- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03817489
Mindfulness Meditation and Qigong for Colorectal Cancer Survivors
Starting From the Mind or the Body in Mind-Body Intervention: A Randomized Controlled Trial on Comparative Effectiveness of Mindfulness Meditation and Qigong on Psychophysiological Outcomes in Colorectal Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer is one of the most common forms of cancer. Lifestyle modification and development of self-regulatory and self-care skills for maintaining psychological and physical well-being are especially important for recurrence prevention and long-term illness management. Mind-body practices are popular among cancer patients for being non-pharmacological, holistically beneficial, in addition to its feasibility for sustainable self-practice and self-care. Despite the popularity of practising qigong and mindfulness meditation among local patients, a systematic study on their effectiveness for cancer patients has yet to be conducted.
Qigong and mindfulness meditation represent two distinct forms of mind-body practices: dynamic and static. With both approaches attending to the breath, Qigong relies on physical exertion to arrive at mental and psychological changes while mindfulness meditation begins at mental level but can also impact physical health. Yet current knowledge on mind-body practices tells little about these contrasting approaches. Hence, this study not only aims to provide evidence for the psychophysiological effectiveness of qigong and mindfulness meditation for colorectal cancer patients, but also elucidate how these two fundamentally contrasting approaches differ in psychophysiological outcomes, rebalancing of dysfunctional cortisol rhythm, and affect long-term practice compliance.
Adopting a 3-arm randomized controlled trial design, this study will first independently study the effectiveness of Baduanjin qigong and Mindfulness meditation for Chinese colorectal cancer patients compared to controls on cancer-related symptoms and symptom distress, mental health, quality of life, biomarkers and mindfulness level. Another main objective is to examine the commonalities and differential effectiveness between a movement-based (Baduanjin qigong) and a mind-based (Mindfulness meditation) practice on the above outcomes, magnitude and pace of change, and the extended compliance throughout the 8-month study. A final objective is to examine the relationships among physical, psychological, and psychophysical variables and how these interactions between the mind and body. This study envisions advancing relationships change across the time.
189 Chinese-speaking patients with colorectal cancer will be recruited from local hospital and community organizations, then randomized into an 8-week (90-min/week) (i) Baduanjin qigong intervention, (ii) Mindfulness meditation intervention and (iii) No-intervention waitlist control. Participants will be assessed on 4 time points at (i) baseline prior randomization, (ii) mid-intervention (4th week), (iii) post-intervention (8th week) and (iv) 6 months post-intervention.
The measurement of both physiological and psychological outcomes will offer a comprehensive understanding on the mental and bodily changes after each intervention and their maintenance. Results will further support the reciprocal evidence-based mind-body practices which can be easily learned, self-practiced and incorporated into patients' lifestyles.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rainbow Tin Hung Ho
- Phone Number: (852) 28315158
- Email: tinho@hku.hk
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- Centre on Behavioral Health, The University of Hong Kong
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Contact:
- Adrian Ho Yin Wan
- Phone Number: (852) 28315158
- Email: awan@hku.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of primary colorectal cancer of any stages 0 to III
- An expected survival length of 12 months or longer
- 0.5 to 5 years following completion of main treatment for colorectal cancer
- Ages 18 or higher
- Chinese speaking
Exclusion Criteria:
- Regularly practicing baduanjin qigong, other forms of qigong, taichi, meditation, mindfulness practices or yoga once a week or more
- Having participated in the above trainings in the past 6 months
- Severe cachexia, dizziness, bone pain, nausea or significant orthopedic problem or other contraindications for mild to moderate physical exertion
- Diagnosis of major medical or psychiatric disorder besides cancer (including but not limited to severe cardiovascular disease, epilepsy, uncontrolled diabetes, untreated hypothyroidism, delirium or dementia)
- Recurrence of colorectal cancer or other cancers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Intervention: Baduanjin qigong
This arm of participants will be receiving the Baduajin qigong intervention.
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The intervention consists of eight sequential forms of movements which is practiced with guidance on rhythmic breathing and mindful awareness.
Each cycle of the eight movements requires 10 to 15 minutes for completion.
Four cycles will be practiced in each session with short breaks arranged between them.
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EXPERIMENTAL: Intervention: Mindfulness meditation
This arm of participants will be receiving the Mindfulness meditation intervention.
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The intervention is developed based on the core components of the established Mindfulness-Based Stress Reduction and the Mindful Self-Compassion program with adaptation for local practice.
The focus of the group is to nurture mindful awareness, acceptance, and self-compassion.
The group sessions are composed of a combination of mindfulness-based practice, relaxation, and yoga exercise.
The basic philosophy of this intervention is the emphasis of the nurturing of self-kindness attitude, and non-attachment attitude towards inter-personal connectedness and letting go of self-criticism, need for control, and defensive separation in times of adversity.
Short breaks will be arranged between each practice.
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NO_INTERVENTION: Control
This arm of participants will not receive any intervention and are allocated as a Wait-list Control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Baseline Sleep Quality at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
Time Frame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Change of Baseline Cancer-related Symptom Distresses at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
Time Frame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Change of Baseline Health-related Quality of Life at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
Time Frame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Change from Baseline Anxiety and Depressive symptoms at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
Time Frame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Change of Baseline Perceived stress at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
Time Frame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Change of Baseline Mindfulness at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
Time Frame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Change of Baseline Salivary cortisol level at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
Time Frame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Change of Baseline Blood pressure at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
Time Frame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Measurement of both systolic and diastolic blood pressure.
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Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Change of Baseline Heart rate at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
Time Frame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Measurement of heart rate (beats per minute)
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Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
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Change of Week 1 Practice Compliance at Week 2 to 7 of intervention, and 6-month post-intervention
Time Frame: Week 1 to Week 7 of intervention, and 6-month Post intervention
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Practice Compliance will be measured by participants' daily duration (minutes per week) of qigong or mindfulness meditation practice at Week 2, 3, 4, 5, 6 and 7 during the course of intervention group, and 6-month post-intervention.
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Week 1 to Week 7 of intervention, and 6-month Post intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rainbow Tin Hung Ho, Department of Social Work and Social Administration, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17611615
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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