eMindExCare for Prostate Cancer Patients Undergoing Active Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorThe University of Hong Kong
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
eMindExCare
BehavioralAn 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 Education
BehavioralA 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: eMindExCareExperimental treatment 1 intervention
Group B: Enhanced Health EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Through recruitment completion, up to 3 months2
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 months3
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 months4
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 interventionSecondary outcomes
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.
Time frame
Baseline, immediately after the 8-week intervention, and 3 months after the intervention2
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 intervention3
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 intervention4
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 interventionOther outcomes
1
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Chinese University of Hong Kong
Collaborator
Source ClinicalTrials.gov
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