Prehabilitation in Prostate Cancer Patients, TelePrehabTrial

NCT ID: NCT05608746

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

Group Type EXPERIMENTAL

Physical Exercise

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Nutritional supplement

Intervention Type DIETARY_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.

Stress management

Intervention Type OTHER

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.

Intervention Type OTHER

One week preoperatively the usual regime for the presurgical preparation and information will be followed.

Control Group

Group Type OTHER

Standard pre-surgical preparation and pt. information.

Intervention Type OTHER

One week preoperatively the usual regime for the presurgical preparation and information will be followed.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Standard pre-surgical preparation and pt. information.

One week preoperatively the usual regime for the presurgical preparation and information will be followed.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Gødstrup Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Regional Hospital Goedstrup

Herning, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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PREHABRHG001

Identifier Type: -

Identifier Source: org_study_id

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