An interventional study of eMindExCare and Enhanced Health Education in Prostate Cancer, Sleep Disturbance and Fatigue, sponsored by The University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Supportive care
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the 8-week eMindExCare intervention delivered via Zoom. The intervention integrates culturally adapted Cantonese mindfulness practices with home-based aerobic and resistance exercise. Sessions will be delivered once weekly for 8 consecutive weeks, with home practice at least three times per week. Participants will receive a stationary bike, resistance band, mindfulness mat and zafu set, intervention videos, exercise logs, and WhatsApp or WeChat reminders.
Behavioral: eMindExCare
Participants will receive an 8-week enhanced health education attention-control programme delivered via Zoom. The programme will match the intervention group in contact time and engagement and will include cancer self-management education, basic breath-awareness or relaxation, and light non-progressive physical activity guidance. Participants will be encouraged to complete light relaxation or activity three times weekly and record this in a logbook. The programme will not include progressive aerobic training, resistance-band prescription, stationary bike provision, or a structured mindfulness curriculum.
Behavioral: Enhanced Health Education
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.
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.
Recruitment feasibility measured by eligibility rate
Eligibility rate will be calculated as the number of eligible patients divided by the number of patients screened.
Time frame: Through recruitment completion, up to 3 months
Recruitment feasibility measured by consent rate
Consent rate will be calculated as the number of eligible patients who provide informed consent divided by the number of eligible patients approached.
Time frame: Through recruitment completion, up to 3 months
Randomization feasibility measured by randomization rate
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
Time frame: Through recruitment completion, up to 3 months
Intervention attendance rate
Attendance rate will be calculated as the proportion of scheduled intervention or control sessions attended by each participant.
Time frame: Through completion of the 8-week intervention
Retention rate at post-intervention and follow-up
Retention rate will be calculated as the number of randomized participants who complete follow-up assessments divided by the number randomized.
Time frame: Immediately after the 8-week intervention and 3 months after the intervention
Acceptability of outcome data collection measured by questionnaire completion rate
Questionnaire completion rate will be calculated for each assessment time point and each outcome measure
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
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.
Time frame: Baseline, immediately after the 8-week intervention, and 3 months after the intervention
Subjective sleep quality
The Chinese Pittsburgh Sleep Quality Index includes 19 self-rated items across seven components. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality and scores of 5 or greater indicating clinically significant sleep disturbance.
Time frame: Baseline, immediately after the 8-week intervention, and 3 months after the intervention
Objective sleep parameters
Wrist actigraphy will objectively assess sleep parameters over 7 consecutive days, including sleep efficiency, total sleep time, sleep onset latency, wake time after sleep onset, and awakenings.
Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention
Physical activity
Wrist actigraphy will assess time spent in sedentary, light-intensity, moderate-intensity, vigorous-intensity, and very-vigorous-intensity activities. Data will be processed using ActiLife software and established cut-points.
Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention
Fatigue
The Chinese Brief Fatigue Inventory includes items assessing fatigue severity and fatigue interference using 0 to 10 numeric rating scales. Higher scores indicate more severe fatigue or greater interference.
Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention
Level of pain
The Chinese Brief Pain Inventory-Short Form assesses pain severity and pain interference using 0 to 10 numeric rating scales. Higher scores indicate greater pain severity or interference
Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention
Quality of well-being
The Chinese Functional Assessment of Cancer Therapy-Prostate includes 39 items covering physical, social, emotional, functional, and prostate cancer-specific well-being. Total scores range from 0 to 156, with higher scores indicating better quality of life.
Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention
Change in mindfulness
The Chinese Five Facet Mindfulness Questionnaire-15 includes 15 items rated on a 5-point Likert scale and assesses observing, describing, acting with awareness, non-judging, and non-reacting.
Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention
Change in exercise motivation
The Chinese Behavioural Regulation in Exercise Questionnaire-2 includes 18 items across amotivation, external regulation, introjected regulation, identified regulation, and intrinsic regulation.
Time frame: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention
Participant experiences and perceptions of the intervention
Semi-structured one-on-one interviews will explore participants' experiences, perceptions, acceptability, adherence, and feedback on the eMindExCare programme and study procedures.
Time frame: Immediately after the 8-week intervention
Plan to share: Yes — De-identified participant-level data underlying published results may be made available upon reasonable request to the principal investigator, subject to ethics approval, institutional policy, and a data sharing agreement.
Supporting information: Statistical analysis plan
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for May 2028, 19 months later.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 19 months is below that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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