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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02470936

14-13555

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Group 1- Lifestyle Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle intervention

Group 2 - Control

No Intervention group

Description:

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.