Fatigue, Pain, Physical Inactivity, Prostate Cancer, Sleep Disturbance
Conditions
Keywords
Prostate Cancer, prostate neoplasms, eMindExCare, mindfulness, exercise, physical activity, eHealth, sleep quality, sleep disturbance, fatigue, pain, quality of life, feasibility trial, pilot randomized controlled trial, Hong Kong
Brief summary
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
BEHAVIORALeMindExCare
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.
BEHAVIORALEnhanced 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.
Sponsors
The University of Hong Kong
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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
Intervention model description
Single-blind, parallel, two-arm feasibility randomized controlled trial comparing eMindExCare with an enhanced health education attention-control programme.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with prostate cancer, stage I, II, or III. 2. Aged older than 18 years. 3. Undergoing active treatment, including chemotherapy, radiotherapy, or hormone therapy, at Prince of Wales Hospital. 4. Able to communicate and read Chinese. 5. Has access to the Internet and a computer or tablet. 6. 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
1. Diagnosed with more than one primary cancer. 2. Has metastatic disease. 3. Has participated in a mindfulness programme. 4. Is sufficiently physically active at the time of recruitment. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment feasibility measured by eligibility rate | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective sleep quality | Baseline, immediately after the 8-week intervention, and 3 months after the intervention | 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. |
| Objective sleep parameters | Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention | 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. |
| Physical activity | Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention | 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. |
| Fatigue | Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention | 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. |
| Level of pain | Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention | 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 |
| Quality of well-being | Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention | 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. |
| Change in mindfulness | Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention | 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. |
| Change in exercise motivation | Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention | The Chinese Behavioural Regulation in Exercise Questionnaire-2 includes 18 items across amotivation, external regulation, introjected regulation, identified regulation, and intrinsic regulation. |
Countries
Hong Kong
Contacts
CONTACTHammoda ABU-ODAH, Assistanr Professor
Outcome results
None listed