Prostate Cancer
Conditions
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.
Interventions
BEHAVIORALLifestyle intervention
Patients will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive texts, and be provided with individualized lifestyle recommendations.
Sponsors
American Cancer Society, Inc.
Prostate Cancer Foundation
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| intervention acceptability | 3 months | We will assess intervention acceptability via questionnaire at 3 months in the intervention group. |
| self-reported change in health behaviors | 3 months | We will assess change in health behaviors via questionnaire at baseline and 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 plasma antioxidant Vitamin E | 3 months | We will assess Vitamin E levels at baseline and 3 months. |
| change in plasma antioxidant lycopene | 3 months | We will assess lycopene levels at baseline and 3 months. |
| change in fasting glucose | 3 months | We will assess fasting glucose at baseline and 3 months. |
| change in cholesterol | 3 months | We will assess cholesterol at baseline and 3 months. |
| 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. |
| change in waist circumference | 3 months | We will assess waist circumference 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. |
| depression | 3 months | Center for Epidemiologic Studies Depression Scale completed 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed