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Eligibility
for males ages 18 years and up
Location
at San Francisco, California
Dates
study started
estimated completion:

Description

Summary

A randomized controlled trial of a technology-based lifestyle intervention vs. usual care among men with low-risk prostate cancer to determine the acceptability and feasibility of the intervention and the effect of the intervention on behavior change related to exercise, diet, and not smoking.

Official Title

A Randomized Clinical Trial of Web-based Lifestyle Tools and Resources Versus Usual Care Among Men With Prostate Cancer

Details

This is a PI-initiated, randomized, unblinded, clinical trial of a technology-based 3 month lifestyle intervention vs. usual care among men with low risk prostate cancer. We will recruit and consent 76 men with prostate cancer at UCSF. The subjects will be asked to complete questionnaires, 7 days accelerometer measurement, body measurements (weight, waist, hip, pulse, blood pressure) and collection of blood specimen at baseline and 3 months. Subjects will be randomized into two arms (Intervention Group and Control Group). The Intervention Group (N=38) will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive text messages, and be provided with individualized lifestyle recommendations. The Control Group (N=38) will have standard of care and be asked to continue with their usual lifestyle habits. They will receive access to the lifestyle website and be provided with individualized lifestyle recommendations at 3 months.

Keywords

Prostate Cancer

Eligibility

You can join if…

Open to males ages 18 years and up

  1. patient must be in the UCSF Urologic Outcomes Database (UODB) and have consented to be contacted for future research
  2. have non-metastatic prostate cancer and ≤clinical T3a disease at diagnosis
  3. if receiving treatment, such as radical prostatectomy or radiation treatment, must be

    3 months prior to enrollment

  4. be able to speak and read English
  5. have no contra-indication to moderate to vigorous aerobic exercise
  6. have reliable access to the internet and willingness to access the website daily
  7. be willing and able to travel to UCSF for pre- and post-study blood collection and some body measurements (weight, waist and hip circumference, pulse, blood pressure)
  8. have ≤4 of 8 of the healthy behaviors at baseline, assessed via short questionnaire

You CAN'T join if...

  1. cT3a stage disease at diagnosis

  2. recently treated (within 3 months) with radical prostatectomy or radiation
  3. not able to speak and read English
  4. any uncontrolled illness of physical disability that contradicts moderate to vigorous aerobic exercise
  5. no reliable access to the internet
  6. unable to travel to UCSF for the pre- and post-study blood collection

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02470936
Study Type
Interventional
Last Updated
July 2016
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