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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04057859
Other study ID # CMX-SC-2013-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2013
Est. completion date July 2020

Study information

Verified date January 2022
Source CMX Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this observational study is to examine the level of activity in the prostate cancer population treated with Androgen Deprivation Therapy (ADT).


Description:

The aim of the current observational study will be to examine the level of activity in the prostate cancer population treated with ADT therapy; specifically, the impact of physical activity levels along with nutritional guidance through physician support. The application of an innovative technology to motivate patients will also be examined through the provision of an accelerometer/pedometer (NIKE+ FuelBand). The physical activity will be monitored by a NIKE+ Fuelband or tracked on an activity log.This study will assess the clinical and patient reported outcomes relevant to the management of their prostate cancer, in conjunction with a program assessing daily physical activities and nutritional guidance on the impact on the patient's quality of life, mobility and weight maintenance.


Recruitment information / eligibility

Status Completed
Enrollment 271
Est. completion date July 2020
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male patient aged = 18 years old - Able to read and sign an approved Informed Consent Form (ICF) - Diagnosed with locally advanced or metastatic prostate cancer - Patient is treatment naive for ADT or has started ADT (3 or 4 month depot injection) AND has not received more than 1 treatment of 3 or 4 month ADT OR Patient is on intermittent therapy with an ADT agent and will be restarting ADT (3 or 4 month depot injection) - ECOG (Eastern Cooperative Oncology Group) score of = 2 - Willingness to track weekly physical activities with or without participating in a home based exercise program during the course of this study. The physical activities will be tracked with a weekly activity log or a NIKE+ Fuelband Exclusion Criteria: - Currently participating in a clinical study or observational study - Has a survival expectancy of < 2 years - Has any other condition that, in the opinion of the treating physician, may affect the patient's health or outcome of the trial

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Barrie Urology Group Barrie Ontario
Canada Euroscope Inc. Barrie Ontario
Canada Dr. Gregory Leal Belleville Ontario
Canada Jonathan Giddens Medical Professional Corp. Brampton Ontario
Canada Brantford Urology Research Brantford Ontario
Canada Kenneth Jansz Medical Professional Corp. Burlington Ontario
Canada Recherches Cliniques Theradev Granby Quebec
Canada Southern Interior Medical Research Inc. Kelowna British Columbia
Canada UroLaval Laval Quebec
Canada Hopital Maisonneuve-Rosemont Montreal Quebec
Canada Stanley Flax Medical Professional Corp. North York Ontario
Canada The Fe/Male Health Centre Oakville Ontario
Canada The Fe/Male Health Centres Oakville Ontario
Canada Kawartha Urology Peterborough Ontario
Canada Ultra-Med Inc. Pointe-Claire Quebec
Canada CHU de Quebec - L'hotel-dieu de Quebec Quebec City Quebec
Canada Urology Clinic Scarborough Ontario
Canada Centre de Recherche en Urologie de Lanaudiere St. Charles Borromee Quebec
Canada Michael L. Pianezza Medicine Professional Corp. Sudbury Ontario
Canada Northern Urology Centre Sudbury Ontario
Canada Dr. Jonathan Chan Medical Professional Corp. Toronto Ontario
Canada Umesh Jain Medicine Professional Corp. Toronto Ontario
Canada Silverado Research Inc. Victoria British Columbia

Sponsors (2)

Lead Sponsor Collaborator
CMX Research Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the patient quality of life (QoL) using the EORTC QLQ-C30 The EORTC QLQ-C30 is a questionnaire designed to measure quality of life of cancer patient. Month 0 to Month 36
Primary Changes in the patient quality of life (QoL) using the FACT-P The FACT-P (Functional Assessment of Cancer Therapy - Prostate) is a questionnaire used to assess the health-related quality of life in men with prostate cancer. Month 0 to Month 36
Primary Changes in the patient quality of life (QoL) using the FACIT Fatigue Scale The FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale is a questionnaire that measures an individuals level of fatigue during their usual daily activities over the past week. Month 0 to Month 36
Secondary Determine compliance of home-based exercises and regular physical activities To determine the compliance of home-based exercises and regular physical activities using a weekly activity log. 3 Years
Secondary Determine the impact of exercise and physician support on activity levels To determine the impact of exercise and physician support on activity levels using the weekly activity log, home diary or NIKE+ Fuelband. 3 Years
Secondary Assess the impact of nutritional guidance and exercise with physician support on BMI To determine if BMI (body mass index) scores decrease with nutritional guidance and exercise with physician support. 3 Years
Secondary Mobility of prostate cancer patients measured by TUG Test To assess the impact of nutritional guidance and exercise with physician support on the mobility of prostate cancer patients treated with ADT as measured by the Timed Up and Go Test (TUG) 3 Years
Secondary Determine the safety and tolerability of ADT in the management of prostate cancer Safety and tolerability will be assessed based on the number and type of adverse events collected over the study duration. 3 Years
Secondary # of patients who discontinued prescribed treatment or intermittent usage of prescribed treatment To determine # of patients who discontinued ADT therapy over the course of the study with reasons describing why. 3 Years
Secondary Mobility of prostate cancer patients measured by Five Times Sit to Stand Test (FTSST) To assess the impact of nutritional guidance and exercise with physician support on the mobility of prostate cancer patients treated with ADT as measured by the Five Times Sit to Stand Test (FTSST). 3 years
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