eMindExCare for Prostate Cancer Patients Undergoing Active Treatment | NCT07735273

NCT07735273

Overview

NCT ID: NCT07735273
Lead Sponsor: The University of Hong KongOTHER
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
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: May 30, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Hammoda ABU-ODAH, Assistanr ProfessorContact
hammoda@hku.hk+85294983446

Similar Studies

Participant Group/Arms

eMindExCareExperimental

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 EducationActive 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