eMindExCare for Prostate Cancer Patients Undergoing Active Treatment

NCT07735273 | Not Yet Recruiting

• 1 other identifier: 23241311
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Sleep Disturbance; Fatigue; Physical Inactivity; Pain

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

Outcome Measures

Primary Outcomes (7)

• Recruitment feasibility measured by eligibility rate

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

  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.

  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

  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.

  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.

  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

  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.

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

Secondary Outcomes (8)

• 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

Other Outcomes (1)

• Participant experiences and perceptions of the intervention

  Immediately after the 8-week intervention

Study Arms (2)

eMindExCare

EXPERIMENTAL

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

Enhanced Health Education

ACTIVE COMPARATOR

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

Interventions

eMindExCare BEHAVIORAL

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.

eMindExCare

Enhanced Health Education BEHAVIORAL

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.

Enhanced Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Prince of Wales Hospital, Urology Division

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Parasomnias; Fatigue; Sedentary Behavior; Pain; Motor Activity; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Neurologic Manifestations; Sleep Disorders, Intrinsic; Dyssomnias

Central Study Contacts

Hammoda ABU-ODAH, Assistanr Professor

CONTACT

+85294983446; hammoda@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind, parallel, two-arm feasibility randomized controlled trial comparing eMindExCare with an enhanced health education attention-control programme.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

HK (1)