Prehabilitation to Patients With Prostate Cancer

Odense University Hospital20 enrolled

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Prostate Cancer (Diagnosis)

Interventions

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

As with the primary outcome measure, the purpose in this pilot study is mainly to test the feasibility of the chosen secondary outcome measures. One of the secondary outcomes is prostate cancer related quality of life, measured by five domains in the Expanded Prostate Cancer Index Composite (EPIC-26): urinary incontinence (four items), urinary irritation/obstruction (four items), bowel (six items), sexual (six items) and vitality/hormonal function (five items) and a single-item measure of overall urinary bother. The aim is for the scores in these domains to remain stable from baseline to follow-up at 24 and 48 weeks.

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

Measured by the Brief Fatigue Inventory (BFI), the aim is stable levels of fatigue from baseline to follow-up at 24 and 48 weeks.

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

As with all other measures tested in this one-armed pilot study, the main aim is to test the feasibility of the chosen outcome measures. We aim to measure change in anxiety from baseline to follow-up at 24 and 48 weeks measured by the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire. The target is unchanged anxiety.

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

We aim to measure depression severity using the Patient Health Questionnaire-9 (PHQ-9). The target is unchanged depression score from baseline to follow-up.

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

Change in body mass index (BMI) can be calculated after retrieving the patients' weight and height. Height in meters will be collected at baseline by self-report (through a patient questionnaire). Weight in kilograms will be collected at baseline and follow-up also by self-report. Weight and height will hereafter be combined to report BMI in kg/m\^2. The target is no change in BMI from baseline to follow-up.

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

Lower limb muscle strength is measured by the 30 seconds sit-to-stand test. The target is unchanged muscle strength from baseline to follow-up.

Time frame: Baseline and after finished exercise training at 12 weeks

Change in function from baseline to follow-up measured by the 6MWT

Functional exercise capacity is measured by the 6-minute walk test (6MWT). The target is no change in functional exercise capacity from baseline to follow-up.