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

20 februari 2019 uppdaterad av: University of California, San Francisco

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

76

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • San Francisco, California, Förenta staterna, 94143
        • University of California, San Francisco (UCSF)

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fitbit use
Tidsram: 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
3 months
text message use
Tidsram: 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 months
website use - number of days the website was visited
Tidsram: 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
3 months
website use - number of website visits
Tidsram: 3 months
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
Tidsram: 3 months
We will assess intervention acceptability via questionnaire at 3 months in the intervention group.
3 months
self-reported change in health behaviors
Tidsram: 3 months
We will assess change in health behaviors via questionnaire at baseline and 3 months.
3 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
change in physical activity measured by activity monitor
Tidsram: 3 months
This is assessed via 7-day accelerometer measurements at baseline and 3 months.
3 months
change in task self-efficacy
Tidsram: 3 months
We will assess confidence in performing behaviors via questionnaire at baseline and 3 months.
3 months
change in plasma antioxidant Vitamin E
Tidsram: 3 months
We will assess Vitamin E levels at baseline and 3 months.
3 months
change in plasma antioxidant lycopene
Tidsram: 3 months
We will assess lycopene levels at baseline and 3 months.
3 months
change in fasting glucose
Tidsram: 3 months
We will assess fasting glucose at baseline and 3 months.
3 months
change in cholesterol
Tidsram: 3 months
We will assess cholesterol at baseline and 3 months.
3 months
change in hemoglobin A1c
Tidsram: 3 months
We will assess hemoglobin A1c at baseline and 3 months.
3 months
change in C-reactive protein
Tidsram: 3 months
We will assess C-reactive protein at baseline and 3 months.
3 months
change in waist circumference
Tidsram: 3 months
We will assess waist circumference at baseline and 3 months.
3 months
change in weight
Tidsram: 3 months
We will assess weight at baseline and 3 months.
3 months
change in body mass index
Tidsram: 3 months
We will assess body mass index at baseline and 3 months.
3 months
depression
Tidsram: 3 months
Center for Epidemiologic Studies Depression Scale completed at baseline and 3 months.
3 months
anxiety
Tidsram: 3 months
Memorial Anxiety Scale for Prostate Cancer and State Anxiety completed at baseline and 3 months. Trait anxiety completed at baseline.
3 months
health-related quality of life
Tidsram: 3 months
Expanded Prostate Cancer Index Composite-26 and Short Form Health Survey-36 completed at baseline and 3 months.
3 months
maintenance or adoption of self-reported behaviors after 1 year
Tidsram: 1 year
We will assess change in health behaviors via questionnaire at baseline, 3 months, and 1 year.
1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of California, San Francisco

Samarbetspartners

American Cancer Society, Inc.
Prostate Cancer Foundation

Utredare

  • Huvudutredare: Stacey Kenfield, ScD, University of California, San Francisco

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2015

Primärt slutförande (Faktisk)

1 juni 2017

Avslutad studie (Faktisk)

1 mars 2018

Studieregistreringsdatum

Först inskickad

10 juni 2015

Först inskickad som uppfyllde QC-kriterierna

11 juni 2015

Första postat (Uppskatta)

12 juni 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 februari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 februari 2019

Senast verifierad

1 februari 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 14-13555

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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