Evaluation of Diet and Exercise in Prostate Cancer Patients
- Conditions
- Prostate Cancer
- Registration Number
- NCT01960881
- Lead Sponsor
- AbbVie
- Brief Summary
Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed with Lupron.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 1331
i. Adult ≥ 18 years old
ii. Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.
iii. Diagnosed with PCa.
iv. Prescribed Lupron as part of his treatment by his treating physician.
i. Patient cannot or will not sign informed consent.
ii. 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.
iii. More than 6 months of therapy if currently on continuous Luteinizing hormone-releasing hormone (LHRH) treatment.
iv. If at study enrollment the intent is to only prescribe 1 dose of Lupron (leuprolide acetate)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
Lupron Cares Patient Support Program Up to Month 18 Enrollment and use will be assessed for the patient support program.
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 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.
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
Leuprolide Acetate Utilization From Month 0 to Month 18 Utilization of Leuprolide Acetate will be assessed.
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.
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)
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
Trial Locations
- Locations (50)
Exdeo Clinical Research Inc /ID# 116040
🇨🇦Abbotsford, British Columbia, Canada
Dr. J. Paul Whelan, Inc. /ID# 120415
🇨🇦Victoria, British Columbia, Canada
QE II Health Sciences Centre /ID# 118941
🇨🇦Halifax, Nova Scotia, Canada
Saint John Regional Hospital /ID# 141302
🇨🇦Saint John, New Brunswick, Canada
The Male/Female Hlth and Res /ID# 116042
🇨🇦Barrie, Ontario, Canada
CancerCare Manitoba /ID# 135976
🇨🇦Winnipeg, Manitoba, Canada
The Male/Female Hlth and Res /ID# 124295
🇨🇦Barrie, Ontario, Canada
Edward F.A. Woods Medicine Professional Corporation /ID# 120695
🇨🇦Belleville, Ontario, Canada
Jonathan Giddens Medicine /ID# 116023
🇨🇦Brampton, Ontario, Canada
Brantford Urology Research /ID# 116026
🇨🇦Brantford, Ontario, Canada
G. Kenneth Jansz Medicine Professional Corporation /ID# 116024
🇨🇦Burlington, Ontario, Canada
Queen's University /ID# 137983
🇨🇦Kingston, Ontario, Canada
Mor Urology Inc /ID# 116027
🇨🇦Newmarket, Ontario, Canada
St. Joseph's Healthcare /ID# 163973
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Center /ID# 118940
🇨🇦London, Ontario, Canada
William R. Love, Medicine, Professional Corporation /ID# 116035
🇨🇦Burlington, Ontario, Canada
DiCostanzo, Markham, CA /ID# 137272
🇨🇦Markham, Ontario, Canada
Fe/Male Health Centers /ID# 116020
🇨🇦Oakville, Ontario, Canada
The Ottawa Hospital /ID# 132329
🇨🇦Ottawa, Ontario, Canada
Stanley Flax Medical Prof Corp /ID# 116022
🇨🇦North York, Ontario, Canada
Kawarth Urology Associates /ID# 116041
🇨🇦Peterborough, Ontario, Canada
Dr. Sean Pierre Medicine Professional Corporation /ID# 137986
🇨🇦Ottawa, Ontario, Canada
The Medical Centre /ID# 128278
🇨🇦Peterborough, Ontario, Canada
Abara Medicine Professional Corporation /ID# 137270
🇨🇦Richmond Hill, Ontario, Canada
Dr. Petar Erdeljan Medicine Professional Corporation /ID# 139641
🇨🇦Scarborough, Ontario, Canada
1837206 Ontario Inc. /Id# 116038
🇨🇦Scarborough, Ontario, Canada
Urology and Male Fertility /ID# 116043
🇨🇦Scarborough, Ontario, Canada
Princess Margaret Cancer Centre /ID# 137984
🇨🇦Toronto, Ontario, Canada
Duplicate_Sunnybrook Health Sciences Ctr /ID# 136597
🇨🇦Toronto, Ontario, Canada
Northern Urology Centre /ID# 141391
🇨🇦Sudbury, Ontario, Canada
Toronto Urology Clin Study Grp /ID# 116044
🇨🇦Toronto, Ontario, Canada
Toronto West Urology Associates /ID# 116021
🇨🇦Toronto, Ontario, Canada
Toronto West Urology Associates /ID# 134134
🇨🇦Toronto, Ontario, Canada
CISSS - Hôpital de Gatineau /ID# 131309
🇨🇦Gatineau, Quebec, Canada
Clinique d'Urologie á Polyclinique Médicale Concorde /ID# 116037
🇨🇦Laval, Quebec, Canada
Clinique d'urologie /ID# 116019
🇨🇦Chicoutimi, Quebec, Canada
CISSS de la Monteregie /ID# 124296
🇨🇦Greenfield Park, Quebec, Canada
Montreal General Hospital - McGill University Health Center /ID# 141503
🇨🇦Montreal, Quebec, Canada
CISSS de la Monteregie /ID# 116036
🇨🇦Greenfield Park, Quebec, Canada
CISSS de la Monteregie /ID# 134137
🇨🇦Greenfield Park, Quebec, Canada
Hopital Cite-de-la-Sante /ID# 130951
🇨🇦Laval, Quebec, Canada
CHUM - Notre-Dame Hospital /ID# 137271
🇨🇦Montréal, Quebec, Canada
Jewish General Hospital /ID# 120416
🇨🇦Montreal, Quebec, Canada
Ultra-Med Research /ID# 116355
🇨🇦Pointe-claire, Quebec, Canada
Clinique des Spécialités Chirurgicales de Val-d'Or /ID# 116039
🇨🇦Val D'or, Quebec, Canada
Ctr Sante et Services Sociaux /ID# 131230
🇨🇦Trois-rivières, Quebec, Canada
Groupe De Recherche En Urologie De La Mauricie /ID# 116356
🇨🇦Trois-rivieres, Quebec, Canada
9120-1947 Quebec Inc. /ID# 129151
🇨🇦Westmount, Montreal, Quebec, Canada
Southern Interior Medical Research /ID# 116025
🇨🇦Kelowna, British Columbia, Canada
CHUS - Hopital Fleurimont /ID# 124275
🇨🇦Sherbrooke, Quebec, Canada