Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Diet and Exercise in Prostate Cancer Patients (CRONOS II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01960881
Recruitment Status : Recruiting
First Posted : October 11, 2013
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
JSS Medical Research Inc.
CMX Research
Canadian Urology Research Consortium
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date October 9, 2013
First Posted Date October 11, 2013
Last Update Posted Date April 24, 2019
Actual Study Start Date September 19, 2013
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2018)
  • Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36) [ Time Frame: 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 [ Time Frame: From Month 0 to Month 18 ]
    Assessed at every visit what was the amount of exercise performed from the previous month.
  • Change in dietary habits [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: October 9, 2013)
Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36) [ Time Frame: From Month 0 to Month 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.
Change History Complete list of historical versions of study NCT01960881 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 8, 2018)
  • Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI) [ Time Frame: 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 Doctor-Patient communication [ Time Frame: 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
  • Changes in the proportion of patients with castrate levels of testosterone and normal levels of Prostatic Specific Antigen (PSA) at 18 months of treatments. [ Time Frame: 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.
  • Changes in the sexual function using the International Index of Erectile Function (IIEF-5) [ Time Frame: From Month 0 to Month 18 ]
    An abridged 5 item self-administered questionnaire assessing the presence and severity of erectile dysfunction.
  • Changes in the patient's medical condition [ Time Frame: From Month 0 to Month 18 ]
    Any change in the patient's medical condition including new onset or worsening of medical conditions.
  • Number of patients with Adverse Events [ Time Frame: 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
  • Change in weight [ Time Frame: 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) [ Time Frame: 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.
  • Leuprolide Acetate Utilization [ Time Frame: From Month 0 to Month 18 ]
    Utilization of Leuprolide Acetate will be assessed.
  • Assessment of FInancial Burden on Patient's Family [ Time Frame: Up to Month 18 ]
    Measured with a self-reported questionnaire.
  • Lupron Cares Patient Support Program [ Time Frame: Up to Month 18 ]
    Enrollment and use will be assessed for the patient support program.
  • Caregiver Quality of Life [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: October 9, 2013)
  • Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI) [ Time Frame: From Month 0 to Month 36 ]
    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) [ Time Frame: From Month 0 to Month 36 ]
    An abridged 5 item self-administered questionnaire assessing the presence and severity of erectile dysfunction.
  • Changes in the proportion of patients with castrate levels of testosterone and normal levels of Prostatic Specific Antigen (PSA) at 36 months of treatments. [ Time Frame: From Month 0 to Month 36 ]
    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 [ Time Frame: From Month 0 to Month 36 ]
    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 [ Time Frame: From Month 0 to Month 36 ]
    Any change in the patient's medical condition including new onset or worsening of medical conditions.
  • Changes in the Doctor-Patient communication [ Time Frame: From Month 0 to Month 36 ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Diet and Exercise in Prostate Cancer Patients
Official Title Canadian Real Life Evaluation of Exercise and Diet in Patients Treated With Lupron® for the Management of Prostate Cancer:(CRONOS II)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Prostate Cancer Patients
Prostate Cancer Patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 19, 2018)
1300
Original Estimated Enrollment
 (submitted: October 9, 2013)
860
Estimated Study Completion Date July 30, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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. Survival expectancy less than 2-3 years as per the treating physician judgment

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

v. If at study enrollment the intent is to only prescribe 1 dose of Lupron (leuprolide acetate)

Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Isabelle Defoy 4382585150 isabelle.defoy@abbvie.com
Contact: Marie-Josee Fournelle 5148327307 marie-josee.fournelle@abbvie.com
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01960881
Other Study ID Numbers P14-096
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators
  • JSS Medical Research Inc.
  • CMX Research
  • Canadian Urology Research Consortium
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date April 2019