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Prostate CancereMindExCareNCT07735273

eMindExCare for Prostate Cancer Patients Undergoing Active Treatment

A study testing eMindExCare and Enhanced Health Education in people with Prostate Cancer and Sleep Disturbance, run by The University of Hong Kong at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Sleep Disturbance, Fatigue
What is being tested?
eMindExCare and Enhanced Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteHong Kong
Study dates
1 Oct 2026to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hammoda ABU-ODAH, Assistanr Professor contact

+85294983446

hammoda@hku.hk

Hong Kong1 site
  • Prince of Wales Hospital, Urology Division

    Hong Kong

    Chi Fai NG, Professor, +85235052625, ngcf@surgery.cuhk.edu.hk

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Being tested
eMindExCare, Enhanced Health Education
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
Medical subject headings
Prostatic Neoplasms, Parasomnias, Fatigue, Sedentary Behavior, Pain, Motor Activity, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eMindExCareBehavioural

    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.

  • Enhanced Health EducationBehavioural

    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.

Study groups in NCT07735273
Study groupRoleWhat they receive
eMindExCareExperimentalParticipants 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.
Receives: Behavioral: eMindExCare
Enhanced Health EducationActive comparatorParticipants 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.
Receives: Behavioral: Enhanced Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment feasibility measured by eligibility rate

    Eligibility rate will be calculated as the number of eligible patients divided by the number of patients screened.

    Measured: Through recruitment completion, up to 3 months

  2. 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.

    Measured: Through recruitment completion, up to 3 months

  3. 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

    Measured: Through recruitment completion, up to 3 months

  4. Intervention attendance rate

    Attendance rate will be calculated as the proportion of scheduled intervention or control sessions attended by each participant.

    Measured: Through completion of the 8-week intervention

  5. 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.

    Measured: Immediately after the 8-week intervention and 3 months after the intervention

  6. 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

    Measured: Baseline, immediately after the 8-week intervention, and 3 months after the intervention

  7. 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.

    Measured: Baseline, immediately after the 8-week intervention, and 3 months after the intervention

Secondary outcomes (8)
  1. 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.

    Measured: Baseline, immediately after the 8-week intervention, and 3 months after the intervention

  2. 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.

    Measured: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention

  3. 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.

    Measured: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention

  4. 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.

    Measured: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention

  5. 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

    Measured: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention

  6. 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.

    Measured: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention

  7. 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.

    Measured: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention

  8. 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.

    Measured: Seven consecutive days at baseline, immediately after the 8-week intervention, and 3 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blind, parallel, two-arm feasibility randomized controlled trial comparing eMindExCare with an enhanced health education attention-control programme.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07735273
Sponsor's protocol ID
23241311
Acronym
eMindExCare
Status last verified
Jan 2026
First submitted
22 Jun 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing eMindExCare and Enhanced Health Education in people with Prostate Cancer and Sleep Disturbance, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hammoda ABU-ODAH, Assistanr Professor (+85294983446, hammoda@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment feasibility measured by eligibility rate (time frame: Through recruitment completion, up to 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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