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

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ClinicalTrials.gov Identifier: NCT02470936
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : February 22, 2019
Sponsor:
Collaborators:
American Cancer Society, Inc.
Prostate Cancer Foundation
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Lifestyle intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Clinical Trial of Web-based Lifestyle Tools and Resources Versus Usual Care Among Men With Prostate Cancer
Actual Study Start Date : June 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.



Primary Outcome Measures :
  1. Fitbit use [ Time Frame: 3 months ]
    We will measure the number of days the Fitbit was used during the study period in the intervention arm only to assess study feasibility

  2. text message use [ Time Frame: 3 months ]
    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. website use - number of days the website was visited [ Time Frame: 3 months ]
    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

  4. website use - number of website visits [ Time Frame: 3 months ]
    We will measure the total number of website visits in the intervention arm only during the study period to assess study feasibility

  5. intervention acceptability [ Time Frame: 3 months ]
    We will assess intervention acceptability via questionnaire at 3 months in the intervention group.

  6. self-reported change in health behaviors [ Time Frame: 3 months ]
    We will assess change in health behaviors via questionnaire at baseline and 3 months.


Secondary Outcome Measures :
  1. change in physical activity measured by activity monitor [ Time Frame: 3 months ]
    This is assessed via 7-day accelerometer measurements at baseline and 3 months.

  2. change in task self-efficacy [ Time Frame: 3 months ]
    We will assess confidence in performing behaviors via questionnaire at baseline and 3 months.

  3. change in plasma antioxidant Vitamin E [ Time Frame: 3 months ]
    We will assess Vitamin E levels at baseline and 3 months.

  4. change in plasma antioxidant lycopene [ Time Frame: 3 months ]
    We will assess lycopene levels at baseline and 3 months.

  5. change in fasting glucose [ Time Frame: 3 months ]
    We will assess fasting glucose at baseline and 3 months.

  6. change in cholesterol [ Time Frame: 3 months ]
    We will assess cholesterol at baseline and 3 months.

  7. change in hemoglobin A1c [ Time Frame: 3 months ]
    We will assess hemoglobin A1c at baseline and 3 months.

  8. change in C-reactive protein [ Time Frame: 3 months ]
    We will assess C-reactive protein at baseline and 3 months.

  9. change in waist circumference [ Time Frame: 3 months ]
    We will assess waist circumference at baseline and 3 months.

  10. change in weight [ Time Frame: 3 months ]
    We will assess weight at baseline and 3 months.

  11. change in body mass index [ Time Frame: 3 months ]
    We will assess body mass index at baseline and 3 months.

  12. depression [ Time Frame: 3 months ]
    Center for Epidemiologic Studies Depression Scale completed at baseline and 3 months.

  13. anxiety [ Time Frame: 3 months ]
    Memorial Anxiety Scale for Prostate Cancer and State Anxiety completed at baseline and 3 months. Trait anxiety completed at baseline.

  14. health-related quality of life [ Time Frame: 3 months ]
    Expanded Prostate Cancer Index Composite-26 and Short Form Health Survey-36 completed at baseline and 3 months.

  15. maintenance or adoption of self-reported behaviors after 1 year [ Time Frame: 1 year ]
    We will assess change in health behaviors via questionnaire at baseline, 3 months, and 1 year.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470936


Locations
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United States, California
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
American Cancer Society, Inc.
Prostate Cancer Foundation
Investigators
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Principal Investigator: Stacey Kenfield, ScD University of California, San Francisco

Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02470936     History of Changes
Other Study ID Numbers: 14-13555
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases