Colorectal CancerNCT03817489
Mindfulness Meditation and Qigong for Colorectal Cancer Survivors
A study testing Baduanjin qigong and Mindfulness meditation in people with Colorectal Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Baduanjin qigong and Mindfulness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Jan 2017to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Centre on Behavioral Health, The University of Hong Kong
Hong Kong
Adrian Ho Yin Wan, (852) 28315158, awan@hku.hk
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Baduanjin qigong, Mindfulness meditation
- Keywords
- Colorectal Cancer Survivors, Qigong, Mindfulness meditation, Randomized controlled trial, Cortisol
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin qigongBehavioural
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.
Mindfulness meditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Baduanjin qigong | Experimental | This arm of participants will be receiving the Baduajin qigong intervention. Receives: Behavioral: Baduanjin qigong |
| Intervention: Mindfulness meditation | Experimental | This arm of participants will be receiving the Mindfulness meditation intervention. Receives: Behavioral: Mindfulness meditation |
| Control | No intervention | This arm of participants will not receive any intervention and are allocated as a Wait-list Control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Baseline Sleep Quality at mid-intervention (week 4), post-intervention (week 8) and 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.
Measured: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
Change of Baseline Cancer-related Symptom Distresses at mid-intervention (week 4), post-intervention (week 8) and 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.
Measured: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
Change of Baseline Health-related Quality of Life at mid-intervention (week 4), post-intervention (week 8) and 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.
Measured: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
Change from Baseline Anxiety and Depressive symptoms at mid-intervention (week 4), post-intervention (week 8) and 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.
Measured: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
Change of Baseline Perceived stress at mid-intervention (week 4), post-intervention (week 8) and 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.
Measured: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
Change of Baseline Mindfulness at mid-intervention (week 4), post-intervention (week 8) and 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.
Measured: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
Change of Baseline Salivary cortisol level at mid-intervention (week 4), post-intervention (week 8) and 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.
Measured: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
Change of Baseline Blood pressure at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
Measurement of both systolic and diastolic blood pressure.
Measured: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
Change of Baseline Heart rate at mid-intervention (week 4), post-intervention (week 8) and 6-month post-intervention
Measurement of heart rate (beats per minute)
Measured: Baseline, Mid-Intervention (week 4), Post-intervention (week 8), 6-month Post-intervention
Change of Week 1 Practice Compliance at Week 2 to 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.
Measured: Week 1 to Week 7 of intervention, and 6-month Post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start4 Jan 2017
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Randomized Controlled Trail
- Masking
- None (open label)
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainbow Tin Hung Ho, Principal investigator, Department of Social Work and Social Administration, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817489
- Sponsor's protocol ID
- 17611615
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03817489
- Acronym / sponsor ID
- 17611615
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer Survivors, Qigong, Mindfulness meditation, Randomized controlled trial, Cortisol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Randomized Controlled Trail
| Arm | Type | Receives |
|---|---|---|
| Intervention: Baduanjin qigong | Experimental | Behavioral: Baduanjin qigongThis arm of participants will be receiving the Baduajin qigong intervention. |
| Intervention: Mindfulness meditation | Experimental | Behavioral: Mindfulness meditationThis arm of participants will be receiving the Mindfulness meditation intervention. |
| Control | No intervention | –This arm of participants will not receive any intervention and are allocated as a Wait-list Control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin qigongThe 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. | Behavioural | Intervention: Baduanjin qigong |
| Mindfulness meditationThe 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. | Behavioural | Intervention: Mindfulness meditation |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainbow Tin Hung Ho principal investigator
Department of Social Work and Social Administration, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin qigong and Mindfulness meditation in people with Colorectal Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rainbow Tin Hung Ho ((852) 28315158, tinho@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.