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Completed

NCT Number: NCT02470936

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco (UCSF)

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • American Cancer Society, Inc.
  • Prostate Cancer Foundation

Registry information

Official study title

A Randomized Clinical Trial of Web-based Lifestyle Tools and Resources Versus Usual Care Among Men With Prostate Cancer

Acronym: Prostate 8

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 12, 2015
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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