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lagging inclusions
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | supervised training program for twelve weeks + usual care + advice about exercise |
|
| usual care | No Intervention | usual care + advice about exercise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiotherapy | Other | supervised training program for twelve weeks + usual care + advice about exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of quality of life assessed with EPIC26 (0-100 points) | 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. | 6 months |
| change of quality of life assessed with EPIC26 (0-100 points) | 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. | 3 months |
| change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale) | 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. | 6 months |
| change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| change of physical fitness in maximum uptake of oxygen in ml/kg/min | Assessment of the effectiveness of a supervised training program on cardiopulmonary fitness in patients with metastatic prostate cancer compared to usual care. | 6 months |
| change of physical fitness in maximum uptake of oxygen in ml/kg/min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul van Basten, Dr. MD | Canisius-Wilhelmina Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canisius Wilhelmina Ziekenhuis (CWZ) | Nijmegen | Gelderland | 6532SZ | Netherlands |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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randomized controlled trial with an intervention arm and an usual care group
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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.
| 3 months |
Assessment of the effectiveness of a supervised training program on cardiopulmonary fitness and body composition in patients with metastatic prostate cancer compared to usual care. |
| 3 months |
| change of physical fitness in fat percentage | change in body composition in patients with metastatic prostate cancer compared to usual care. | 3 months |
| change of physical fitness in fat percentage | change in body composition in patients with metastatic prostate cancer compared to usual care. | 6 months |
| change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)) | 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. | 3 months |
| change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)) | 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. | 6 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |