Web-based Lifestyle Trial Among Men With Prostate Cancer: Prostate 8
NCT ID: NCT02470936
Last Updated: 2019-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2015-06-30
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
MALE
No
Sponsors
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American Cancer Society, Inc.
OTHER
Prostate Cancer Foundation
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Stacey Kenfield, ScD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco (UCSF)
San Francisco, California, United States
Countries
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References
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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.
Other Identifiers
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14-13555
Identifier Type: -
Identifier Source: org_study_id
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