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Trial Title:
Prehabilitation in Prostate Cancer Patients, TelePrehabTrial
NCT ID:
NCT05608746
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Physical Exercise
Description:
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.
Arm group label:
Intervention Group
Intervention type:
Other
Intervention name:
Pelvic Floor exercise
Description:
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.
Arm group label:
Intervention Group
Intervention type:
Other
Intervention name:
Sexual counseling
Description:
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.
Arm group label:
Intervention Group
Intervention type:
Dietary Supplement
Intervention name:
Nutritional supplement
Description:
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.
Arm group label:
Intervention Group
Intervention type:
Other
Intervention name:
Stress management
Description:
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.
Arm group label:
Intervention Group
Intervention type:
Other
Intervention name:
Standard pre-surgical preparation and pt. information.
Description:
One week preoperatively the usual regime for the presurgical preparation and information
will be followed.
Arm group label:
Control Group
Arm group label:
Intervention Group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Regional Hospital Goedstrup
Address:
City:
Herning
Zip:
7400
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Malene B. Pedersen
Start date:
November 8, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
University of Aarhus
Agency class:
Other
Collaborator:
Agency:
Gødstrup Hospital
Agency class:
Other
Collaborator:
Agency:
Aarhus University, Institute of Clinical Medicine
Agency class:
Other
Source:
University of Aarhus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05608746
