Clinical trial · Interventional
Web-based Lifestyle Trial Among Men With Prostate Cancer: Prostate 8
A Randomized Clinical Trial of Web-based Lifestyle Tools and Resources Versus Usual Care Among Men With Prostate Cancer
NCT02470936CI-TRIAL-00037241Prostate 8completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifestyle intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1- Lifestyle Intervention
- 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.
- interventionNames
- Behavioral: Lifestyle intervention
- type
- NO_INTERVENTION
- label
- Group 2 - Control
- 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.
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDKenfield 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. PMID 30638635