Evaluation of Diet and Exercise in Prostate Cancer Patients

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT01960881
• Lead Sponsor: AbbVie

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 Timeline

• Study Start: 2013-09-19
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 1331

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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

Name	Time	Method
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.
Change in weight	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)	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.
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.
Lupron Cares Patient Support Program	Up to Month 18	Enrollment and use will be assessed for the patient support program.
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.
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.
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.
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
Leuprolide Acetate Utilization	From Month 0 to Month 18	Utilization of Leuprolide Acetate will be assessed.
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.
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)
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

Trial Locations

Locations (50)

Exdeo Clinical Research Inc /ID# 116040; 🇨🇦 Abbotsford, 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

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