Metastasis, Prostatic Neoplasms
Conditions
Brief summary
The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question\[s\] it aims to answer are: * What is the impact of exercise on quality of life * What is the impact of exercise on physical fitness Participants will have an individual training program with supervised training by physiotherapists. Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program.
Interventions
OTHERPhysiotherapy
supervised training program for twelve weeks + usual care + advice about exercise
Sponsors
Canisius-Wilhelmina Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
In a single blinded (investigators blinded to group allocation) randomized controlled pilot, conducted in the CWZ, 20 patients with advanced prostate cancer will be randomized across: 1) supervised training program for twelve weeks + usual care + advice about exercise, or 2) usual care + advice about exercise.
Intervention model description
randomized controlled trial with an intervention arm and an usual care group
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Age \> 18 years old * Able to read and complete questionnaires in Dutch * Proven histologically and /or radiologically metastatic prostate cancer (TxNxM1)
Exclusion criteria
* Other cancers * Clinicians' judgement * Age \>80 years old or not able to walk 400m * Structural exercise (moderate-intensity exercise more than 150 minutes a week) during the past 3 months * Musculoskeletal, cardiovascular, or neurological disorders that could inhibit them from exercising * Spinal cord compression, history of pathological fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of quality of life assessed with EPIC26 (0-100 points) | 6 months | To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaire is used: Expanded Prostate Cancer Index Composite (EPIC26). With higher scores representing better disease-related quality of life. |
| change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale) | 6 months | To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A higher score represents a higher response level. So a higher score for the functional scale represents a higher level of physical functioning but a higher score for the symptoms scale represents a higher level of symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of physical fitness in maximum uptake of oxygen in ml/kg/min | 6 months | Assessment of the effectiveness of a supervised training program on cardiopulmonary fitness in patients with metastatic prostate cancer compared to usual care. |
| change of physical fitness in fat percentage | 3 months | change in body composition in patients with metastatic prostate cancer compared to usual care. |
| change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)) | 3 months | To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: Short Hebrew International Physical Activity Questionnaire (IPAQ-sh). Both categorical and continuous indicators of physical activity will be used from the IPAQ short form. There are three categories:1. inactive, 2. minimally active, 3. HEPA active (health enhancing physical activity; a high active category). The continuous score is reported in median MET-minutes (metabolic equivalent of task-minutes). For categorical and continuous score is a higher score equivalent of higher physical functioning. |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORJean-Paul van Basten, Dr. MD
Canisius Wilhelmina Ziekenhuis (CWZ)
Outcome results
None listed