Web-based Lifestyle Trial Among Men With Prostate Cancer: Prostate 8
- Conditions
- Prostate Cancer
- Interventions
- Behavioral: Lifestyle intervention
- Registration Number
- NCT02470936
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 76
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1- Lifestyle Intervention Lifestyle intervention Men will receive a web-based, personalized lifestyle program. They will receive personalized prostate cancer-specific lifestyle recommendations on specific habits based on their eligibility survey responses. They will have access to the website composed of four topic areas (get active, eat well, stop smoking, and find support), receive a Fitbit and access to a Fitbit account and community group, and receive text messages and refrigerator magnet to reinforce behaviors. The website will be updated frequently with new tips and material and two weekly blogs will be maintained. Final content is reviewed by study investigators and patient advocates. Men will complete an intervention acceptability survey (acceptability of the website and intervention components) at 3 months.
- Primary Outcome Measures
Name Time Method intervention acceptability 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 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 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 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 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 3 months We will assess change in health behaviors via questionnaire at baseline and 3 months.
- Secondary Outcome Measures
Name Time Method change in plasma antioxidant lycopene 3 months We will assess lycopene levels at baseline and 3 months.
maintenance or adoption of self-reported behaviors after 1 year 1 year We will assess change in health behaviors via questionnaire at baseline, 3 months, and 1 year.
change in fasting glucose 3 months We will assess fasting glucose at baseline and 3 months.
change in physical activity measured by activity monitor 3 months This is assessed via 7-day accelerometer measurements at baseline and 3 months.
change in task self-efficacy 3 months We will assess confidence in performing behaviors via questionnaire at baseline and 3 months.
change in cholesterol 3 months We will assess cholesterol at baseline and 3 months.
change in waist circumference 3 months We will assess waist circumference at baseline and 3 months.
health-related quality of life 3 months Expanded Prostate Cancer Index Composite-26 and Short Form Health Survey-36 completed at baseline and 3 months.
change in plasma antioxidant Vitamin E 3 months We will assess Vitamin E levels at baseline and 3 months.
change in weight 3 months We will assess weight at baseline and 3 months.
change in body mass index 3 months We will assess body mass index at baseline and 3 months.
anxiety 3 months Memorial Anxiety Scale for Prostate Cancer and State Anxiety completed at baseline and 3 months. Trait anxiety completed at baseline.
change in hemoglobin A1c 3 months We will assess hemoglobin A1c at baseline and 3 months.
change in C-reactive protein 3 months We will assess C-reactive protein at baseline and 3 months.
depression 3 months Center for Epidemiologic Studies Depression Scale completed at baseline and 3 months.
Trial Locations
- Locations (1)
University of California, San Francisco (UCSF)
🇺🇸San Francisco, California, United States