Prehabilitation in Prostate Cancer Patients, TelePrehabTrial

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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