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

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

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 Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Lifestyle intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1- 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.	Behavioral: Lifestyle 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.
No Intervention: Group 2 - Control; 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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: American Cancer Society, Inc.; Prostate Cancer Foundation
• Investigators: Principal Investigator: Stacey Kenfield, ScD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 12, 2015

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 14-13555