ELIFIT: PCa Patients Managed With ADT to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training
Study Details
Study Description
Brief Summary
The purpose of this observational study is to examine the level of activity in the prostate cancer population treated with Androgen Deprivation Therapy (ADT).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Changes in the patient quality of life (QoL) using the EORTC QLQ-C30 [Month 0 to Month 36]
The EORTC QLQ-C30 is a questionnaire designed to measure quality of life of cancer patient.
- Changes in the patient quality of life (QoL) using the FACT-P [Month 0 to Month 36]
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.
- Changes in the patient quality of life (QoL) using the FACIT Fatigue Scale [Month 0 to Month 36]
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.
Secondary Outcome Measures
- Determine compliance of home-based exercises and regular physical activities [3 Years]
To determine the compliance of home-based exercises and regular physical activities using a weekly activity log.
- Determine the impact of exercise and physician support on activity levels [3 Years]
To determine the impact of exercise and physician support on activity levels using the weekly activity log, home diary or NIKE+ Fuelband.
- Assess the impact of nutritional guidance and exercise with physician support on BMI [3 Years]
To determine if BMI (body mass index) scores decrease with nutritional guidance and exercise with physician support.
- Mobility of prostate cancer patients measured by TUG Test [3 Years]
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)
- Determine the safety and tolerability of ADT in the management of prostate cancer [3 Years]
Safety and tolerability will be assessed based on the number and type of adverse events collected over the study duration.
- # of patients who discontinued prescribed treatment or intermittent usage of prescribed treatment [3 Years]
To determine # of patients who discontinued ADT therapy over the course of the study with reasons describing why.
- Mobility of prostate cancer patients measured by Five Times Sit to Stand Test (FTSST) [3 years]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male patient aged ≥ 18 years old
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Able to read and sign an approved Informed Consent Form (ICF)
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Diagnosed with locally advanced or metastatic prostate cancer
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Patient is treatment naive for ADT or has started ADT (3 or 4 month depot injection) AND has not received more than 1 treatment of 3 or 4 month ADT OR Patient is on intermittent therapy with an ADT agent and will be restarting ADT (3 or 4 month depot injection)
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ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
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Willingness to track weekly physical activities with or without participating in a home based exercise program during the course of this study. The physical activities will be tracked with a weekly activity log or a NIKE+ Fuelband
Exclusion Criteria:
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Currently participating in a clinical study or observational study
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Has a survival expectancy of < 2 years
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Has any other condition that, in the opinion of the treating physician, may affect the patient's health or outcome of the trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southern Interior Medical Research Inc. | Kelowna | British Columbia | Canada | V1W 4V5 |
| 2 | Silverado Research Inc. | Victoria | British Columbia | Canada | V8T 2C1 |
| 3 | Barrie Urology Group | Barrie | Ontario | Canada | L4M 7G1 |
| 4 | Euroscope Inc. | Barrie | Ontario | Canada | L4M 7G1 |
| 5 | Dr. Gregory Leal | Belleville | Ontario | Canada | K8P 3Z9 |
| 6 | Jonathan Giddens Medical Professional Corp. | Brampton | Ontario | Canada | L6T 4S5 |
| 7 | Brantford Urology Research | Brantford | Ontario | Canada | N3S 6T6 |
| 8 | Kenneth Jansz Medical Professional Corp. | Burlington | Ontario | Canada | L7N 3V2 |
| 9 | Stanley Flax Medical Professional Corp. | North York | Ontario | Canada | M2J 1V1 |
| 10 | The Fe/Male Health Centres | Oakville | Ontario | Canada | L6H 3P1 |
| 11 | The Fe/Male Health Centre | Oakville | Ontario | Canada | L6H 3P1 |
| 12 | Kawartha Urology | Peterborough | Ontario | Canada | K9H 1T6 |
| 13 | Urology Clinic | Scarborough | Ontario | Canada | M1S 4V5 |
| 14 | Michael L. Pianezza Medicine Professional Corp. | Sudbury | Ontario | Canada | P3E 4T3 |
| 15 | Northern Urology Centre | Sudbury | Ontario | Canada | P3E 4T3 |
| 16 | Dr. Jonathan Chan Medical Professional Corp. | Toronto | Ontario | Canada | M1V 0E3 |
| 17 | Umesh Jain Medicine Professional Corp. | Toronto | Ontario | Canada | M6S 4W4 |
| 18 | Recherches Cliniques Theradev | Granby | Quebec | Canada | J2G 8Z9 |
| 19 | UroLaval | Laval | Quebec | Canada | H7G 2E6 |
| 20 | Hopital Maisonneuve-Rosemont | Montreal | Quebec | Canada | H1T 2M4 |
| 21 | Ultra-Med Inc. | Pointe-Claire | Quebec | Canada | H9R 4S3 |
| 22 | CHU de Quebec - L'hotel-dieu de Quebec | Quebec City | Quebec | Canada | G1R 2J6 |
| 23 | Centre de Recherche en Urologie de Lanaudiere | St. Charles Borromee | Quebec | Canada | J6E 9H3 |
Sponsors and Collaborators
- CMX Research
- Sanofi
Investigators
- Study Director: Richard Casey, MD, CMX Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMX-SC-2013-001