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

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ClinicalTrials.gov Identifier: NCT01960881
Recruitment Status : Active, not recruiting
First Posted : October 11, 2013
Last Update Posted : April 28, 2020
Sponsor:
Collaborators:
JSS Medical Research Inc.
CMX Research
Canadian Urology Research Consortium
Information provided by (Responsible Party):
AbbVie

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

Condition or disease
Prostate Cancer

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.

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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 : September 19, 2013
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Prostate Cancer Patients
Prostate Cancer Patients



Primary Outcome Measures :
  1. 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.

  2. Change in exercise duration [ Time Frame: 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 [ 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 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) [ Time Frame: 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 [ Time Frame: 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) [ 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.

  4. 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.

  5. 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 (for patients enrolled prior to protocol amendment 2)

  6. 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

  7. 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.

  8. Proportion of patients with castrate levels of testosterone and undetectable 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.

  9. Leuprolide Acetate Utilization [ Time Frame: 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) [ 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

  11. Caregiver Quality of Life (for patients enrolled under protocol amendment 1) [ 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.

  12. Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1) [ Time Frame: Up to Month 18 ]
    Measured with a self-reported questionnaire.

  13. Lupron Cares Patient Support Program [ Time Frame: Up to Month 18 ]
    Enrollment and use will be assessed for the patient support program.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
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. 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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960881


Locations
Show Show 50 study locations
Sponsors and Collaborators
AbbVie
JSS Medical Research Inc.
CMX Research
Canadian Urology Research Consortium
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01960881    
Other Study ID Numbers: P14-096
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases