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| Name | Class |
|---|---|
| REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care | OTHER |
| Vejle Hospital | OTHER |
| Esbjerg Municipality | OTHER_GOV |
| Esbjerg Hospital - University Hospital of Southern Denmark |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Behavioral | Please refer to arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Esbjerg Hospital | Recruiting | Esbjerg | Region Syddanmark | 6700 | Denmark |
A de-identified copy of data may be made available to external researchers upon reasonable request.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| OTHER |
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| 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. | 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. | 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. | 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. | 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. | 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. | Baseline and after finished exercise training at 12 weeks |
| REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care | Recruiting | Nyborg | Region Syddanmark | 5800 | Denmark |
|
| Vejle Hospital | Recruiting | Vejle | Region Syddanmark | 7100 | Denmark |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |