A Randomized Clinical Trial of Web-based Lifestyle Tools and Resources Versus Usual Care Among Men With Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University of California, San Francisco
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- intervention acceptability
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
A randomized controlled trial of a technology-based lifestyle intervention vs. usual care among men with low-risk prostate cancer to determine the feasibility and acceptability of the intervention and the effect of the intervention on behavior change related to exercise, diet, and not smoking.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •clinical stage ≤T3a nonmetastatic prostate cancer within 5 years
- •completion of treatment ≥3 months prior to enrollment, if not on active surveillance
- •ability to walk unassisted
- •be able to speak and read English
- •ability to navigate websites and email, and have internet access
- •able to travel to UCSF for pre- and post-study blood collection
Exclusion Criteria
- •any contraindications to moderate or vigorous aerobic exercise
- •psychiatric condition preventing the patient from giving informed consent or adhering to the study protocol
- •reporting adherence to more than 4 of the 8 targeted lifestyle behaviors via questionnaires at screening
Outcomes
Primary Outcomes
intervention acceptability
Time Frame: 3 months
We will assess intervention acceptability via questionnaire at 3 months in the intervention group.
website use - number of days the website was visited
Time Frame: 3 months
We will measure the total number of days the website was visited in the intervention arm only during the study period to assess study feasibility
Fitbit use
Time Frame: 3 months
We will measure the number of days the Fitbit was used during the study period in the intervention arm only to assess study feasibility
website use - number of website visits
Time Frame: 3 months
We will measure the total number of website visits in the intervention arm only during the study period to assess study feasibility
text message use
Time Frame: 3 months
We will measure the number of text messages responded to that required a reply in the intervention arm only during the study period to assess study feasibility
self-reported change in health behaviors
Time Frame: 3 months
We will assess change in health behaviors via questionnaire at baseline and 3 months.
Secondary Outcomes
- maintenance or adoption of self-reported behaviors after 1 year(1 year)
- change in fasting glucose(3 months)
- change in physical activity measured by activity monitor(3 months)
- change in task self-efficacy(3 months)
- change in plasma antioxidant lycopene(3 months)
- change in cholesterol(3 months)
- change in waist circumference(3 months)
- health-related quality of life(3 months)
- change in plasma antioxidant Vitamin E(3 months)
- change in weight(3 months)
- change in body mass index(3 months)
- anxiety(3 months)
- change in hemoglobin A1c(3 months)
- change in C-reactive protein(3 months)
- depression(3 months)