Prehabilitation in Prostate Cancer Patients, TelePrehabTrial
- Conditions
- Prostate Cancer
- Interventions
- Other: Physical ExerciseOther: Pelvic Floor exerciseOther: Sexual counselingDietary Supplement: Nutritional supplementOther: Stress managementOther: Standard pre-surgical preparation and pt. information.
- Registration Number
- NCT05608746
- Lead Sponsor
- University of Aarhus
- Brief Summary
Localized prostate cancer is commonly treated with radical prostatectomy (RP). Following surgery adverse effects such as urinary incontinence, erectile dysfunction associated with decreased quality of life and decreased physical function are common.
Traditionally, interventions to reduce these adverse effects are introduced postoperatively. However, a growing body of literature shows the benefit of interventions prior to surgery to enhance treatment success, known as prehabilitation.
Hence, the main purpose of this study is to develop and investigate the feasibility of prehabilitation using telehealth, to implement several interventions prior to elective RP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 40
- Male > 18 years
- Diagnosed with prostate cancer and referred to robot assisted nerve sparring RP
- Adequacy in written and spoken Danish
- Cognitively well-functioning
- Able to understand the study procedures and willing to provide signed informed consent
- Severe comorbidities that would prevent the patient from exercising, e.g. recent fractures, severe heart disease or neurological disorders.
- No possibility to use a smartphone or tablet.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Physical Exercise - Intervention Group Stress management - Intervention Group Pelvic Floor exercise - Intervention Group Sexual counseling - Intervention Group Nutritional supplement - Intervention Group Standard pre-surgical preparation and pt. information. - Control Group Standard pre-surgical preparation and pt. information. -
- Primary Outcome Measures
Name Time Method Recruitment rate 12 months Percentage of eligible patients who accepted to participate in the study. Recruitment rate is measured by dividing the number of patients consented by the number of patients screened.
Protocol adherence, assessed by study-specific questionnaire 12 months The pt. will every week register his adherence to the intervention protocol. The number of intervention components which were not fulfilled during the prehabilitation period will be counted, and the percentage of deviation will be calculated compared to the total number of intervention components.
Number of participants who received the nutritional and mental health intervention. 12 months Total number of participants who after the initial screening, needed the Nutritional and Mental Health intervention.
Retention rate 12 months Percentage of participants completing the full prehabilitation period, and full follow-up after the surgery. Retention rate is measured by dividing the number of patients completing the study with the number of patients consented.
- Secondary Outcome Measures
Name Time Method Grip strength test 12 months Grip strength is a measure of muscular strength or the maximum force/tension generated by the forearm muscles.
Self-reported physical activity 12 months A questionnaire measuring physical activity consisting of three questions designed by The Swedish National Board of Health and Welfare (BHW).
Hospital Anxiety and Depression Scale (HADS) 12 months Hospital Anxiety and Depression Scale is a questionnaire used to identify anxiety disorders and depression among patients in nonpsychiatric hospital clinics. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.
5-Item International Index of Erectile Function (IIEF-5) 12 months IIEF-5 is an abridged five-item version of the International Index of Erectile Function. It is a self-administered, multi-dimensional measure of erectile function.
Nutritional Risk Screening At baseline (4 weeks before the surgery). NRS-2002 is a validated tool for nutritional screening of patients between 18 and 90 years of age.
6-minute-walk-test (6MWT) 12 months The 6MWT is a performance-based sub-maximal exercise test, used to assess aerobic capacity and endurance. The test covers the distance a person can walk on a 30-meters walkway, in the time of 6 minutes.
30 seconds sit-to-stand test (30STS) 12 months 30STS test is used to assess the leg strength and endurance. The test discovers how many times a person is able to rise up and sit down from a chair within 30 seconds.
24-hour Pad Weigh Test 6, 24 and 50 weeks post surgery. The 24-hour Pad Weigh Test is used to investigate urinary incontinence.
12-Item short form Health Survey (SF-12) 12 months The SF-12 is a short form of the 36-Item Short-form Health Survey (SF-36). It contains 12 items, and is a patient-reported survey of the patient's perception of health related quality of life, during the last 4 weeks.
Trial Locations
- Locations (1)
Regional Hospital Goedstrup
🇩🇰Herning, Denmark