Clinical trial NCT02470936: Web-based Lifestyle Trial Among Men With Prostate Cancer: Prostate 8
Official title: A Randomized Clinical Trial of Web-based Lifestyle Tools and Resources Versus Usual Care Among Men With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Prostate Cancer Foundation
First posted: 2015-06-12
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fitbit use
timeFrame: 3 months
measure: text message use
timeFrame: 3 months
measure: website use - number of days the website was visited
timeFrame: 3 months
measure: website use - number of website visits
timeFrame: 3 months
measure: intervention acceptability
timeFrame: 3 months
measure: self-reported change in health behaviors
timeFrame: 3 months
Secondary outcomes:
measure: change in physical activity measured by activity monitor
timeFrame: 3 months
measure: change in task self-efficacy
timeFrame: 3 months
measure: change in plasma antioxidant Vitamin E
timeFrame: 3 months
measure: change in plasma antioxidant lycopene
timeFrame: 3 months
measure: change in fasting glucose
timeFrame: 3 months
measure: change in cholesterol
timeFrame: 3 months
measure: change in hemoglobin A1c
timeFrame: 3 months
measure: change in C-reactive protein
timeFrame: 3 months
measure: change in waist circumference
timeFrame: 3 months
measure: change in weight
timeFrame: 3 months
measure: change in body mass index
timeFrame: 3 months
measure: depression
timeFrame: 3 months
measure: anxiety
timeFrame: 3 months
measure: health-related quality of life
timeFrame: 3 months
measure: maintenance or adoption of self-reported behaviors after 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stacey Kenfield, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kenfield SA, Van Blarigan EL, Ameli N, Lavaki E, Cedars B, Paciorek AT, Monroy C, Tantum LK, Newton RU, Signorell C, Suh JH, Zhang L, Cooperberg MR, Carroll PR, Chan JM. Feasibility, Acceptability, and Behavioral Outcomes from a Technology-enhanced Behavioral Change Intervention (Prostate 8): A Pilot Randomized Controlled Trial in Men with Prostate Cancer. Eur Urol. 2019 Jun;75(6):950-958. doi: 10.1016/j.eururo.2018.12.040. Epub 2019 Jan 10.