Web-based Lifestyle Trial Among Men With Prostate Cancer: Prostate 8

Study 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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Lifestyle intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1- Lifestyle Intervention<br>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. | Behavioral: Lifestyle intervention<br>* Patients will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive texts, and be provided with individualized lifestyle recommendations.<br>|
| No Intervention: Group 2 - Control<br>Men randomized to the control group will receive standard of care. They will receive access to the website and personalized lifestyle recommendations on the 8 healthy habits targeted in the study after the 3 month trial. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fitbit use | We will measure the number of days the Fitbit was used during the study period in the intervention arm only to assess study feasibility | 3 months | 
| text message use | 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 | 3 months | 
| website use - number of days the website was visited | 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 | 3 months | 
| website use - number of website visits | We will measure the total number of website visits in the intervention arm only during the study period to assess study feasibility | 3 months | 
| intervention acceptability | We will assess intervention acceptability via questionnaire at 3 months in the intervention group. | 3 months | 
| self-reported change in health behaviors | We will assess change in health behaviors via questionnaire at baseline and 3 months. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in physical activity measured by activity monitor | This is assessed via 7-day accelerometer measurements at baseline and 3 months. | 3 months | 
| change in task self-efficacy | We will assess confidence in performing behaviors via questionnaire at baseline and 3 months. | 3 months | 
| change in plasma antioxidant Vitamin E | We will assess Vitamin E levels at baseline and 3 months. | 3 months | 
| change in plasma antioxidant lycopene | We will assess lycopene levels at baseline and 3 months. | 3 months | 
| change in fasting glucose | We will assess fasting glucose at baseline and 3 months. | 3 months | 
| change in cholesterol | We will assess cholesterol at baseline and 3 months. | 3 months | 
| change in hemoglobin A1c | We will assess hemoglobin A1c at baseline and 3 months. | 3 months | 
| change in C-reactive protein | We will assess C-reactive protein at baseline and 3 months. | 3 months | 
| change in waist circumference | We will assess waist circumference at baseline and 3 months. | 3 months | 
| change in weight | We will assess weight at baseline and 3 months. | 3 months | 
| change in body mass index | We will assess body mass index at baseline and 3 months. | 3 months | 
| depression | Center for Epidemiologic Studies Depression Scale completed at baseline and 3 months. | 3 months | 
| anxiety | Memorial Anxiety Scale for Prostate Cancer and State Anxiety completed at baseline and 3 months. Trait anxiety completed at baseline. | 3 months | 
| health-related quality of life | Expanded Prostate Cancer Index Composite-26 and Short Form Health Survey-36 completed at baseline and 3 months. | 3 months | 
| maintenance or adoption of self-reported behaviors after 1 year | We will assess change in health behaviors via questionnaire at baseline, 3 months, and 1 year. | 1 year |