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Recruiting NCT07162987

Prehabilitation to Patients With Prostate Cancer

No phase Interventional Prostate Cancer (Diagnosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prehabilitation.
Who it may be relevant to
Registry conditions: Prostate Cancer (Diagnosis). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prehabilitation to Patients With Prostate Cancer, Who Are About to Receive Androgen Deprivation Therapy and Radiation Therapy

Overview

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

Interventions

  • Behavioral Prehabilitation
    Please refer to arm description

Primary outcome measures

  • Change from baseline to follow-up in quality of life measured by EORTC-QLQ-C30 [Time frame: From baseline (shortly after enrollment) to 24 and 48 weeks later.]
Secondary outcome measures (7)
  • Change in prostate-cancer related symptoms and problems from baseline to follow-up measured by the EPIC-26 [Time frame: Measured at baseline (shortly after recruitment) and at 24 and 48 weeks.]
  • Change in fatigue from baseline to follow-up using the BFI [Time frame: 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 [Time frame: At baseline (shortly after inclusion) and at 24 and 48 weeks.]
  • Change in depression from baseline to follow-up measured by the PHQ-9 [Time frame: 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 [Time frame: Baseline and at 24 and 48 weeks.]
  • Change in muscle strength from baseline to follow-up measured by 30 sec sit-to-stand test [Time frame: Baseline and after finished exercise training at 12 weeks]
  • Change in function from baseline to follow-up measured by the 6MWT [Time frame: Baseline and after finished exercise training at 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Persons who do not fulfil the inclusion criteria will be excluded

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Denmark · 3 centers
  • Esbjerg Hospital — Esbjerg
  • REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care — Nyborg
  • Vejle Hospital — Vejle

Identifiers

NCT: NCT07162987 · 25/31257

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗