Evaluation of Diet and Exercise in Prostate Cancer Patients (CRONOS II)
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|ClinicalTrials.gov Identifier: NCT01960881|
Recruitment Status : Recruiting
First Posted : October 11, 2013
Last Update Posted : April 24, 2019
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||1300 participants|
|Official Title:||Canadian Real Life Evaluation of Exercise and Diet in Patients Treated With Lupron® for the Management of Prostate Cancer:(CRONOS II)|
|Actual Study Start Date :||September 19, 2013|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||July 30, 2021|
Prostate Cancer Patients
Prostate Cancer Patients
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960881
|Contact: Isabelle Defoyemail@example.com|
|Contact: Marie-Josee Fournellefirstname.lastname@example.org|
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|Study Director:||AbbVie Inc.||AbbVie|