 ◽  
Author(s):  
Katleen Van der Gucht ◽  
Soumaya Ahmadoun ◽  
Michelle Melis ◽  
Anneleen Gebruers ◽  
Ann Smeets ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Cognitive Impairment ◽  
Cancer Patients ◽  
Brain Connectivity ◽  
Controlled Trial ◽  
Breast Cancer Patients ◽  
Functional Brain ◽  
Randomized Controlled

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.

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

2020 ◽  
Author(s):  
Katleen Van der Gucht ◽  
Michelle Melis ◽  
Soumaya Ahmadoun ◽  
Anneleen Gebruers ◽  
Ann Smeets ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cognitive Impairment ◽  
Cancer Patients ◽  
Brain Connectivity ◽  
Controlled Trial ◽  
Breast Cancer Patients ◽  
Functional Brain ◽  
Randomized Controlled

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

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

2019 ◽  
Author(s):  
Katleen Van der Gucht ◽  
Soumaya Ahmadoun ◽  
Michelle Melis ◽  
Anneleen Gebruers ◽  
Ann Smeets ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cognitive Impairment ◽  
Cancer Patients ◽  
Brain Connectivity ◽  
Controlled Trial ◽  
Breast Cancer Patients ◽  
Functional Brain ◽  
Randomized Controlled

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

scholarly journals A Randomized Controlled Trial of the Effects of Transcendental Meditation on Quality of Life in Older Breast Cancer Patients

2009 ◽  
Vol 8 (3) ◽  
pp. 228-234 ◽  
Author(s):  
Sanford I. Nidich ◽  
Jeremy Z. Fields ◽  
Maxwell V. Rainforth ◽  
Rhoda Pomerantz ◽  
David Cella ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Transcendental Meditation ◽  
Controlled Trial ◽  
Breast Cancer Patients ◽  
Randomized Controlled

scholarly journals The Effects of Qigong Intervention Based On Internet On Quality of Life And Physical Fitness In Chinese Postoperative Breast Cancer Patients: A Protocol of Randomized Controlled Trial

2021 ◽  
Author(s):  
Lina Yu ◽  
xiaosheng Dong ◽  
kai Yuan ◽  
Xiangren Yi ◽  
Yuanlong Shen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Physical Fitness ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Breast Cancer Patients ◽  
Exercise Rehabilitation ◽  
Randomized Controlled

Abstract Background: The purpose of this study is to verify the improvement of remote qigong intervention on the quality of life and physical fitness of breast cancer patients after surgery by means of a randomized controlled trial, and to compare it with the conventional exercise combination of aerobic exercise and resistance training.Methods/design: The research approach applied in this study is a randomized controlled trial. After completing the baseline questionnaire and physical fitness test, participants were randomly assigned to either the qigong group or the combined exercise rehabilitation group. Patients in the qigong group performed Qigong-Baduanjin twice a week for 30 minutes each time under remote guidance and practiced Baduanjin by themselves at other times. Patients in the combined exercise rehabilitation group were given resistance training twice a week for 30 minutes under remote guidance, and walking the rest of the time. At the end of the 12-week intervention, outcomes testing and data collection were carried out. The primary outcomes are quality of life, measured using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), and the Functional Assessment of Cancer Therapy-Breast (FATC-B). The secondary outcomes include cardiopulmonary endurance, upper limb strength, lower limb strength and skinfold thickness.Discussion: The importance of postoperative exercise rehabilitation for breast cancer has been gradually accepted by more and more doctors and patients, but further research and development of simple and practical means of exercise rehabilitation are necessary. Remote qigong intervention for breast cancer patients via the Internet will be a great alternative.Trial registration: chictr, ChiCTR1900027989 December 7, 2,http://www.chictr.org.cn/index.aspx

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