Clinical trial NCT05778708: Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients
Official title: Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Lung Non-Small Cell Carcinoma
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
First posted: 2023-03-21
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized controlled trial is to investigate the effects of Tai-Chi and aerobic exercise on the emotional symptom cluster, and the underlying mechanism of that cluster, in late-stage lung cancer patients. Participants will be randomized into one of three groups: 1) Tai-Chi group, 2) aerobic exercise group, or 3) self-management control group. Both the Tai-Chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). The self-management control group will receive written information regarding the recommended level of physical activity.

Detailed description: Late-stage lung cancer patients (n = 318) meeting the inclusion criteria will be recruited and randomized into one of three groups: 1) Tai-Chi group, 2) aerobic exercise group, or 3) self-management control group. Both the Tai-Chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). The self-management control group will receive written information regarding the recommended level of physical activity. To evaluate the effectiveness of Tai-Chi and aerobic exercise in alleviating the emotional symptom cluster (primary outcome) and individual symptoms (sleep disturbance, anxiety, depression, fatigue), outcome measures will be conducted at baseline, 8 weeks (mid-point assessment), 16 weeks (post-intervention), and 28 weeks (12-weeks post-intervention). A linear mixed-effects model will be used to study the between-group differences in outcomes. In addition, emotion regulation, mindfulness, and cardiorespiratory fitness will be evaluated at each data collection point, and structural equation modeling will be used for subsequent mediation analysis to determine their mediating role in outcome changes. Qualitative interviews will be conducted to understand patients' experience and evaluation of the interventions.

Eligibility criteria: Inclusion Criteria:

* diagnosed with stage IIIB or IV non-small cell lung cancer confirmed by pathology, with no other cancer diagnosis within the previous year;
* a current Eastern Cooperative Oncology Group Performance Status of 0-2;
* experience of sleep disturbance, anxiety, depression, and fatigue in the past week (rating of 1 or more on a 0-10 numeric rating scale \[NRS\] for each symptom);
* able to communicate in Cantonese, Mandarin, or English;
* conscious and alert

Exclusion Criteria:

* suffering from a condition that hinders exercise performance (e.g., active neurological disorder, recent heart attack);
* currently participating in any other exercise or mind-body classes; or 3) performing regular exercises, defined as at least 150 minutes of moderate-intensity exercise weekly

Primary outcomes:
measure: Change from Baseline Emotional symptom cluster at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Emotional symptom cluster at 16 weeks
timeFrame: 16 weeks
measure: Change from Baseline Emotional symptom cluster at 28 weeks
timeFrame: 28 weeks
Secondary outcomes:
measure: Change from Baseline Sleep disturbance at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Sleep disturbance at 16 weeks
timeFrame: 16 weeks
measure: Change from Baseline Sleep disturbance at 28 weeks
timeFrame: 28 weeks
measure: Change from Baseline Fatigue at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Fatigue at 16 weeks
timeFrame: 16 weeks
measure: Change from Baseline Fatigue at 28 weeks
timeFrame: 28 weeks
measure: Change from Baseline Anxiety and depression at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Anxiety and depression at 16 weeks
timeFrame: 16 weeks
measure: Change from Baseline Anxiety and depression at 28 weeks
timeFrame: 28 weeks
measure: Change from Baseline Emotion regulation at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Emotion regulation at 16 weeks
timeFrame: 16 weeks
measure: Change from Baseline Emotion regulation at 28 weeks
timeFrame: 28 weeks
measure: Change from Baseline Mindfulness at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Mindfulness at 16 weeks
timeFrame: 16 weeks
measure: Change from Baseline Mindfulness at 28 weeks
timeFrame: 28 weeks
measure: Change from Baseline Cardiorespiratory fitness at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Cardiorespiratory fitness at 16 weeks
timeFrame: 16 weeks
measure: Change from Baseline Cardiorespiratory fitness at 28 weeks
timeFrame: 28 weeks
measure: Change from Baseline agility at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline agility at 16 weeks
timeFrame: 16 weeks
measure: Change from Baseline agility at 28 weeks
timeFrame: 28 weeks
measure: Change from Baseline strength at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline strength at 16 weeks
timeFrame: 16 weeks
measure: Change from Baseline strength at 28 weeks
timeFrame: 28 weeks
measure: Change from Baseline balance at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline balance at 16 weeks
timeFrame: 16 weeks
measure: Change from Baseline balance at 28 weeks
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Chia-Chin Lin, PhD,FAAN,RN
role: PRINCIPAL_INVESTIGATOR
References: