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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The purpose of this observational study is to examine the level of activity in the prostate cancer population treated with Androgen Deprivation Therapy (ADT).
The aim of the current observational study will be to examine the level of activity in the prostate cancer population treated with ADT therapy; specifically, the impact of physical activity levels along with nutritional guidance through physician support. The application of an innovative technology to motivate patients will also be examined through the provision of an accelerometer/pedometer (NIKE+ FuelBand). The physical activity will be monitored by a NIKE+ Fuelband or tracked on an activity log.This study will assess the clinical and patient reported outcomes relevant to the management of their prostate cancer, in conjunction with a program assessing daily physical activities and nutritional guidance on the impact on the patient's quality of life, mobility and weight maintenance.
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the patient quality of life (QoL) using the EORTC QLQ-C30 | The EORTC QLQ-C30 is a questionnaire designed to measure quality of life of cancer patient. | Month 0 to Month 36 |
| Changes in the patient quality of life (QoL) using the FACT-P | The FACT-P (Functional Assessment of Cancer Therapy - Prostate) is a questionnaire used to assess the health-related quality of life in men with prostate cancer. | Month 0 to Month 36 |
| Changes in the patient quality of life (QoL) using the FACIT Fatigue Scale | The FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale is a questionnaire that measures an individuals level of fatigue during their usual daily activities over the past week. | Month 0 to Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine compliance of home-based exercises and regular physical activities | To determine the compliance of home-based exercises and regular physical activities using a weekly activity log. | 3 Years |
| Determine the impact of exercise and physician support on activity levels |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that are being treated for prostate cancer with urologists in a community or academic/hospital setting.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Casey, MD | CMX Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Interior Medical Research Inc. | Kelowna | British Columbia | V1W 4V5 | Canada | ||
| Silverado Research Inc. |
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To determine the impact of exercise and physician support on activity levels using the weekly activity log, home diary or NIKE+ Fuelband. |
| 3 Years |
| Assess the impact of nutritional guidance and exercise with physician support on BMI | To determine if BMI (body mass index) scores decrease with nutritional guidance and exercise with physician support. | 3 Years |
| Mobility of prostate cancer patients measured by TUG Test | To assess the impact of nutritional guidance and exercise with physician support on the mobility of prostate cancer patients treated with ADT as measured by the Timed Up and Go Test (TUG) | 3 Years |
| Determine the safety and tolerability of ADT in the management of prostate cancer | Safety and tolerability will be assessed based on the number and type of adverse events collected over the study duration. | 3 Years |
| # of patients who discontinued prescribed treatment or intermittent usage of prescribed treatment | To determine # of patients who discontinued ADT therapy over the course of the study with reasons describing why. | 3 Years |
| Mobility of prostate cancer patients measured by Five Times Sit to Stand Test (FTSST) | To assess the impact of nutritional guidance and exercise with physician support on the mobility of prostate cancer patients treated with ADT as measured by the Five Times Sit to Stand Test (FTSST). | 3 years |
| Victoria |
| British Columbia |
| V8T 2C1 |
| Canada |
| Barrie Urology Group | Barrie | Ontario | L4M 7G1 | Canada |
| Euroscope Inc. | Barrie | Ontario | L4M 7G1 | Canada |
| Dr. Gregory Leal | Belleville | Ontario | K8P 3Z9 | Canada |
| Jonathan Giddens Medical Professional Corp. | Brampton | Ontario | L6T 4S5 | Canada |
| Brantford Urology Research | Brantford | Ontario | N3S 6T6 | Canada |
| Kenneth Jansz Medical Professional Corp. | Burlington | Ontario | L7N 3V2 | Canada |
| Michael L. Pianezza Medicine Professional Corp. | Greater Sudbury | Ontario | P3E 4T3 | Canada |
| Northern Urology Centre | Greater Sudbury | Ontario | P3E 4T3 | Canada |
| Stanley Flax Medical Professional Corp. | North York | Ontario | M2J 1V1 | Canada |
| The Fe/Male Health Centres | Oakville | Ontario | L6H 3P1 | Canada |
| The Fe/Male Health Centre | Oakville | Ontario | L6H 3P1 | Canada |
| Kawartha Urology | Peterborough | Ontario | K9H 1T6 | Canada |
| Urology Clinic | Scarborough Village | Ontario | M1S 4V5 | Canada |
| Dr. Jonathan Chan Medical Professional Corp. | Toronto | Ontario | M1V 0E3 | Canada |
| Umesh Jain Medicine Professional Corp. | Toronto | Ontario | M6S 4W4 | Canada |
| Recherches Cliniques Theradev | Granby | Quebec | J2G 8Z9 | Canada |
| UroLaval | Laval | Quebec | H7G 2E6 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Ultra-Med Inc. | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| CHU de Quebec - L'hotel-dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Centre de Recherche en Urologie de Lanaudiere | Saint-Charles-Borromée | Quebec | J6E 9H3 | Canada |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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