Prehabilitation in Prostate Cancer Patients, TelePrehabTrial

NCT05608746 | Active Not Recruiting

• 1 other identifier: PREHABRHG001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  12 months

• 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.

  12 months

• 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.

  12 months

• 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.

  12 months

Secondary Outcomes (9)

• 6-minute-walk-test (6MWT)

  12 months

• 30 seconds sit-to-stand test (30STS)

  12 months

• Grip strength test

  12 months

• Self-reported physical activity

  12 months

• Hospital Anxiety and Depression Scale (HADS)

  12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Other: Physical Exercise; Other: Pelvic Floor exercise; Other: Sexual counseling; Dietary Supplement: Nutritional supplement; Other: Stress management; Other: Standard pre-surgical preparation and pt. information.

Control Group

OTHER

Other: Standard pre-surgical preparation and pt. information.

Interventions

Physical Exercise 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.

Intervention Group

Pelvic Floor exercise 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.

Intervention Group

Sexual counseling 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.

Intervention Group

Nutritional supplement 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.

Intervention Group

Stress management 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.

Intervention Group

Standard pre-surgical preparation and pt. information. OTHER

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

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Gødstrup Hospital: collaborator

Study Sites (1)

Regional Hospital Goedstrup

Herning, 7400, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Exercise; Sex Counseling; Dietary Supplements

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sexology; Behavioral Sciences; Behavioral Disciplines and Activities; Counseling; Mental Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 8, 2022
• Study Start: November 8, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)