Mindfulness Meditation and Qigong for Colorectal Cancer Survivors

• ClinicalTrials.gov Identifier: NCT03817489
• Recruitment Status: Unknown
• First Posted: January 25, 2019
• Last Update Posted: January 30, 2020
• Sponsor: The University of Hong Kong
• Information provided by (Responsible Party): The University of Hong Kong

Study Description

Brief Summary:

Colorectal cancer imposes threats to patients' well-being. Although most physical symptoms can be managed by medication, psychosocial stressors may complicate survival and hamper quality of life. Mindfulness and Qigong, two kinds of mind-body exercise rooted in Eastern health philosophy, has been found effective in symptoms management, improving mental health, and reducing stress. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the comparative effectiveness of mindfulness and Baduanjin intervention on the bio-psychosocial wellbeing of people with colorectal cancer. A 3-arm RCT with waitlist control design will be used in this study. One hundred eighty-nine participants will be randomized into (i) Mindfulness, (ii) Baduanjin, or (iii) waitlist control groups. Participants in both the Baduanjin and mindfulness groups will receive 8-weeks of specific intervention. All three groups will undergo four assessment phases: (i) at baseline, (ii) at 4-week, (iii) at 8-week (post-intervention), and (iv) 6-month post-intervention (maintenance). All participants will be assessed in terms of cancer-related symptoms and symptom distress, mental health status, quality of life, stress level based on physiological marker. Based on prior research studies, participants in both the mindfulness and Baduanjn intervention group are expected to have better symptoms management, lower stress level, better mental health, and higher level of quality of life than the control group. This study contributes to better understanding on the common and unique effectiveness of mindfulness and Baduanjin qigong, as such patients and qualified healthcare professionals can select or provide practices which will produce maximum benefits, satisfaction, adherence, and sustainability.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Behavioral: Baduanjin qigong; Behavioral: Mindfulness meditation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 189 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel Randomized Controlled Trail
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 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
• Actual Study Start Date: January 4, 2017
• Estimated Primary Completion Date: October 30, 2020
• Estimated Study Completion Date: October 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention: Baduanjin qigong; This arm of participants will be receiving the Baduajin qigong intervention.	Behavioral: Baduanjin qigong; 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.
Experimental: Intervention: Mindfulness meditation; This arm of participants will be receiving the Mindfulness meditation intervention.	Behavioral: Mindfulness meditation; 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.
No Intervention: Control; This arm of participants will not receive any intervention and are allocated as a Wait-list Control group.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   • Administration of the Chinese version of Pittsburgh Sleep Quality Index (PSQI)
   • The PSQI is a self-report questionnaire that assesses multiple dimensions of seep over past one month.
   • The 19-item scale generates 7 'component' scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of the seven component scores yields one global score of subjective sleep.
2. 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 ]
   • Administration of the the Chinese version of Memorial Symptom Assessment Scale (MSAS)
   • The scoring of the 32-item MSAS yields a MSAS Global Distress Index (10 items), the Physical Symptom Subscale score (12 items), the Psychological Symptom Subscale score (6 items), and a Total MSAS score.
3. 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 ]
   • Administration of the Chinese (HK) version of the Short form-12 (SF-12)
   • This scale results in a physical and a mental health summary.
4. 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 ]
   • Administration of the Cantonese/Chinese version of the Hospital Anxiety and Depression Scale (HADS)
   • The 14-item scale consists of two subscales (anxiety and depression) with seven items in each.
5. 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 ]
   • Administration of the Chinese Perceived Stress Scale
   • This scale consists of 10 items about the degree to which life events are appraised as stressful.
6. 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 ]
   • Administration of the Chinese Five Facet Mindfulness Questionnaire (Short form)
   • This scale has 5 domains, observing, describing, acting with awareness, nonjudging to inner experience and nonreacting to inner experience.
7. 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 ]
   • Salivary cortisol collection will be conducted by participants themselves.
   • Saliva samples will be collected at 5 prescribed times (awakening, 45 minutes post-awakening, 12:00pm, 5:00pm and 9:00pm) by placing a cotton swab under the tongue.
8. 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 ]
   Measurement of both systolic and diastolic blood pressure.
9. 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 ]
   Measurement of heart rate (beats per minute)
10. 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 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Rainbow Tin Hung Ho; (852) 28315158; tinho@hku.hk

Locations

Hong Kong

Centre on Behavioral Health, The University of Hong Kong; Recruiting

Hong Kong, Hong Kong

Contact: Adrian Ho Yin Wan (852) 28315158 awan@hku.hk

Sponsors and Collaborators

The University of Hong Kong

Investigators

• Principal Investigator: Rainbow Tin Hung Ho; Department of Social Work and Social Administration, The University of Hong Kong

  Study Documents (Full-Text)

Documents provided by The University of Hong Kong:

Study Protocol and Statistical Analysis Plan  [PDF] January 16, 2019

More Information

• Responsible Party: The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT03817489
• Other Study ID Numbers: 17611615
• First Posted: January 25, 2019
• Last Update Posted: January 30, 2020
• Last Verified: January 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Hong Kong:

Colorectal Cancer Survivors; Qigong; Mindfulness meditation; Randomized controlled trial; Cortisol

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases