Evaluation of Diet and Exercise in Prostate Cancer Patients

NCT01960881 | Completed

• 1 other identifier: P14-096
• Study Type: observational
• Target: 1,331
• Locations: 1 country
• Sites: 50

Brief Summary

Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed with Lupron.

Conditions

Prostate Cancer

Keywords

Prostate cancer

Outcome Measures

Primary Outcomes (3)

• Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)

  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.

  From Month 0 to Month 18

• Change in exercise duration

  Assessed at every visit what was the amount of various types of exercise performed in the previous month.

  From Month 0 to Month 18

• Change in dietary habits

  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.

  From Month 0 to Month 18

Secondary Outcomes (13)

• 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

• Change in weight

  From Month 0 to Month 18

• Change in Body Mass Index (BMI)

  From Month 0 to Month 18

• Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI)

  From Month 0 to Month 18

• Changes in the sexual function using the International Index of Erectile Function (IIEF-5)

  From Month 0 to Month 18

Study Arms (1)

Prostate Cancer Patients

Prostate Cancer Patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled from the offices of University or community urologists/radio-oncologists across Canada treating patients with PCa

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AbbVie: lead
• JSS Medical Research; CMX Research Inc.; Canadian Urology Research Consortium: collaborator

Study Sites (50)

Exdeo Clinical Research Inc /ID# 116040

Abbotsford, British Columbia, V2T 1X8, Canada

Location

Southern Interior Medical Research /ID# 116025

Kelowna, British Columbia, V1W 4V5, Canada

Location

Dr. J. Paul Whelan, Inc. /ID# 120415

Victoria, British Columbia, V8V 3N1, Canada

Location

CancerCare Manitoba /ID# 135976

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Saint John Regional Hospital /ID# 141302

Saint John, New Brunswick, E2L 4L2, Canada

Location

QE II Health Sciences Centre /ID# 118941

Halifax, Nova Scotia, B3H 1V7, Canada

Location

The Male/Female Hlth and Res /ID# 116042

Barrie, Ontario, L4M 7G1, Canada

Location

The Male/Female Hlth and Res /ID# 124295

Barrie, Ontario, L4M 7G1, Canada

Location

Edward F.A. Woods Medicine Professional Corporation /ID# 120695

Belleville, Ontario, K8P 3Z9, Canada

Location

Jonathan Giddens Medicine /ID# 116023

Brampton, Ontario, L6T 4S5, Canada

Location

Brantford Urology Research /ID# 116026

Brantford, Ontario, N3S 6T6, Canada

Location

G. Kenneth Jansz Medicine Professional Corporation /ID# 116024

Burlington, Ontario, L7N 3V2, Canada

Location

William R. Love, Medicine, Professional Corporation /ID# 116035

Burlington, Ontario, L7S 1V2, Canada

Location

Northern Urology Centre /ID# 141391

Greater Sudbury, Ontario, P3E 3Z8, Canada

Location

St. Joseph's Healthcare /ID# 163973

Hamilton, Ontario, L8N 4A6, Canada

Location

Queen's University /ID# 137983

Kingston, Ontario, K7L 3J7, Canada

Location

London Health Sciences Center /ID# 118940

London, Ontario, N6A 5W9, Canada

Location

DiCostanzo, Markham, CA /ID# 137272

Markham, Ontario, L6B 0T1, Canada

Location

Mor Urology Inc /ID# 116027

Newmarket, Ontario, L3X 1W1, Canada

Location

Stanley Flax Medical Prof Corp /ID# 116022

North YORK, Ontario, M2J 1V1, Canada

Location

Fe/Male Health Centers /ID# 116020

Oakville, Ontario, L6H 3P1, Canada

Location

The Ottawa Hospital /ID# 132329

Ottawa, Ontario, K1H 8L6, Canada

Location

Dr. Sean Pierre Medicine Professional Corporation /ID# 137986

Ottawa, Ontario, K2H 9N6, Canada

Location

Kawarth Urology Associates /ID# 116041

Peterborough, Ontario, K9H 1T6, Canada

Location

The Medical Centre /ID# 128278

Peterborough, Ontario, K9J 7B3, Canada

Location

Abara Medicine Professional Corporation /ID# 137270

Richmond Hill, Ontario, L4C 3X5, Canada

Location

Dr. Petar Erdeljan Medicine Professional Corporation /ID# 139641

Scarborough Village, Ontario, M1P 2T7, Canada

Location

1837206 Ontario Inc. /Id# 116038

Scarborough Village, Ontario, M1S 1T5, Canada

Location

Urology and Male Fertility /ID# 116043

Scarborough Village, Ontario, M1S 4V5, Canada

Location

Duplicate_Sunnybrook Health Sciences Ctr /ID# 136597

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre /ID# 137984

Toronto, Ontario, M5G 2M9, Canada

Location

Toronto Urology Clin Study Grp /ID# 116044

Toronto, Ontario, M6A 3B5, Canada

Location

Toronto West Urology Associates /ID# 116021

Toronto, Ontario, M6S 4W4, Canada

Location

Toronto West Urology Associates /ID# 134134

Toronto, Ontario, M6S 4W4, Canada

Location

Clinique d'urologie /ID# 116019

Chicoutimi, Quebec, G7H 4J1, Canada

Location

CISSS - Hôpital de Gatineau /ID# 131309

Gatineau, Quebec, J8P 7H2, Canada

Location

CISSS de la Monteregie /ID# 116036

Greenfield Park, Quebec, J4V 2H1, Canada

Location

CISSS de la Monteregie /ID# 124296

Greenfield Park, Quebec, J4V 2H1, Canada

Location

CISSS de la Monteregie /ID# 134137

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Clinique d'Urologie á Polyclinique Médicale Concorde /ID# 116037

Laval, Quebec, H7G 2E6, Canada

Location

Hopital Cite-de-la-Sante /ID# 130951

Laval, Quebec, H7M 3L9, Canada

Location

CHUM - Notre-Dame Hospital /ID# 137271

Montreal, Quebec, H2X 0A9, Canada

Location

Montreal General Hospital - McGill University Health Center /ID# 141503

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital /ID# 120416

Montreal, Quebec, H3T 1E2, Canada

Location

Ultra-Med Research /ID# 116355

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

CHUS - Hopital Fleurimont /ID# 124275

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Ctr Sante et Services Sociaux /ID# 131230

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Groupe De Recherche En Urologie De La Mauricie /ID# 116356

Trois-Rivières, Quebec, G9A 3V7, Canada

Location

Clinique des Spécialités Chirurgicales de Val-d'Or /ID# 116039

Val-d'Or, Quebec, J9P 1W3, Canada

Location

9120-1947 Quebec Inc. /ID# 129151

Westmount, Montreal, Quebec, H3Z 2P9, Canada

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: September 19, 2013
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

CA (50)