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
Phase: NA
Conditions: Colorectal Cancer
Sponsor: The University of Hong Kong

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Study Protocol and Statistical Analysis Plan 
 
Unique Protocol ID: 17611615 
Brief Title: 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 
 
Document Creation Date: 16 Jan 2019  
 
 

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Research impact and objectives  
Long-term impact 
 
Colorectal cancer is the most prevalent form of cancer in Hong Kong[1]. Patients often suffer 
from physical symptoms such as fatigue, insomnia, constipation and diarrhea[2]. The 
physiological changes and emotional fluctuations can further lead to sleep disturbance[3] and 
loss of a sense of bodily control[4]. Depression and anxiety have prevalence ranging from 11%–
69% while rates remain high five years post-diagnosis[5]. Such physical and psychological 
symptoms relate closely to the dysregulation of circadian and cortisol rhythm [6] which may 
further predict poor quality of life and survival in colorectal cancer patients[7]. 
  
Popular Practices Remain Understudied 
To cope with physical and psychological concerns, cancer survivors turn to various mind-body 
practices adjuvant to the usual medical or pharmacological treatment for their holistic benefits 
and reduced side-effects[8, 9]. It has long been known that mind-body practices simultaneously 
cultivate the mind and body for overall health improvement and the treatment of chronic 
conditions[10]. Evidence for the effectiveness of highly popular local mind-body practices for 
cancer, like qigong or mindfulness meditation practices, are accumulating but limited by 
methodological flaws[11, 12].  
  
Understanding the Two Approaches to Mind-body Practices 
Most mind-body practices fall into two distinct categories: mind-based practices (i.e.mindfulness 
meditation, imagery), and body-based practices (i.e.qigong, taichi, yoga). These practices are 
typically studied independently; comparative effectiveness research was seldom conducted 
within or across two categories[13]. Others recognize their similar therapeutic components 
(e.g.breath regulation) and therapeutic goals (e.g.tranquility), leading to studies documenting 
interventions with mixed qigong and mindfulness meditation components[14]. 
  
Qigong and mindfulness meditation practices thus represent two very distinct forms of mind-
body practices which contrasted dynamic (resembling physical exercise) with static (still) 
practices though both attend to the mind, body and breath. Qigong is even connoted as a type of 
“mindful physical exercise” highlighting the similar underpinnings in introspection and mental 
cultivation qigong shares with mindfulness meditation[15]. A meta-analysis on qigong and taichi 
further found that it was the mental component of qigong rather than the physical exercise aspect 
contribute more on moderating the effects on anxiety or depression[16]. Interestingly, qigong 
relies on physical exertion to arrive at mental changes while mindfulness meditation begins 
directly at mental level but can also impact physical health. 

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The current study therefore, not only aims to provide evidence for the psychophysiological 
effectiveness of qigong and mindfulness meditation for colorectal cancer patients, but also 
to elucidate how the different entry-points of these two mind-body approaches differ in 
outcomes, balance the dysfunctional bodily stress response through the Hypothalamic- 
Pituitary-Adrenal (HPA) system and affect practice compliance in cancer patients. 
  
Theoretical contributions 
 
Despite the growing family of mind-body practices, few studies juxtaposed their differential 
outcomes, magnitude and pace of change and post-intervention compliance. Limitation of single-
intervention controlled studies was pointed out in a systematic review of mindfulness 
meditation[17]. This limitation contrasts the swift progression of psychosocial cancer research 
this decade where many studies were designed to compare amongst two or more related 
interventions to identify the uniqueness of interventional approaches[18]. Therefore, using a 
comparative randomized-controlled trial, this study is set out to further establish mind-body 
practices in psychosocial oncology by exploring the contrasting approaches with which qigong 
and mindfulness meditation exert their influences. 
  
Current knowledge on mind-body practices tells very little about these contrasting “dynamic 
moving bodily” versus “static mindful” approaches. This study will measure both physiological 
and psychological outcomes which offer a comprehensive understanding on the mental and 
bodily changes before, during, after each approach and their maintenance. 
   
In Traditional Chinese medicine, both movement-based and mind-based mind-body practices are 
known to have homeostatic functions to balance dysfunctional bodily systems. Examining the 
effects of mind-body practices on circadian cortisol rhythm may shed light on the homeostatic 
effect of mind-body practices on the dysregulation of the HPA system. 
  
Clinical contributions 
 
The clinical popularity of qigong and mindfulness meditation among local cancer survivors calls 
for a need for more established evidence on their benefits. Better understanding on culturally 
popular interventions, in particular, the common and unique effectiveness of different 
approaches are crucial, as patients and qualified healthcare professionals can select or provide 
practices which will produce maximum benefits, satisfaction, adherence, and sustainability. This 
study envisions bringing forth evidence-based mind-body practices which are easily learned, can 
be self-practiced and incorporated into patients’ lifestyles. 
 

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Objectives 
 
1.   Primary objective 1 is to study the effectiveness of Baduanjin qigong and Mindfulness 
mediation for Chinese colorectal cancer (CRC) patients as compared to a no-intervention 
control independently on: 
  (1) cancer-related symptoms and symptom distress 
  (2) mental health 
  (3) quality of life 
  (4) biomarkers 
  (5) mindfulness level 
  
2.   Primary objective 2 is to examine the commonalities and differential effectiveness 
between two interventions on: 
  (1) outcome variables 
  (2) magnitude of change 
  (3) pace of change 
  (4) extended compliance 
  
3.   Secondary objective is to examine the associations between psychological, physical and 
psychophysical markers and how those relationships change across the time points. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Background of the research 
 
The Reciprocity of the Mind and Body in Cancer  
Colorectal cancer impairs patients on multiple levels of well-being. While most physical 
symptoms can be managed by medication, psychosocial stressors may arise and persist to 
complicate survival and reduce quality of life of survivors[19]. Patients, especially those who 
requiring colostomy, suffer from psychosocial trauma including depression, the fear of relapse, 
altered self-image, loss of social functioning and connections[20]. Local statistics further 
indicated a high prevalence of elevated depressive symptoms (21.8%)[21].  
In recent years, research studies have emerged to suggest reciprocity between physical 
symptomatology and psychosocial stress of cancer patients. Evidence in psychoimmunology 
suggested that, for example, among those who are struggling with cancer, many who suffered 
from depressive symptoms reported sleep disturbance as well; and that sleep disturbance is a risk 
factor to depression and disease progression among cancer patients[22]. Other cancer studies 
have also clearly demonstrated mutually damaging effects of the body and mind[23]. Survival 
studies further highlight this connection where depression, anxiety, quality of life and other 
psychosocial factors predict survival among colorectal cancer patients[24]. Patients with high 
preoperative quality of life were 34.2% were more likely to survive 1 year after[25]. Given the 
psychological and prognostic importance of these factors, the need for psychosocial support 
which targets the reciprocal mind and body in colorectal cancer patients is warranted. 
 
Benefits of Mindfulness meditation and Qigong for Cancer Patients  
 
Evidence of Mind-body approaches for Cancer  
In view of the reciprocal suffering of the body and mind, there is an imminent need for 
effective interventions that would help people with cancer cope. For this reason, psychosocial 
interventions for cancer patients have been rapidly developing, and were put into rigorous 
empirical testing, over the past two decades. Evidence-based intervention strategies have been 
developed, such as cognitive-behavioral therapies, psycho-education interventions[26], social 
support groups[27, 28], and mindfulness-based stress reduction programs[12, 29, 30].   
A large number of research studies have demonstrated that mind-body intervention, in its 
various forms, have a beneficial effect on various aspects of psychological and physical 
functioning among people with cancer[29-31]. Mind-body practices like relaxation training, 
meditation, qigong, yoga, taichi and biofeedback, do not only improve functioning, reduce 
treatment- related nausea, vomiting, and physical pain, but also improve mood and quality of 
life[9, 32]. Although the mechanism of change of mind-body practices are not well known, one 
theory is that there is a relaxation response whereby autonomic activity is controlled and causes a 
decrease of sympathetic activation[33].   
The focus of this present study on Mindfulness Meditation and Qigong (Baduanjin) is 
due to an increasing popularity of practising these approaches among local cancer patients. This 
is coupled with marked evidence pertaining to safety, feasibility and effectiveness on various  
aspects of health in cancer patients.   

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Mindfulness meditation   
Mindfulness as a clinical practice refers to the intentional, accepting and non-judgmental  
focus of one's attention on the emotions, thoughts and sensations occurring in the present  
moment[34]. The well-known Mindfulness-based Stress Reduction, for instance, stemmed from  
the Buddhist view of universal suffering, the practice focuses on the development of mindful- 
awareness, non-judgmental mindset, and self-acceptance.   
One of the reasons why mindfulness-based intervention have been applied to cancer care 
is that there is a psychogenic basis for cancer. Immunological study yielded evidence to support 
the notion that cancer may be exacerbated or caused by stress, negative emotions, and sleep  
disturbance[22]. Secondly, the here-and-now orientation of mindfulness[30] moderate the  
sources of stress for people with cancer concerns about the past, such as the attribution of cancer  
causations, or regrets about past life decisions; while other sources of stress concerns about the  
future, such as enduring the suffering of pain, loss, and grief towards one’s own death. During  
meditation, the sense of time becomes plastic and each moment may serve as a timeless refuge  
from the inexorable demands of life as someone living with cancer[30]. A large number of  
research studies have demonstrated that mindfulness-based interventions have a beneficial effect  
on various aspects of psychological and physical functioning among people with cancer[29, 31].  
In a randomized controlled study, participants in the mindful mediation program resulted in less  
mood disturbance, tension, depressive symptoms, anger, problem in concentration, and more  
vigor at post-intervention when compared the control[35]. Participants also reported fewer stress  
symptoms, gastrointestinal symptoms, and sleep disturbance. Gains were sustainable after 6- 
months. Mindfulness mediation for cancer patients was also able to alter cortisol and immune  
patterns consistent with less stress and mood disturbance and decrease blood pressure in a 1-year  
follow up[36]. Locally, although study on the effectiveness of mindfulness on cancer patients is  
rare, results from studies on the effects of mindfulness on chronic pain, psychiatric symptoms  
and functioning are promising [37, 38]. 
 
Qigong  
Qigong consists of a mild form of muscular activity accompanied by an introspective and  
proprioceptive focus and an awareness of the flow of one’s intrinsic energy. According to  
Traditional Chinese Medicine, qigong aims at cultivating and enhancing qi which refers to the  
energy that can sustain health and well-being[39]. It also employs breath-centering techniques  
and fosters anatomic alignment through disciplined body movement[40]. Among the existing  
mindful exercises, Baduanjin qigong is one of the most popular forms which is formally  
recognized and recommended by General Administration of Sport of China. With only eight  
movements, it requires relatively less cognitive and physical effort[41] compared with tahichi  
and other forms of qigong. As such, the undemanding nature of Baduanjin qigong makes it a  
feasible intervention for a wide range of population, even for those who are less able due to old  
age and illness. Tsang and colleagues have carried out extensive research on the effect of  
Baduanjin qigong and have found promising results in its ability to improve depressive  
symptoms among elderly who suffered from chronic medical conditions[42]. Given its  
practicality and potential health benefits, qigong is also a popular mind-body therapy for cancer  
patients[43]. In support for its positive effect on cancer patients, a recent systematic review of 13  

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randomized control trials in this area[44] has concluded that, practicing qigong can help to  
improve cancer-specific quality of life, fatigue, immune function and cortisol level. This is  
largely in line with the result of a previous systematic review[11], particularly on its ability to  
boost immune function. In addition, Baduanjin qigong has been found to alleviate sleep  
disturbance[45], which is another common problem experienced by cancer patients. 
 
Need for Comparative Study of the Two Main Approaches in Mind-Body Practices  
The foregoing brief review suggests that mind-body practices like meditation and qigong  
benefit both physical and mental health albeit via different entry points. As discussed in earlier  
sections (Long-term impact), qigong and mindfulness meditation practices represent two very  
distinct approaches of mind-body practices. Although riding on the common component of  
focusing on breath, Chinese medical philosophies contrasted dynamic with static practices.  
Mind-based practices such as mindfulness meditation, relaxation or imagery are typically 
connoted as techniques to cultivate the mind’s ability to influence bodily function and  
symptoms[32], by means of focused-awareness training; while movement-based practices like  
qigong and yoga represent another category of health practice capitalizing on movement and  
attention to foster such mind-body connection via the physical body, by means of mild-moderate  
physical exercise with inner-directed focus.    
The review above is also suggestive of how most existing research on qigong and 
mindfulness meditation has thus far studied their effects independently, which calls for a need to 
provide comparative intervention research to elucidate how such contrasting approaches in mind-
body practices affect the psychosocial and physiological benefits as well as compliance on 
patients.   
 
Diurnal Cortisol rhythm and Cancer  
The hypothalamic-pituitary-adrenal (HPA) axis activity is responsible for the body’s 
reaction to stress and immune regulation. The dysfunction of the HPA axis in cancer patients 
reflected by the distortion of the diurnal cortisol rhythm is further associated with tumor 
characteristics and even survival[7, 46, 47]. Salivary cortisol is a neuroendocrine indicator of 
HPA axis. It is an established and reliable physiological marker for stress-related improvements 
after mindfulness and qigong practices[10, 48]. Yet, the limited handful of studies on 
mindfulness and qigong showed little consensus to establish its effects on cortisol patterns or 
levels[44, 48]. Meanwhile, a local study found a positive decreasing trend of cortisol after 
Baduanjin qigong with depressed elders with chronic medical illnesses[49]. Given the important 
implications of salivary cortisol on cancer, understanding the changes in cortisol profiles after 
qigong and meditation can further elucidate the linkage between mind-body practices with 
patients’ total well-being.  
 
Study Hypotheses  
1. Baduanjin qigong is more effective than no-intervention control in (i)reducing cancer-related 
symptoms and symptom distress, (ii)improving mental health, (iii)enhancing quality of life, 
(iv)positively altering biomarkers, (v)enhancing mindfulness level.   

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2. Mindfulness meditation is more effective than no-intervention control in similar areas and 
directionality as the above (i) to (v).  
3. There would be commonalities and differences between Baduanjin qigong and Mindfulness 
meditation in a)type of outcome variables, b)magnitude of change, c)time when significant 
outcomes emerge, d)frequency and length of self-practice and long-term compliance.  
4. The associations among physical and psychological variables as well as psychophysiological 
biomarkers and the changes of such associations across the time points are exploratory. 
 
Research Plan and Methodology 
 
Research design  
This study will utilize a 3-arm randomized controlled trial design with waitlist control. A  
conceptual model is provided in Appendix A. Upon recruitment, participants will be screened  
according to the inclusion and exclusion criteria (Appendix B). Baseline data will then be  
collected. Subsequently, eligible participants will be randomly assigned into one of the 8-week  
(i)Baduanjin qigong group, (ii)Mindfulness meditation group, and (iii)Waitlist Control group.  
The Waitlist Control group will continue to receive routine medical care and will have the option  
to attend either of the interventions after the study is completed. Participants from all 3 arms will  
be assessed on 4 time points (i)baseline prior randomization, (ii)mid-intervention (4th week),  
(iii)post intervention (8th week), (iii)6 months post-intervention. Participants will complete the  
study in 8 months.  
 
Sample size determination, Participant eligibility and Recruitment  
To achieve a statistical power of 0.8 with medium effect size (f2 = 0.25) and significance 
level of 0.05 in repeated measures MANOVA under the proposed 3-group, 4-time point design, a  
sample size of 126 is needed. Assuming an attrition rate of about 33.5%, based on prior trials on  
cancer patients using qigong[8], recruitment of 189 participants (63 per arm) is required.  
The study population will consist of 189 Chinese-speaking patients aged between 18 and 74,  
diagnosed with colorectal cancer. Participants will be recruited via posters and newsletters put up  
at hospital and community organizations servicing cancer patients including Hong Kong Anti- 
cancer society. Recruitment will also be done via referral from oncologists. Screening will be  
conducted after recruitment by a trained research assistant or by the referring medical  
professional based on the inclusion and exclusion criteria listed in Appendix B. 
 
Intervention groups  
Both intervention groups will consist of 8 weekly 90-minute sessions, with a total of 12 
contact hours. Interventions will be held in groups of about 10 participants led by 2 trainers 
qualified for the respective intervention form, one of whom will also be a mental health 
professional. 
 
a) The Baduanjin qigong Intervention[61] consist of eight sequential forms of movements which  
is practiced with guidance on rhythmic breathing and mindful awareness (see Appendix C for  
details). Each cycle of the eight movements requires 10 to 15 minutes for completion. Four  

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cycles will be practiced in each session with short breaks arranged between them. In addition to  
the in-session practices, participants are encouraged to practice Baduanjin qigong for at least 20  
minutes each day and keep a record of their daily practice in a log book.   
 
(b) The Mindfulness meditation Intervention which has been used by co-Is (C.L.W.Chan and  
Ng.S.M.) in previous studies 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[57, 62]. 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 (Appendix D). 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. Adjuvant  
to the in-session practices, participants are recommended to practice the mindful techniques  
every day for at least 20 minutes while keeping a record of their practice.  
 
(c) Waitlist control group members will continue with routine care and can join either the  
Baduanjin or Mindful intervention after the 6-month post-intervention assessment. 
 
Ethics  
This study will be reviewed by the HKU/HA Institutional Review Board. Written 
informed consent will be obtained from all participants. To ensure confidentiality, codes will be 
used to replace names. All data collected will be kept in locked spaces and destroyed 3 years 
after the study ends. The study will also be registered with the Hong Kong clinical trial registry.  
 
Measurements  
Assessments pertain to areas of (i)cancer-related symptoms and symptom distress, 
(ii)mental health, (iii)quality of life, (iv)biomarkers, (v)mindfulness, (vi)compliance, and 
(vii)demographic and clinical details. Self-rated scales and salivary cortisol are administered by 
participants themselves while blood pressure would be measured by the trained research assistant 
blinded to the randomization. Measurements are taken at all time points except demographic and 
clinical details.  
 
Cancer-related symptom, symptom distress and quality of life  
(a) Sleep quality. Quality of sleep will be indexed by the Pittsburgh Sleep Quality Index  
(PSQI)[63]. The PSQI is a self-report questionnaire that assesses multiple dimensions of 
sleep 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. The Chinese version of the PSQI was validated 
by the team and will be used[64]. 
 

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(b) Cancer-related symptom distress. Cancer-related symptoms distresses are measured by the 
Chinese version of Memorial Symptom Assessment Scale (MSAS)[65]. The scoring of the 
32-item MSAS yields a MSAS Global Distress Index (10 items) measuring of overall 
symptom distress; the Physical Symptom Subscale score (12 items); the Psychological 
Symptom Subscale score (6 items), a Total MSAS score.  
 
(c) Health-related Quality of life. This will be assessed using the Chinese (HK) Short form–12 
(SF-12)[66]. With 12 items, the scale results a physical and a mental health summary.   
 
Mental Health  
(d) Anxiety and depressive symptoms. Anxiety and depressive symptoms will be captured by 
the Cantonese/Chinese version of the Hospital Anxiety and Depression Scale (HADS)[67]. 
The 14-item scale consists of two subscales (anxiety and depression) with seven items in 
each. The items are scored on a 4-point Likert-type scale (0–3).   
 
(e) Perceived stress. Perceived stress levels will be assessed by the Chinese Perceived Stress  
Scale[68]. Using a 5-point Likert scale (0-4), the scale consists of 10 items about the degree 
to which life events are appraised as stressful.   
 
Biomarkers  
(f) Salivary cortisol. 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) using the collection device, Salivette, which 
includes a cotton swab to place under the tongue. Smoking, eating and drinking should be 
avoided and refrained one hour prior to saliva collection. Samples collected will be kept 
frozen at -20°C.Daily condition measures with salivary cortisol-Measures on participants’ 
health behaviors and activities on the day of saliva collection will be collected along with 
cortisol. These include (i)sleep quantity that day (hours of sleep at night and nap hours), 
(ii)subjective sleep quality rated on a scale of 1-10, (iii)smoking habit and the number of 
cigarettes that day (iv)alcohol/coffee drinking habit and the approximate amount that day, 
and (v)subjective evaluation of stress levels on the day of collection rated on a scale of 1-10. 
All the above measures will affect the diurnal cortisol rhythm and must be considered in 
analysis.  
 
(g) Blood pressure and heart rate. Following recommended procedures by the Canadian Medical 
Association[69], blood pressure and heart rates would be measured twice from each arm 
with a five minute rest intervals between measurements. The four collected readings will be 
averaged.   
 
(h) Mindfulness. The Chinese Five Facet Mindfulness Questionnaire (Short form) will be used 
upon permission. It has 5 domains, observing, describing, acting with awareness, nonjudging 
to inner experience and nonreacting to inner experience[70]. The 5-point Likert scale has 20 
items.  

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(i) Compliance. Participants will record their daily duration of qigong or mindfulness 
meditation practice over the course of the study. This will provide information on the 
frequency and intensity of practice, and maintenance of self-practice habits after the 
intervention period.  
 
(j) Demographics. Participants socio-demographic, such as age, gender, education level,  
employment status and marital status, as well as clinical profile, including cancer diagnosis, 
staging, treatment and medication record, onset of mood disturbances if any, critical events 
around the time of onset, physical exercise habits, complementary treatment used, and 
psychosocial support service utilization, will be documented based on self-report. 
 
Data analyses   
1. Effectiveness of Baduanjin qigong and Mindfulness meditation (Objective 1 & hypotheses 
1&2)  
 
Analysis of variance and chi-square independence tests will be carried out using SPSS to  
compare the demographic profile of the three groups. The study will use latent growth modeling  
(LGM) in Mplus 7 [71] to explore the effectiveness of the two mind-body interventions over the  
four assessment time points, between the respective experimental and waitlist control groups.  
Traditional analytic techniques such as ANOVA or MANOVA adopt traditional deletion or  
substitution methods and may not yield precise estimates in the presence of missing data. LGM  
flexibly analyzes the overall population trajectories using nonlinear modeling such as quadratic  
growth and the between-person variation in outcome variables, thus allows analysis of all  
available data via full information maximum likelihood under missing-at-random assumption.  
This matches the standard intent-to-treat analytic approach of clinical trials with missing data.  
The level of statistical significance is set at p=0.05, with p-values greater than 0.05 but smaller  
than 0.10 taken as marginal significance. All models are estimated using the robust maximum  
likelihood estimator.  
 
2. Commonalities and Differential effectiveness for Baduanjin qigong and Mindfulness  
meditation (Objective 2 and hypothesis 3).   
 
To examine the commonalities and differential effectiveness for Baduanjin qigong and  
Mindfulness meditation, treatment effects of the two interventions are directly compared in  
multigroup conditional growth models. The linear slope factors of the outcomes are contrasted  
across the two intervention groups via computing the difference in the intercepts of the slope  
factors between two groups using Model Constraint option. Demographic and clinical  
characteristics that differed significantly across the three groups in the preliminary analysis are  
entered as covariates. Influential confounding variables such as clinical prognosis or frequency,  
intensity and duration of maintenance (compliance) of practice will be controlled.  
 
3. The Mind-body correlations reflected in symptoms and psychophysiological markers  
(Objective 3 and hypothesis 4).   
 
Employing baseline data from both the experimental and control groups, correlation 
analyses will be used to understand the relationship between the parameters reflected on the 

12 
 
 
 
mind and body which include diurnal cortisol patterns, subjective stress and assessments on the  
psychological symptoms, sleep patterns, health-related quality of life. Changes of those  
associations across time can be analyzed by latent growth modeling using Mplus.  
 
4. Analysis of salivary cortisol data (for all objectives and hypotheses)  
 
Saliva samples will be centrifuged at 3000rpm for 15 minutes at room temperature. Cortisol  
levels will be determined with an enzyme-linked immunoabsorbent assay kit (EIA, Salimetrics,  
Inc) in the HKU Clinical Oncology Lab. The assay sensitivity is 0.193 nmol/l and the intra-assay  
and inter-assay coefficients of variation are 3% and 10% respectively. Due to the skewed  
distribution of salivary cortisol data, natural logarithm will be used to transform the raw cortisol  
data to yield an unskewed distribution for analysis. The mean cortisol level will average the 5  
collected across the day and total cortisol level is measured by the area under the curve.  
 
To explore individual trajectories of changes in cortisol level over time and also the complex  
relationships between different variables, a two-level individual growth curve model using  
Mplus software will be adopted as cortisol measures at 5 daily time points are nested within  
participants. This method is a variant of multiple regression modeling appropriate for the nested  
structure of our data. 
 
 

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Appendix A: Conceptual model of the proposed study
Appendix B: Inclusion and exclusion criteria
Inclusion Criteria
Exclusion 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
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
Clinical Factors
Cancer diagnosis and
staging
Treatment and medication
Baseline Mood
disturbances
Physical exercise habits
Psychosocial support
services
Sociodemographic Factors
Age
Gender
Education level
Employment status
Marital status
Interventions
(a) Baduanjin Qigong
Intervention group (8
weekly sessions, 90 minutes
each)
(b) Mindfulness meditation
intervention group (8
weekly sessions, 90 minutes
each)
(c) No intervention waitlist
control group
Outcomes
Cancer-related symptoms,
symptom distress &
well-being
1. Cancer-related symptom
distress
2. Sleep quality
3. Health-related quality of
life
Mental health
4. Anxiety and depressive
symptoms
5. Perceived stress levels
Biomarkers
6. Salivary cortisol
7. Blood pressure and heart
rate
Mindfulness
8. Observing, Describing,
Awareness, Non-judging,
Non-reacting
Compliance
Frequency and intensity of
qigong or mindfulness
meditation self-practice
(outside of intervention
groups and after
intervention period)
Duration of maintenance of
self-practice habit after
intervention period
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Appendix C: The 8 Movements of Baduanjin Qigong Programme
Appendix D: Main components of the Mindfulness Meditation Program
1. Introduction to Mindfulness
2. Practising mindfulness meditation
3. Practising loving-kindness meditation
4. Developing self-love through mindfulness meditation
5. Exploring meaning in life through mindfulness application
6. Bringing in difficult emotions
7. Practising self-kindness and gratitude as way of coping wrong difficult emotions
and difficult situations in life
8. Transferring mindfulness meditation as a way of living
1.Holding up the sky with both hands to regulate
the triple warmer
2.Draw a bow on both sides like shooting a
vulture
3.Raise single arm to regulate spleen and stomach
4.Look back to treat five strains and seven
impairments
5.Sway head and buttocks to expel heart-fire
6.Pull toes with both hands to reinforce kidney
and waist
7.Clench fists and look with eyes wide open to
build up strength and stamina
8. Rise and fall on tiptoes to dispel all diseases
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