The Effectiveness of Telemedicine Monitoring Prehabilitation in Prostate Cancer Patients Undergoing Radical Prostatectomy

University Hospital Olomouc

Status: Not yet enrolling

Conditions: Prostatectomy; Telemedicine; Prehabilitation

Treatments: Other: Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools.

Study type: Interventional

Funder types: Other

Identifiers

NCT06981026

CZ.02.01.01/00/23_021/0008829 (Other Grant/Funding Number)

OP JAK ITI VZ 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

Telemedicine-Supported Prehabilitation and Rehabilitation

Experimental group

Description:

Preoperative Phase: Wearable Technology: Smartwatch monitoring steps, heart rate, and activity. Physical Exam \& Physiotherapy Session: Musculoskeletal evaluation, pelvic floor training via sonographic feedback, posture/respiratory exercises (2-4 weeks pre-surgery). Activity Guidelines: Specific daily step targets and exercises to optimize surgical readiness. Educational Support: Videos demonstrating pelvic floor training, posture, breathing, and exercises. Remote Monitoring \& Notifications: Continuous monitoring with inactivity alerts/reminders. Online Consultations: Virtual physiotherapy sessions for feedback and plan adjustments. Postoperative Phase: Physiotherapy Visits: At 3, 4, 6 weeks; 3, 6 months post-surgery for assessment and rehab adjustments. Telemonitoring: Continued wearable monitoring, video consultations, and access to educational videos. Data Collection: Objective wearable data collected to track progress, adherence, and personalize rehab.

Treatment:

Other: Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools.

Control Group (Standard Preoperative and Postoperative Care)

No Intervention group

Description:

Preoperative Phase: Wearable Technology: Participants receive wearable devices (smartwatch, tablet or phone) for real-time monitoring of physical activity parameters (step count, heart rate, general activity). Physical Exam \& Physiotherapy: Physiotherapist evaluates musculoskeletal function, provides verbal education on pelvic floor muscle activity, posture, and respiratory exercises; scheduled 2-4 weeks pre-surgery. Printed Educational Material: Participants receive printed booklets containing general information, exercises, and activity guidelines to prepare for surgery. Telemonitoring (No Notifications): Activity digitally monitored, without sending reminders or prompts for exercise adherence. Postoperative Phase: Physiotherapy Visits: Scheduled at 3 weeks, 4 weeks, 6 weeks, 3 months, and 6 months post-surgery for progress assessment and rehabilitation adjustments. Data Collection: Continuous collection of objective data from wearable devices compared to intervention group.