Effects of Integrated Mindfulness and Exercise eHealth Intervention (eMindExCare) on Sleep, Fatigue, and Physical Activity Among Prostate Cancer Patients Undergoing Active Treatment: A Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recruitment feasibility measured by eligibility rate
研究概览
简要总结
This feasibility randomized controlled trial will assess the acceptability, feasibility, and preliminary effects of an integrated mindfulness and exercise eHealth intervention, eMindExCare, among prostate cancer patients undergoing active treatment in Hong Kong. Participants will be randomized in a 1:1 ratio to either an 8-week eMindExCare intervention or an enhanced health education attention-control programme. eMindExCare integrates culturally adapted Cantonese mindfulness practices with home-based aerobic and resistance exercise delivered through Zoom, supported by home practice, exercise logs, and weekly reminders. The enhanced health education control programme will match the intervention group in contact time and engagement but will not include progressive aerobic training, resistance-band prescription, stationary bike provision, or a structured mindfulness curriculum. Feasibility and acceptability outcomes will include eligibility, consent, randomization, attendance, retention, questionnaire completion, missing data, and adverse events. Preliminary outcomes will include sleep quality, fatigue, pain, physical activity, mindfulness, motivation for exercise, and quality of life assessed at baseline, immediately post-intervention at week 8, and 3 months post-intervention.
详细描述
Prostate cancer patients undergoing active treatment commonly experience interrelated symptoms, including sleep disturbance, fatigue, pain, and reduced physical activity. These symptoms may negatively affect physical functioning, psychological well-being, and quality of life. Mindfulness-based approaches may improve sleep quality and coping, while aerobic and resistance exercise may reduce fatigue, pain, and physical inactivity. However, these approaches are often delivered separately, and there is limited evidence on integrated mindfulness and exercise eHealth interventions for men with prostate cancer.
The eMindExCare programme was developed based on mindfulness-based cancer recovery principles, exercise and cancer guidelines, previous literature, and the study team's systematic reviews of exercise and mindfulness interventions. The programme is informed by the mindful coping model and self-determination theory. It aims to promote adaptive coping, present-moment awareness, intrinsic motivation for health behaviour change, and competence in practicing mindfulness and physical activity.
eMindExCare will be delivered online through Zoom over 8 consecutive weeks. Each weekly session will last approximately 60 minutes and will include a brief introduction, mindfulness practice, aerobic/resistance exercise, and sharing or discussion. The first session will be delivered in small groups of three to four participants to introduce the programme and explain how mindfulness and exercise may help manage cancer-related symptoms. The remaining sessions will be delivered individually, with follow-up and reminders through WhatsApp or WeChat. Participants will be encouraged to complete home-based practice at least three times per week for approximately 30 minutes. Intervention participants will be provided with a stationary bike, resistance band, mindfulness mat and zafu set, and mindfulness and exercise videos to support home practice.
Exercise will be delivered at a low-to-moderate intensity, approximately Borg Rating of Perceived Exertion 11-13, or a level at which participants can talk but not sing. Exercise intensity will be gradually progressed. Aerobic exercise will include stationary cycling or walking, and resistance training will use elastic bands to work major muscle groups. Participants will record daily practice and homework in a standardized exercise log.
Participants in the control group will receive an enhanced health education attention-control programme delivered via Zoom. The programme will include cancer self-management education, basic breath-awareness or relaxation, and light non-progressive physical activity guidance such as posture, gentle stretching, walking tips, and sit-to-stand activities. It will match the intervention group in contact time and engagement but will not include the structured eMindExCare mindfulness curriculum or progressive aerobic/resistance exercise prescription.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participants and intervention providers cannot be blinded. Outcome data collectors and data analysts will remain blinded to group allocation where feasible. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes opened after baseline data collection
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with prostate cancer, stage I, II, or III.
- •Aged older than 18 years.
- •Undergoing active treatment, including chemotherapy, radiotherapy, or hormone therapy, at Prince of Wales Hospital.
- •Able to communicate and read Chinese.
- •Has access to the Internet and a computer or tablet.
- •Demonstrates clinically impaired sleep quality or insufficient physical activity as measured by ActiGraph. Clinically impaired sleep quality may include study-defined sleep disturbance criteria such as total sleep time less than 6.5 hours, sleep onset latency greater than 30 minutes, awakenings lasting greater than 5 minutes, or wake after sleep onset greater than 30 minutes.
排除标准
- •Diagnosed with more than one primary cancer.
- •Has metastatic disease.
- •Has participated in a mindfulness programme.
- •Is sufficiently physically active at the time of recruitment.
- •Has a mental condition, World Health Organization/Eastern Cooperative Oncology Group performance status greater than 2, a physical disability that prevents participation in the intervention, or any other health problem that rules out regular physical activity as determined by the treating physician.
结局指标
主要结局
Recruitment feasibility measured by eligibility rate
时间窗: Through recruitment completion, up to 3 months
Eligibility rate will be calculated as the number of eligible patients divided by the number of patients screened.
Recruitment feasibility measured by consent rate
时间窗: Through recruitment completion, up to 3 months
Consent rate will be calculated as the number of eligible patients who provide informed consent divided by the number of eligible patients approached.
Randomization feasibility measured by randomization rate
时间窗: Through recruitment completion, up to 3 months
Randomization rate will be calculated as the number of participants randomized divided by the number of participants who provide informed consent and complete baseline procedures
Intervention attendance rate
时间窗: Through completion of the 8-week intervention
Attendance rate will be calculated as the proportion of scheduled intervention or control sessions attended by each participant.
Retention rate at post-intervention and follow-up
时间窗: Immediately after the 8-week intervention and 3 months after the intervention
Retention rate will be calculated as the number of randomized participants who complete follow-up assessments divided by the number randomized.
Acceptability of outcome data collection measured by questionnaire completion rate
时间窗: Baseline, immediately after the 8-week intervention, and 3 months after the intervention
Questionnaire completion rate will be calculated for each assessment time point and each outcome measure
Acceptability of outcome data collection measured by missing data rate
时间窗: Baseline, immediately after the 8-week intervention, and 3 months after the intervention
The proportion of missing data will be calculated for each questionnaire and assessment time point. The feasibility criterion is missing data of 20% or less.
次要结局
- Subjective sleep quality(Baseline, immediately after the 8-week intervention, and 3 months after the intervention)
- Objective sleep parameters(Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention)
- Physical activity(Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention)
- Fatigue(Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention)
- Level of pain(Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention)
- Quality of well-being(Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention)
- Change in mindfulness(Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention)
- Change in exercise motivation(Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention)