A Prospective, Single Arm Study in Prostate Cancer Patients Managed With Androgen Deprivation Therapy to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training (ELIFIT)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer of the Prostate
- Sponsor
- CMX Research
- Enrollment
- 271
- Locations
- 23
- Primary Endpoint
- Changes in the patient quality of life (QoL) using the FACIT Fatigue Scale
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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).
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Changes in the patient quality of life (QoL) using the FACIT Fatigue Scale
Time Frame: Month 0 to Month 36
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.
Changes in the patient quality of life (QoL) using the EORTC QLQ-C30
Time Frame: Month 0 to Month 36
The EORTC QLQ-C30 is a questionnaire designed to measure quality of life of cancer patient.
Changes in the patient quality of life (QoL) using the FACT-P
Time Frame: Month 0 to Month 36
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.
Secondary Outcomes
- # of patients who discontinued prescribed treatment or intermittent usage of prescribed treatment(3 Years)
- Mobility of prostate cancer patients measured by Five Times Sit to Stand Test (FTSST)(3 years)
- Determine compliance of home-based exercises and regular physical activities(3 Years)
- Determine the impact of exercise and physician support on activity levels(3 Years)
- Determine the safety and tolerability of ADT in the management of prostate cancer(3 Years)
- Assess the impact of nutritional guidance and exercise with physician support on BMI(3 Years)
- Mobility of prostate cancer patients measured by TUG Test(3 Years)