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

NCT02470936 | Completed DMC

• 1 other identifier: 14-13555
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (15)

• change in physical activity measured by activity monitor

  3 months

• change in task self-efficacy

  3 months

• change in plasma antioxidant Vitamin E

  3 months

• change in plasma antioxidant lycopene

  3 months

• change in fasting glucose

  3 months

Study Arms (2)

Group 1- Lifestyle Intervention

EXPERIMENTAL

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

Group 2 - Control

NO INTERVENTION

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.

Interventions

Lifestyle intervention BEHAVIORAL

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 1- Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical stage ≤T3a nonmetastatic prostate cancer within 5 years
• completion of treatment ≥3 months prior to enrollment, if not on active surveillance
• ability to walk unassisted
• be able to speak and read English
• ability to navigate websites and email, and have internet access
• able to travel to UCSF for pre- and post-study blood collection

You may not qualify if:

• any contraindications to moderate or vigorous aerobic exercise
• psychiatric condition preventing the patient from giving informed consent or adhering to the study protocol
• reporting adherence to more than 4 of the 8 targeted lifestyle behaviors via questionnaires at screening

Sponsors & Collaborators

• University of California, San Francisco: lead
• American Cancer Society, Inc.: collaborator
• Prostate Cancer Foundation: collaborator

Study Sites (1)

University of California, San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 30638635 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Stacey Kenfield, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 12, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: March 1, 2018
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

US (1)