Mindfulness Meditation and Qigong for Colorectal Cancer Survivors

NCT03817489 | Unknown

• 1 other identifier: 17611615
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  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.

  Week 1 to Week 7 of intervention, and 6-month Post intervention

Study Arms (3)

Intervention: Baduanjin qigong

EXPERIMENTAL

This arm of participants will be receiving the Baduajin qigong intervention.

Behavioral: Baduanjin qigong

Intervention: Mindfulness meditation

EXPERIMENTAL

This arm of participants will be receiving the Mindfulness meditation intervention.

Behavioral: Mindfulness meditation

Control

NO INTERVENTION

This arm of participants will not receive any intervention and are allocated as a Wait-list Control group.

Interventions

Baduanjin qigong BEHAVIORAL

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.

Intervention: Baduanjin qigong

Mindfulness meditation BEHAVIORAL

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.

Intervention: Mindfulness meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary colorectal cancer of any stages 0 to III
• An expected survival length of 12 months or longer
• to 5 years following completion of main treatment for colorectal cancer
• Ages 18 or higher
• Chinese speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Centre on Behavioral Health, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rainbow Tin Hung Ho

  Department of Social Work and Social Administration, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rainbow Tin Hung Ho

CONTACT

(852) 28315158; tinho@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Randomized Controlled Trail

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 25, 2019
• Study Start: January 4, 2017
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: January 30, 2020

Record last verified: 2020-01

Locations

HK (1)