C61
Conditions
Interventions
Group 1: Control group
no prehabilitation measures during the intervention phase (i.e., standard preparation for prostatectomy) and wearing of the fitness watch
Group 2: Whole-body fitness training as a prehabilitation meas
Sponsors
Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients who meet the following criteria may be included in the study: • Patients are between = 18 and = 85 years of age. • The patient has histologically confirmed prostate carcinoma. • The indication for radical prostatectomy is present and the patient wishes to undergo this procedure. • The patient is physically fit to participate in the planned procedures at the discretion of the investigator. • At the discretion of the investigator, the patient is mentally capable of understanding the consequences of participation in the study and can adequately evaluate the resulting obligations. • The patient gives written documented consent to study participation and the written documented informed consent form is available. • The patient is able to follow the study instructions and is likely to attend all required study visits (compliance). • The patient has the physical and cognitive ability to perform the physical training and participate in the psycho-oncology sessions, at the discretion of the investigator • The patient has the physical and cognitive ability to handle digital media and play internet videos, e.g., for whole body fitness training. • The patient has internet access and appropriate hardware to participate in the whole-body fitness training or to ensure transmission of data from the fitness watch vívosmart® 4 (by Garmin).
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be included in the study: • The patient has a BMI > 40. • The patient is concurrently participating in another clinical trial or has participated in a clinical trial within the last 30 days that involved the use of an investigational drug. • The patient is or has been, to the knowledge or at the discretion of the investigator, dependent on medication, drugs, or alcohol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is represented by multi-item scale "urinary symptoms/ micturition symptoms", of the EORTC QLQ-PR25 questionnaire (to assess quality of life in prostate cancer). The primary endpoint will be assessed at the beginning at visit 1 and at follow-up visits 4-6 and will be compared to visit 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are represented by (sum) scores, which are collected by the following PROM questionnaires: • Continence: sum score of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF) indicating in which situation urine loss occurs, sum of the International Prostate Symptom Score (IPSS), domain incontinence aid of the EORTC QLQ-PR 25, domain incontinence of the EORTC QLQ-SH 22. • Potency/erectile function: sum of the International Index of Erectile Function (IIEF-5), the sexual activity and sexual function domains of the EORTC QLQ-PR 25. • Sexual health: functional domains sexual activity and sexual function of the EORTC QLQ-PR25, domain scores sexual activity, decreased libido, fatigue, communication with professionals, partnership, erection awareness, body image, sexual satisfaction, and sexual pain of the EORTC QLQ-SH 22 • Mental health: sum score of the Patient Health Questionnaire-9 (PHQ-9). • Performance/functional capacity: sum score and metabolic equivalents of the Duke Activity Status Index (DASI). • Quality of life: symptom domain "symptoms related to hormone therapy" of the EORTC QLQ PR 25 and from the EORTC QLQ C30 the functional domains physical function, role function, emotional function, cognitive function, social function, the symptom domains, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, loss of appetite, constipation, diarrhoea, financial difficulties, and the Global health status/quality of life domain. • Gastrointestinal Symptoms: Bowel Symptoms domain of the EORTC QLQ-PR 25. The secondary endpoints will be assessed at the beginning at visit 1 and at follow-up visits 4-6 and will be compared to visit 1. Tertiary endpoints include: • Patients' assessment of study participation and prehabilitation intervention (e.g., subjective added value, relevant limitation of daily routine). (The assessment is carried out on visit 6). • the drop-out rate in individual intervention groups (The as | — |
Countries
Germany
Contacts
Public ContactMarina Bertlich
Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn
Outcome results
None listed