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

Condition: Prostate Cancer

Intervention:

• Behavioral: Lifestyle intervention

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02470936

Sponsor: University of California, San Francisco

Primary Outcome Measures:

• Measure: Fitbit use
• Time Frame: 3 months
• Safety Issue:
• Measure: text message use
• Time Frame: 3 months
• Safety Issue:
• Measure: website use – number of days the website was visited
• Time Frame: 3 months
• Safety Issue:
• Measure: website use – number of website visits
• Time Frame: 3 months
• Safety Issue:
• Measure: intervention acceptability
• Time Frame: 3 months
• Safety Issue:
• Measure: self-reported change in health behaviors
• Time Frame: 3 months
• Safety Issue:

Secondary Outcome Measures:

• Measure: change in physical activity measured by activity monitor
• Time Frame: 3 months
• Safety Issue:
• Measure: change in task self-efficacy
• Time Frame: 3 months
• Safety Issue:
• Measure: change in plasma antioxidant Vitamin E
• Time Frame: 3 months
• Safety Issue:
• Measure: change in plasma antioxidant lycopene
• Time Frame: 3 months
• Safety Issue:
• Measure: change in fasting glucose
• Time Frame: 3 months
• Safety Issue:
• Measure: change in cholesterol
• Time Frame: 3 months
• Safety Issue:
• Measure: change in hemoglobin A1c
• Time Frame: 3 months
• Safety Issue:
• Measure: change in C-reactive protein
• Time Frame: 3 months
• Safety Issue:
• Measure: change in waist circumference
• Time Frame: 3 months
• Safety Issue:
• Measure: change in weight
• Time Frame: 3 months
• Safety Issue:
• Measure: change in body mass index
• Time Frame: 3 months
• Safety Issue:
• Measure: depression
• Time Frame: 3 months
• Safety Issue:
• Measure: anxiety
• Time Frame: 3 months
• Safety Issue:
• Measure: health-related quality of life
• Time Frame: 3 months
• Safety Issue:
• Measure: maintenance or adoption of self-reported behaviors after 1 year
• Time Frame: 1 year
• Safety Issue:

Estimated Enrollment: 76

Study Start Date: June 2015

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. clinical stage ≤T3a nonmetastatic prostate cancer within 5 years
2. completion of treatment ≥3 months prior to enrollment, if not on active surveillance
3. ability to walk unassisted
4. be able to speak and read English
5. ability to navigate websites and email, and have internet access
6. able to travel to UCSF for pre- and post-study blood collection

Exclusion Criteria:

1. any contraindications to moderate or vigorous aerobic exercise
2. psychiatric condition preventing the patient from giving informed consent or adhering to the study protocol
3. reporting adherence to more than 4 of the 8 targeted lifestyle behaviors via questionnaires at screening

Location:

• University of California, San Francisco (UCSF)
• San Francisco California 94143 United States

View trial on ClinicalTrials.gov