Clinical trial NCT06981026: The Effectiveness of Telemedicine Monitoring Prehabilitation in Prostate Cancer Patients Undergoing Radical Prostatectomy
Official title: The Effectiveness of Telemedicine Monitoring Prehabilitation in Prostate Cancer Patients Undergoing Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostatectomy
Prehabilitation
Telemedicine
Keywords: Prostatectomy
Physiotherapy
Telemedicine
eHealth
Oncology
Prehabilitation
Rehabilitation
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: Mobilní fyzioterapie s.r.o.
First posted: 2025-05-20
Enrollment: 200
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study titled " The effectiveness of telemedicine monitoring prehabilitation in prostate cancer patients undergoing radical prostatectomy " investigates the impact of a structured telemedicine-supported prehabilitation and rehabilitation program on reducing postoperative urinary incontinence in patients with localized prostate cancer. Radical prostatectomy, a common treatment for localized prostate cancer, is often associated with complications such as urinary incontinence, which significantly affects quality of life. This study aims to address this issue by enhancing patients' physical conditioning and adherence to pre- and postoperative rehabilitation through the use of wearable devices and remote physiotherapy consultations.

Detailed description: Participants in the intervention group will receive a comprehensive prehabilitation program starting 30 -14 days before surgery. They will be equipped with wearable devices (smartwatch and tablet/mobile phone) to monitor physical activity, including parameters like step count and heart rate, allowing for tailored exercise regimens focused on specific daily activity goals. These participants will also have access to educational videos and online consultations with physiotherapists for ongoing support. The program is designed to optimize physical readiness for surgery and improve postoperative recovery outcomes, with continuous monitoring and notifications provided to encourage adherence to the prescribed activities. The control group will receive printed educational materials with general preoperative exercise guidance. This group will have digital monitoring of physical activity, but patients will not receive any reminders or prompts to complete their exercises, they will not have access to online consultations. The primary endpoint of the study is the reduction of urinary incontinence as measured by the 24-hour pad test at 30 days before the surgery and 6 weeks, 3 and 6 months post-surgery. Secondary endpoints include assessments of physical fitness, quality of life, respiratory and postural function, and adherence to the rehabilitation protocol. Both groups will follow structured postoperative follow-ups with physiotherapists at defined intervals to monitor recovery progress and adjust the rehabilitation protocol as necessary. The study spans approximately 6 months for each participant, aiming to generate critical insights into the benefits of telemedicine in enhancing surgical recovery and improving patient outcomes in prostate cancer treatment.

Eligibility criteria: Inclusion criteria:

* Biopsy-confirmed localized prostate cancer (ICD code C.61).
* Indicated for radical prostatectomy, with or without pelvic lymphadenectomy (ePLND).
* Not previously treated for prostate cancer, including radiation therapy to the pelvis, major pelvic surgery, or placement of a penile implant or artificial urinary sphincter.
* No known urethral stricture or colostomy or chronic urinary catheterization.
* No medical or current psychiatric disorders that precludes their participation in the study.
* Status of the musculoskeletal system allowing physical exercise.
* Urinary continent at baseline.
* Has reliable internet and the skills/knowledge to use technologies use for the study.

Exclusion criteria:

* Other malignant tumors, except for benign skin carcinoma.
* Active treatment for other oncological diagnoses.
* Presence of preoperative urinary incontinence.
* Diagnosed mental or cognitive disorders.
* Prior pelvic radiotherapy or hormone therapy for prostate cancer recurrence.
* Severe musculoskeletal disorders preventing active exercise
* Inability to use required technologies

Primary outcomes:
measure: Reduction in Early Postoperative Incontinence
timeFrame: Baseline evaluated at 30 days before surgery. Evaluated at 6 weeks, 3 months, and 6 months post-surgery.
measure: Time to full Continence Recovery
timeFrame: 3 - 6 months post-surgery
measure: Six-Minute Walk Test Distance
timeFrame: 2 weeks pre-surgery, 3 months and 6 months post-surgery
measure: Balance Test Composite Score
timeFrame: 2 weeks pre-surgery, 3 months and 6 months post-surgery
measure: Lower Limb and abdominal Muscle Strength (Isometric)
timeFrame: 2 weeks pre-surgery, 3 months and 6 months post-surgery
Secondary outcomes:
measure: EPIC-CP Total Score
timeFrame: Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery
measure: EQ-5D-5L Index Score
timeFrame: Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery
measure: Forced Expiratory Volume in One Second (FEV1)
timeFrame: 2 weeks pre-surgery, 3 and 6 months pos-surgery
measure: Maximal Voluntary Ventilation (MVV)
timeFrame: 2 weeks pre-surgery, 3 months post-surgery, and 6 months post-surgery
measure: Daily Step Count
timeFrame: 2 weeks pre-surgery, 3 months and 6 months post-surgery
measure: Daily Physical Activity Duration
timeFrame: 2 weeks pre-surgery, 3 and 6 months post-surgery
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Urology clinic, University hospital Olomouc
Study officials:
References: