Clinical trial NCT03817489: Mindfulness Meditation and Qigong for Colorectal Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer Survivors
Qigong
Mindfulness meditation
Randomized controlled trial
Cortisol
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Randomized Controlled Trail
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change of Baseline Sleep Quality at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
timeFrame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
measure: Change of Baseline Cancer-related Symptom Distresses at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
timeFrame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
measure: Change of Baseline Health-related Quality of Life at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
timeFrame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
measure: Change from Baseline Anxiety and Depressive symptoms at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
timeFrame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
measure: Change of Baseline Perceived stress at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
timeFrame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
measure: Change of Baseline Mindfulness at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
timeFrame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
measure: Change of Baseline Salivary cortisol level at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
timeFrame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
measure: Change of Baseline Blood pressure at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
timeFrame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
measure: Change of Baseline Heart rate at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
timeFrame: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
measure: Change of Week 1 Practice Compliance at Week 2 to 7 of intervention, and 6-month post-intervention
timeFrame: Week 1 to Week 7 of intervention, and 6-month Post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre on Behavioral Health, The University of Hong Kong
Study officials:
affiliation: Department of Social Work and Social Administration, The University of Hong Kong
name: Rainbow Tin Hung Ho
role: PRINCIPAL_INVESTIGATOR
References: