CRONOS II: Evaluation of Diet and Exercise in Prostate Cancer Patients
Study Details
Study Description
Brief Summary
Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed with Lupron.
Condition or Disease | Intervention/Treatment | Phase |
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|
Detailed Description
This is a study utilizing a prospective cohort design. Patients with Prostrate cancer (PCa) who are prescribed Lupron will be entered into the study cohort and will be followed for a maximum of 18 months with recommended assessments at 3, 6, 12 and 18 months after Day 1. Treatment of the patients and follow up will be according to the physicians' judgment, regional regulations and the product monograph.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Prostate Cancer Patients Prostate Cancer Patients |
Outcome Measures
Primary Outcome Measures
- Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36) [From Month 0 to Month 18]
The SF-36 Health is a 36-item general health self-administered questionnaire consisting of 8 scales measuring Physical Function, Physical Role limitations, Vitality, General Health, Pain, Social Function, Emotional Role limitations, and Mental Health.
- Change in exercise duration [From Month 0 to Month 18]
Assessed at every visit what was the amount of various types of exercise performed in the previous month.
- Change in dietary habits [From Month 0 to Month 18]
Assessed at every visit to what extent patient's complied with the Canadian Food Guide's recommendation for each of the four food group servings in the previous week.
Secondary Outcome Measures
- Change in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36) [From Month 0 to follow-up visits 3,6 and 12 months]
The SF-36 Health is a 36-item general health self-administered questionnaire consisting of 8 scales measuring Physical Function, Physical Role limitations, Vitality, General Health, Pain, Social Function, Emotional Role limitations, and Mental Health.
- Change in weight [From Month 0 to Month 18]
Change from Baseline is calculated as the post-Baseline value minus the Baseline value.
- Change in Body Mass Index (BMI) [From Month 0 to Month 18]
BMI is a measure of body fat based on weight in relation to height. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.
- Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI) [From Month 0 to Month 18]
A validated questionnaire designed to measure quality of life in patients with prostate cancer. It consists of 20 questions that assess urinary, sexual, bowel and hormonal function and impairment in patients with prostate cancer.
- Changes in the sexual function using the International Index of Erectile Function (IIEF-5) [From Month 0 to Month 18]
An abridged 5 item self-administered questionnaire assessing the presence and severity of erectile dysfunction (for patients enrolled prior to protocol amendment 2)
- Number of patients with Adverse Events [From Month 0 to Month 18]
Adverse events which lead to discontinuation of prescribed treatment under observation, will be coded according to the Medical Dictionary for Regulatory Activities (MeDRA) dictionary of terms
- Changes in the patient's medical condition [From Month 0 to Month 18]
Any change in the patient's medical condition including new onset or worsening of medical conditions.
- Proportion of patients with castrate levels of testosterone and undetectable levels of Prostatic Specific Antigen (PSA) at 18 months of treatments. [From Month 0 to Month 18]
The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. A testosterone test checks the level of this male hormone (androgen) in the blood.
- Leuprolide Acetate Utilization [From Month 0 to Month 18]
Utilization of Leuprolide Acetate will be assessed.
- Changes in the Doctor-Patient communication (for patients enrolled prior to protocol amendment 2) [From Month 0 to Month 18]
This will be ascertained with the Doctor-Patient Communication/Doctor's Questionnaire and the Doctor-Patient Communication/Patient's Questionnaire that are validated questionnaires developed by the College of Physicians of Quebec
- Caregiver Quality of Life (for patients enrolled under protocol amendment 1) [From Month 0 to Month 18]
Measured with the Caregiver Quality of Life Index - Cancer scale (CQOLC). This is a 35 item questionnaire that measures the quality of life of individuals caring for cancer patients.
- Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1) [Up to Month 18]
Measured with a self-reported questionnaire.
- Lupron Cares Patient Support Program [Up to Month 18]
Enrollment and use will be assessed for the patient support program.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult ≥ 18 years old
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Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.
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Diagnosed with PCa.
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Prescribed Lupron as part of his treatment by his treating physician.
Exclusion Criteria:
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Patient cannot or will not sign informed consent.
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Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of PCa.
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More than 6 months of therapy if currently on continuous Luteinizing hormone-releasing hormone (LHRH) treatment.
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If at study enrollment the intent is to only prescribe 1 dose of Lupron (leuprolide acetate)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Exdeo Clinical Research Inc /ID# 116040 | Abbotsford | British Columbia | Canada | V2T 1X8 |
2 | Southern Interior Medical Research /ID# 116025 | Kelowna | British Columbia | Canada | V1W 4V5 |
3 | Dr. J. Paul Whelan, Inc. /ID# 120415 | Victoria | British Columbia | Canada | V8V 3N1 |
4 | CancerCare Manitoba /ID# 135976 | Winnipeg | Manitoba | Canada | R3E 0V9 |
5 | Saint John Regional Hospital /ID# 141302 | Saint John | New Brunswick | Canada | E2L 4L2 |
6 | QE II Health Sciences Centre /ID# 118941 | Halifax | Nova Scotia | Canada | B3H 1V7 |
7 | The Male/Female Hlth and Res /ID# 116042 | Barrie | Ontario | Canada | L4M 7G1 |
8 | The Male/Female Hlth and Res /ID# 124295 | Barrie | Ontario | Canada | L4M 7G1 |
9 | Edward F.A. Woods Medicine Professional Corporation /ID# 120695 | Belleville | Ontario | Canada | K8P 3Z9 |
10 | Jonathan Giddens Medicine /ID# 116023 | Brampton | Ontario | Canada | L6T 4S5 |
11 | Brantford Urology Research /ID# 116026 | Brantford | Ontario | Canada | N3S 6T6 |
12 | G. Kenneth Jansz Medicine Professional Corporation /ID# 116024 | Burlington | Ontario | Canada | L7N 3V2 |
13 | William R. Love, Medicine, Professional Corporation /ID# 116035 | Burlington | Ontario | Canada | L7S 1V2 |
14 | St. Joseph's Healthcare /ID# 163973 | Hamilton | Ontario | Canada | L8N 4A6 |
15 | Queen's University /ID# 137983 | Kingston | Ontario | Canada | K7L 3J7 |
16 | London Health Sciences Center /ID# 118940 | London | Ontario | Canada | N6A 5W9 |
17 | DiCostanzo, Markham, CA /ID# 137272 | Markham | Ontario | Canada | L6B 0T1 |
18 | Mor Urology Inc /ID# 116027 | Newmarket | Ontario | Canada | L3X 1W1 |
19 | Stanley Flax Medical Prof Corp /ID# 116022 | North York | Ontario | Canada | M2J 1V1 |
20 | Fe/Male Health Centers /ID# 116020 | Oakville | Ontario | Canada | L6H 3P1 |
21 | The Ottawa Hospital /ID# 132329 | Ottawa | Ontario | Canada | K1H 8L6 |
22 | Dr. Sean Pierre Medicine Professional Corporation /ID# 137986 | Ottawa | Ontario | Canada | K2H 9N6 |
23 | Kawarth Urology Associates /ID# 116041 | Peterborough | Ontario | Canada | K9H 1T6 |
24 | The Medical Centre /ID# 128278 | Peterborough | Ontario | Canada | K9J 7B3 |
25 | Abara Medicine Professional Corporation /ID# 137270 | Richmond Hill | Ontario | Canada | L4C 3X5 |
26 | Dr. Petar Erdeljan Medicine Professional Corporation /ID# 139641 | Scarborough | Ontario | Canada | M1P 2T7 |
27 | 1837206 Ontario Inc. /Id# 116038 | Scarborough | Ontario | Canada | M1S 1T5 |
28 | Urology and Male Fertility /ID# 116043 | Scarborough | Ontario | Canada | M1S 4V5 |
29 | Northern Urology Centre /ID# 141391 | Sudbury | Ontario | Canada | P3E 3Z8 |
30 | Duplicate_Sunnybrook Health Sciences Ctr /ID# 136597 | Toronto | Ontario | Canada | M4N 3M5 |
31 | Princess Margaret Cancer Centre /ID# 137984 | Toronto | Ontario | Canada | M5G 2M9 |
32 | Toronto Urology Clin Study Grp /ID# 116044 | Toronto | Ontario | Canada | M6A 3B5 |
33 | Toronto West Urology Associates /ID# 116021 | Toronto | Ontario | Canada | M6S 4W4 |
34 | Toronto West Urology Associates /ID# 134134 | Toronto | Ontario | Canada | M6S 4W4 |
35 | Clinique d'urologie /ID# 116019 | Chicoutimi | Quebec | Canada | G7H 4J1 |
36 | CISSS - Hôpital de Gatineau /ID# 131309 | Gatineau | Quebec | Canada | J8P 7H2 |
37 | CISSS de la Monteregie /ID# 116036 | Greenfield Park | Quebec | Canada | J4V 2H1 |
38 | CISSS de la Monteregie /ID# 124296 | Greenfield Park | Quebec | Canada | J4V 2H1 |
39 | CISSS de la Monteregie /ID# 134137 | Greenfield Park | Quebec | Canada | J4V 2H1 |
40 | Clinique d'Urologie á Polyclinique Médicale Concorde /ID# 116037 | Laval | Quebec | Canada | H7G 2E6 |
41 | Hopital Cite-de-la-Sante /ID# 130951 | Laval | Quebec | Canada | H7M 3L9 |
42 | Montreal General Hospital - McGill University Health Center /ID# 141503 | Montreal | Quebec | Canada | H3G 1A4 |
43 | Jewish General Hospital /ID# 120416 | Montreal | Quebec | Canada | H3T 1E2 |
44 | CHUM - Notre-Dame Hospital /ID# 137271 | Montréal | Quebec | Canada | H2X 0A9 |
45 | Ultra-Med Research /ID# 116355 | Pointe-claire | Quebec | Canada | H9R 4S3 |
46 | CHUS - Hopital Fleurimont /ID# 124275 | Sherbrooke | Quebec | Canada | J1H 5N4 |
47 | Groupe De Recherche En Urologie De La Mauricie /ID# 116356 | Trois-rivieres | Quebec | Canada | G9A 3V7 |
48 | Ctr Sante et Services Sociaux /ID# 131230 | Trois-rivières | Quebec | Canada | G8Z 3R9 |
49 | Clinique des Spécialités Chirurgicales de Val-d'Or /ID# 116039 | Val D'or | Quebec | Canada | J9P 1W3 |
50 | 9120-1947 Quebec Inc. /ID# 129151 | Westmount, Montreal | Quebec | Canada | H3Z 2P9 |
Sponsors and Collaborators
- AbbVie
- JSS Medical Research; CMX Research Inc.; Canadian Urology Research Consortium
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P14-096