CRONOS II: Evaluation of Diet and Exercise in Prostate Cancer Patients

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT01960881
Collaborator
JSS Medical Research; CMX Research Inc.; Canadian Urology Research Consortium (Other)
1,331
50
94.7
26.6
0.3

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

    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

    Study Type:
    Observational
    Actual Enrollment :
    1331 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed With Lupron (CRONOS II)
    Actual Study Start Date :
    Sep 19, 2013
    Actual Primary Completion Date :
    Aug 10, 2021
    Actual Study Completion Date :
    Aug 10, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Prostate Cancer Patients

    Prostate Cancer Patients

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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

    1. 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.

    2. Change in weight [From Month 0 to Month 18]

      Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

    3. 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.

    4. 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.

    5. 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)

    6. 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

    7. 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.

    8. 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.

    9. Leuprolide Acetate Utilization [From Month 0 to Month 18]

      Utilization of Leuprolide Acetate will be assessed.

    10. 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

    11. 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.

    12. 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.

    13. Lupron Cares Patient Support Program [Up to Month 18]

      Enrollment and use will be assessed for the patient support program.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Adult ≥ 18 years old

    2. Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.

    3. Diagnosed with PCa.

    4. Prescribed Lupron as part of his treatment by his treating physician.

    Exclusion Criteria:
    1. Patient cannot or will not sign informed consent.

    2. 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.

    3. More than 6 months of therapy if currently on continuous Luteinizing hormone-releasing hormone (LHRH) treatment.

    4. 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
    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.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT01960881
    Other Study ID Numbers:
    • P14-096
    First Posted:
    Oct 11, 2013
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2022