Prehabilitation in Prostate Cancer Patients, TelePrehabTrial

Prostate Cancer Clinical Trial

Official title:

Prehabilitation in Prostate Cancer Patients Undergoing Nerve Sparring Robot Assisted Radical Prostatectomy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608746
• Other study ID #: PREHABRHG001
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: Malene Blumenau Pedersen, Phd student
• Phone: +45 78430568
• Email: malblu[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Physical Exercise
Home-based individualized training, consisting of unsupervised aerobic exercise and resistance exercise, with moderate intensity. The pt. receives an exercise manual and exercise videos online, through an APP.
• Pelvic Floor exercise
Patients will be assessed by a physiotherapist and instructed in a pelvic floor exercise program, accessed through the APP. Furthermore, the pt. is provided with general information about pelvic floor anatomy and muscle function.
• Sexual counseling
Patients will be provided with 1 video-consultation with a clinical sexologist, during the prehabilitation period. The patients will be instructed in strategies to improve postoperative communication regarding, sex, realistic expectations, erectile dysfunction and the use of aids.

Dietary Supplement:
• Nutritional supplement
Patients are systematically screened for malnutrition to assess the nutritional status. Patients are given recommendations with dietary advice online, through the APP. If the patient is at nutritional risk, the patient is provided with a nutritional supplement.

Other:
• Stress management
Patients are systematically screened for anxiety and depression. If patients are at risk of anxiety or depression, they are referred to a consultation with a nurse, who will provide information and strategies to handle the uncertainties they may experience.
• Standard pre-surgical preparation and pt. information.
One week preoperatively the usual regime for the presurgical preparation and information will be followed.

Locations

Country	Name	City	State
Denmark	Regional Hospital Goedstrup	Herning

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University, Institute of Clinical Medicine, Gødstrup Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	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.	24 months
Primary	Protocol adherence, assessed by study-specific questionnaire	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.	24 months
Primary	Number of participants who received the nutritional and mental health intervention.	Total number of participants who after the initial screening, needed the Nutritional and Mental Health intervention.	24 months
Primary	Retention rate	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.	24 months
Secondary	6-minute-walk-test (6MWT)	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.	12 months
Secondary	30 seconds sit-to-stand test (30STS)	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.	12 months
Secondary	Grip strength test	Grip strength is a measure of muscular strength or the maximum force/tension generated by the forearm muscles.	12 months
Secondary	Self-reported physical activity	A questionnaire measuring physical activity consisting of three questions designed by The Swedish National Board of Health and Welfare (BHW).	12 months
Secondary	Hospital Anxiety and Depression Scale (HADS)	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.	12 months
Secondary	12-Item short form Health Survey (SF-12)	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.	12 months
Secondary	5-Item International Index of Erectile Function (IIEF-5)	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.	12 months
Secondary	24-hour Pad Weigh Test	The 24-hour Pad Weigh Test is used to investigate urinary incontinence.	6, 24 and 50 weeks post surgery.
Secondary	Nutritional Risk Screening	NRS-2002 is a validated tool for nutritional screening of patients between 18 and 90 years of age.	At baseline (4 weeks before the surgery).