Evaluation of Diet and Exercise in Prostate Cancer Patients

N/ACompletedNCT01960881

AbbVie1,331 enrolled

Overview

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

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

Enrollment

1,331

Conditions

Prostate Cancer

Eligibility

Min age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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)

Locations (50)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: From Month 0 to Month 18

Secondary Outcomes

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

Change in weight

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

Time frame: From Month 0 to Month 18

Change in Body Mass Index (BMI)

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.

Data from ClinicalTrials.gov

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Exdeo Clinical Research Inc /ID# 116040

Abbotsford British Columbia, British Columbia, Canada

Southern Interior Medical Research /ID# 116025

Kelowna, British Columbia, Canada

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

Victoria, British Columbia, Canada

CancerCare Manitoba /ID# 135976

Winnipeg, Manitoba, Canada

Saint John Regional Hospital /ID# 141302

Saint John, New Brunswick, Canada

QE II Health Sciences Centre /ID# 118941

Halifax, Nova Scotia, Canada

The Male/Female Hlth and Res /ID# 116042

Barrie, Ontario, Canada

The Male/Female Hlth and Res /ID# 124295

Barrie, Ontario, Canada

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

Belleville, Ontario, Canada

Jonathan Giddens Medicine /ID# 116023

Brampton, Ontario, Canada

...and 40 more locations

Time frame: From Month 0 to Month 18

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

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.

Time frame: From Month 0 to Month 18

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

An abridged 5 item self-administered questionnaire assessing the presence and severity of erectile dysfunction (for patients enrolled prior to protocol amendment 2)

Time frame: From Month 0 to Month 18

Number of patients with Adverse Events

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

Time frame: From Month 0 to Month 18

Changes in the patient's medical condition

Any change in the patient's medical condition including new onset or worsening of medical conditions.

Time frame: From Month 0 to Month 18

Proportion of patients with castrate levels of testosterone and undetectable levels of Prostatic Specific Antigen (PSA) at 18 months of treatments.

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.

Time frame: From Month 0 to Month 18

Leuprolide Acetate Utilization

Utilization of Leuprolide Acetate will be assessed.

Time frame: From Month 0 to Month 18

Changes in the Doctor-Patient communication (for patients enrolled prior to protocol amendment 2)

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

Time frame: From Month 0 to Month 18

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

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.

Time frame: From Month 0 to Month 18

Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1)

Measured with a self-reported questionnaire.

Time frame: Up to Month 18

Lupron Cares Patient Support Program

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

Time frame: Up to Month 18