Clinical trial NCT04119778: Improving Sleep in Lung Cancer Patients: A Trial of Aerobic Exercise and Tai-chi
Official title: Improving Sleep in Lung Cancer Patients: A Randomized Controlled Trial of Aerobic Exercise and Tai-chi Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lung cancer is one of the commonest cancers around the world. Sleep disturbances are commonly reported by lung cancer patients. Meanwhile, disturbed sleep is associated with several health problems, including shortened survival period. Thus, lung cancer imposes a substantial health burden on patients and society both locally and world widely. On top of the classical clinical therapies, additional approaches that could result in improved sleep are needed.

Previous studies, including our own, have shown that physical exercise, such as aerobic walking, improves lung cancer patient's physical fitness particularly cardiovascular fitness, circadian rhythm and immune function. Another popular mode of exercise in Chinese population is tai-chi. With emphasis on breathing and concentration, tai-chi exhibits extra benefits for stress-relieving and psychological well-being. Those benefits of exercise have long been implicated for better sleep of cancer patients. The promising benefits of aerobic exercise or tai-chi, as non-pharmacological interventions, urge for need of rigorous evidence on the effectiveness of these interventions in improving sleep outcomes. However, to date, there has been no report from a randomized controlled trial (RCT) to study the effect of aerobic exercise or tai-chi on sleep of lung cancer patients.

This proposed research is designed to conduct a three-arm RCT comparing aerobic exercise, tai-chi to usual care in non-small cell lung cancer patients. Recruited participants will be randomised into three groups: 1) a 16-week aerobic exercise group, 2) a 16-week tai-chi program group, and 3) a self-management control group. Aerobic exercise and tai-chi program will be conducted by certificated coaches. Life-long adherence to the practice in intervention groups is encouraged.

Through this project, the investigators aim to evaluate if 1) aerobic exercise or 2) tai-chi intervention promote subjective sleep quality in lung cancer patients compared to control, as the primary outcome of this study. The investigators shall also examine if tai-chi practice can provide similar improvement in sleep quality compared with ordinary exercise. Using biomarkers including circadian rhythm, cardio-respiratory fitness, further provides objective measures for bio-physiological effectiveness of the interventions. The associations of those biological measures and psycho-social status with sleep outcomes will be further explored.

Findings of this study will provide crucial information on the evidence-based practice by physical exercise or tai-chi to improve sleep of lung cancer patients. This study will also have far-reaching significance in providing important scientific evidence to policymakers to integrate physical activity into routine clinical management as an add-on treatment for lung cancer patients in Hong Kong.


Eligibility criteria: Inclusion Criteria:

1. Patients who are diagnosed of stage IIIB, or IV non-small-cell lung cancer confirmed by pathology
2. Patients are not currently engaged in other research or participant in any other exercise or mind-body classes
3. Patients aged 18 years old, or above
4. Patients who can communicate in Cantonese, Mandarin
5. Patients with no other cancer diagnosis within the previous 1 year
6. Patients report not doing regular exercises (defined \<150 min of moderate-intensity exercise weekly) in daily living, but are able to attend either exercise or tai-chi classes at scheduled times
7. Patients with ECOG 0-1
8. Patients being conscious and alert.
9. Patients who can read and write in Chinese

Exclusion Criteria:

* Patients suffering from a diagnosed active neurological, substance abuse and /or psychiatric disorders (i.e. depression, chronic insomnia)。

Primary outcomes:
measure: Quality of Sleep (Subjective)- Pittsburgh Sleep Quality Index
timeFrame: 1 year
Secondary outcomes:
measure: Levels of physical activity
timeFrame: Baseline, 16-week, 1 year
measure: Circadian rhythms- cortisol rhythms
timeFrame: Baseline, and 1 year
measure: Circadian rhythms- melatonin rhythms
timeFrame: Baseline, and 1 year
measure: Cardio-respiratory fitness- 6-minute walking test
timeFrame: Baseline, 16-week, 1 year
measure: Physical functioning- Get Active Questionnaire
timeFrame: Baseline, 16-week, 1 year
measure: Physical functioning- timed up and go test
timeFrame: Baseline, 16-week, 1 year
measure: Physical functioning-sit to stand test
timeFrame: Baseline, 16-week, 1 year
measure: Physical functioning- single leg standing test
timeFrame: Baseline, 16-week, 1 year
measure: Immune functions- cytotoxic activity of natural killer (NK) cells, and spontaneous or phytohemagglutinin (PHA)-stimulated T-lymphocyte proliferation
timeFrame: Baseline, 1 year
measure: Health-related quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire
timeFrame: Baseline, 16-week, 1 year
measure: Health-related quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Core corresponding lung cancer-specific module
timeFrame: Baseline, 16-week, 1 year
measure: Psychological Distress- Hospital Anxiety and Depression Score
timeFrame: Baseline, 16-week, 1 year
measure: Fatigue- Brief Fatigue Inventory
timeFrame: Baseline, 16-week, 1 year
measure: Quality of Sleep (Objective)- Actigraph
timeFrame: Baseline, 16-week, 1 year
measure: Fried frailty Criteria
timeFrame: Baseline, 16-week, 1 year
measure: One-year survival rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References:
citation: Takemura N, Cheung DST, Fong DYT, Lee AWM, Lam TC, Ho JC, Kam TY, Chik JYK, Lin CC. Relationship of subjective and objective sleep measures with physical performance in advanced-stage lung cancer patients. Sci Rep. 2021 Aug 26;11(1):17208. doi: 10.1038/s41598-021-96481-7.