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Prostate CancerProstate 8NCT02470936

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

A study testing Lifestyle intervention in people with Prostate Cancer, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteUnited States
Study dates
Jun 2015to Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94143

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Lifestyle intervention
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionBehavioural

    Patients will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive texts, and be provided with individualized lifestyle recommendations.

Study groups in NCT02470936
Study groupRoleWhat they receive
Group 1- Lifestyle InterventionExperimentalMen 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.
Receives: Behavioral: Lifestyle intervention
Group 2 - ControlNo interventionMen 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months

  2. 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

    Measured: 3 months

  3. 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

    Measured: 3 months

  4. 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

    Measured: 3 months

  5. intervention acceptability

    We will assess intervention acceptability via questionnaire at 3 months in the intervention group.

    Measured: 3 months

  6. self-reported change in health behaviors

    We will assess change in health behaviors via questionnaire at baseline and 3 months.

    Measured: 3 months

Secondary outcomes (15)

  1. change in physical activity measured by activity monitor

    This is assessed via 7-day accelerometer measurements at baseline and 3 months.

    Measured: 3 months

  2. change in task self-efficacy

    We will assess confidence in performing behaviors via questionnaire at baseline and 3 months.

    Measured: 3 months

  3. change in plasma antioxidant Vitamin E

    We will assess Vitamin E levels at baseline and 3 months.

    Measured: 3 months

  4. change in plasma antioxidant lycopene

    We will assess lycopene levels at baseline and 3 months.

    Measured: 3 months

  5. change in fasting glucose

    We will assess fasting glucose at baseline and 3 months.

    Measured: 3 months

  6. change in cholesterol

    We will assess cholesterol at baseline and 3 months.

    Measured: 3 months

  7. change in hemoglobin A1c

    We will assess hemoglobin A1c at baseline and 3 months.

    Measured: 3 months

  8. change in C-reactive protein

    We will assess C-reactive protein at baseline and 3 months.

    Measured: 3 months

  9. change in waist circumference

    We will assess waist circumference at baseline and 3 months.

    Measured: 3 months

  10. change in weight

    We will assess weight at baseline and 3 months.

    Measured: 3 months

  11. change in body mass index

    We will assess body mass index at baseline and 3 months.

    Measured: 3 months

  12. depression

    Center for Epidemiologic Studies Depression Scale completed at baseline and 3 months.

    Measured: 3 months

  13. anxiety

    Memorial Anxiety Scale for Prostate Cancer and State Anxiety completed at baseline and 3 months. Trait anxiety completed at baseline.

    Measured: 3 months

  14. health-related quality of life

    Expanded Prostate Cancer Index Composite-26 and Short Form Health Survey-36 completed at baseline and 3 months.

    Measured: 3 months

  15. maintenance or adoption of self-reported behaviors after 1 year

    We will assess change in health behaviors via questionnaire at baseline, 3 months, and 1 year.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJun 2017
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02470936
Sponsor's protocol ID
14-13555
Acronym
Prostate 8
Status last verified
Feb 2019
First submitted
10 Jun 2015
Last updated
22 Feb 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30638635

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Prostate Cancer, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fitbit use (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02470936, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.

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