Prehabilitation to Patients With Prostate Cancer

NCT07162987 | Recruiting

• 1 other identifier: 25/31257
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this feasibility study is to test a newly developed, multicomponent prehabilitation intervention to patients with prostate cancer, to improve their resilience to treatment side-effects. The main questions it aims to answer are:

• Are patients and their close relatives willing to take part in prehabilitation?
• What is the acceptability and feasibility of the prehabilitation intervention, seen from the perspectives of patients, their close relatives, and healthcare professionals?
• Are the planned data collection methods feasible, and are there indications of a clinical effect? Participants will:
• Take part in 12 weeks of physical exercise training
• Attend a 4-day residential prehabilitation intervention, where they receive education and do exercises. After 12 weeks, it is possible to take part in a voluntary follow-up session.
• Patients will respond to questionnaires about their health, symptoms, and quality of life. Patients and their close relatives will attend a group interview. Patients will also complete an exercise diary and brief physical tests

Conditions

Prostate Cancer (Diagnosis)

Keywords

prostate cancer; prehabilitation; androgen deprivation therapy; radiation therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline to follow-up in quality of life measured by EORTC-QLQ-C30

  This is a pilot study with one arm only, thus the aim is mainly to test the feasibility of the chosen primary outcome measure, including whether there are tendencies in data that support the aim of participants maintaining stable quality of life. Hence, measured by the European Organization for the Research and Treatment of Cancer Qality of life Questionnaire (EORTC QLQ-C30), the target is unchanged (stable) quality of life measured from baseline to follow-up at 24 and 48 weeks.

  From baseline (shortly after enrollment) to 24 and 48 weeks later.

Secondary Outcomes (7)

• Change in prostate-cancer related symptoms and problems from baseline to follow-up measured by the EPIC-26

  Measured at baseline (shortly after recruitment) and at 24 and 48 weeks.

• Change in fatigue from baseline to follow-up using the BFI

  Measured at baseline (shortly after inclusion) and at 24 and 48 weeks.

• Change in anxiety from baseline to follow up measured by the GAD-7

  At baseline (shortly after inclusion) and at 24 and 48 weeks.

• Change in depression from baseline to follow-up measured by the PHQ-9

  Measured at baseline (shortly after inclusion) and at 24 and 48 weeks

• Change in BMI from baseline to follow-up calculated from self-reported height and weight

  Baseline and at 24 and 48 weeks.

Study Arms (1)

Patients receiving prehabilitation

EXPERIMENTAL

The prehabilitation intervention includes: - Education about the disease and treatment - Physical exsercise training - Values in life - Energy preservation - Nutrition with a focus on hormone therapy - Identiy and role changes - Intimacy and sexuality - Sleep - Pelvic floor training - An individual session with a healthcare professional incl. goal setting

Behavioral: Prehabilitation

Interventions

Prehabilitation BEHAVIORAL

Please refer to arm description

Patients receiving prehabilitation

Eligibility Criteria

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

You may qualify if:

• Diagnosed with prostate cancer
• min 18 years old
• Treatment: Androgen deprivation therapy and raditation therapy
• Resident in Vejle Municipality or Esbjerg Municipality
• Can take part in residential prehabiliation in week 43 or 50, 2025, as well as physical exsercise training in the municipality
• Willing to take part in a research study
• Suited to take part in group sessions
• Be able to read and be understood in Danish
• Be responsible for own personal hygiene and medications at the 4-day residential stay

Sponsors & Collaborators

• Odense University Hospital: lead
• REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care: collaborator
• Vejle Hospital: collaborator
• Esbjerg Municipality: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator

Study Sites (3)

Esbjerg Hospital

Esbjerg, Region Syddanmark, 6700, Denmark

RECRUITING

REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care

Nyborg, Region Syddanmark, 5800, Denmark

RECRUITING

Vejle Hospital

Vejle, Region Syddanmark, 7100, Denmark

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: September 9, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

DK (3)