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

20. februar 2019 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

76

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • San Francisco, California, Forente stater, 94143
        • University of California, San Francisco (UCSF)

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fitbit use
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months
We will assess intervention acceptability via questionnaire at 3 months in the intervention group.
3 months
self-reported change in health behaviors
Tidsramme: 3 months
We will assess change in health behaviors via questionnaire at baseline and 3 months.
3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
change in physical activity measured by activity monitor
Tidsramme: 3 months
This is assessed via 7-day accelerometer measurements at baseline and 3 months.
3 months
change in task self-efficacy
Tidsramme: 3 months
We will assess confidence in performing behaviors via questionnaire at baseline and 3 months.
3 months
change in plasma antioxidant Vitamin E
Tidsramme: 3 months
We will assess Vitamin E levels at baseline and 3 months.
3 months
change in plasma antioxidant lycopene
Tidsramme: 3 months
We will assess lycopene levels at baseline and 3 months.
3 months
change in fasting glucose
Tidsramme: 3 months
We will assess fasting glucose at baseline and 3 months.
3 months
change in cholesterol
Tidsramme: 3 months
We will assess cholesterol at baseline and 3 months.
3 months
change in hemoglobin A1c
Tidsramme: 3 months
We will assess hemoglobin A1c at baseline and 3 months.
3 months
change in C-reactive protein
Tidsramme: 3 months
We will assess C-reactive protein at baseline and 3 months.
3 months
change in waist circumference
Tidsramme: 3 months
We will assess waist circumference at baseline and 3 months.
3 months
change in weight
Tidsramme: 3 months
We will assess weight at baseline and 3 months.
3 months
change in body mass index
Tidsramme: 3 months
We will assess body mass index at baseline and 3 months.
3 months
depression
Tidsramme: 3 months
Center for Epidemiologic Studies Depression Scale completed at baseline and 3 months.
3 months
anxiety
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year
We will assess change in health behaviors via questionnaire at baseline, 3 months, and 1 year.
1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, San Francisco

Samarbeidspartnere

American Cancer Society, Inc.
Prostate Cancer Foundation

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2015

Primær fullføring (Faktiske)

1. juni 2017

Studiet fullført (Faktiske)

1. mars 2018

Datoer for studieregistrering

Først innsendt

10. juni 2015

Først innsendt som oppfylte QC-kriteriene

11. juni 2015

Først lagt ut (Anslag)

12. juni 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. februar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. februar 2019

Sist bekreftet

1. februar 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 14-13555

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