eMindExCare for Prostate Cancer Patients Undergoing Active Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eMindExCare, Enhanced Health Education.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Sleep Disturbance, Fatigue, Physical Inactivity. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
The primary objective is to assess the feasibility and acceptability of implementing eMindExCare in prostate cancer patients undergoing active treatment in the Hong Kong context. The secondary objective is to estimate preliminary effects on sleep quality, fatigue, pain, physical activity, mindfulness, exercise motivation, and quality of life. A process evaluation using semi-structured interviews will explore participants' experiences, perceptions, and feedback to refine the programme before a larger randomized controlled trial.
Interventions
- Behavioral eMindExCare
An integrated mindfulness and exercise eHealth intervention for prostate cancer patients undergoing active treatment. The programme includes mindfulness practice, moderate-intensity aerobic activity such as stationary cycling or walking, resistance-band exercises, home practice, intervention videos, and adherence/safety monitoring through exercise logs and weekly reminders. - Behavioral Enhanced Health Education
A Zoom-delivered attention-control programme including 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.
Primary outcome measures
- Recruitment feasibility measured by eligibility rate [Time frame: Through recruitment completion, up to 3 months]
- Recruitment feasibility measured by consent rate [Time frame: Through recruitment completion, up to 3 months]
- Randomization feasibility measured by randomization rate [Time frame: Through recruitment completion, up to 3 months]
- Intervention attendance rate [Time frame: Through completion of the 8-week intervention]
- Retention rate at post-intervention and follow-up [Time frame: Immediately after the 8-week intervention and 3 months after the intervention]
- Acceptability of outcome data collection measured by questionnaire completion rate [Time frame: Baseline, immediately after the 8-week intervention, and 3 months after the intervention]
- Acceptability of outcome data collection measured by missing data rate [Time frame: Baseline, immediately after the 8-week intervention, and 3 months after the intervention]
Secondary outcome measures (8)
- Subjective sleep quality [Time frame: Baseline, immediately after the 8-week intervention, and 3 months after the intervention]
- Objective sleep parameters [Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention]
- Physical activity [Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention]
- Fatigue [Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention]
- Level of pain [Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention]
- Quality of well-being [Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention]
- Change in mindfulness [Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention]
- Change in exercise motivation [Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital, Urology Division — Hong Kong
Identifiers
NCT: NCT07735273 · 23241311