Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

20. februar 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

76

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94143
        • University of California, San Francisco (UCSF)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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 indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Samarbejdspartnere

American Cancer Society, Inc.
Prostate Cancer Foundation

Efterforskere

  • Ledende efterforsker: Stacey Kenfield, ScD, University of California, San Francisco

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2015

Primær færdiggørelse (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. marts 2018

Datoer for studieregistrering

Først indsendt

10. juni 2015

Først indsendt, der opfyldte QC-kriterier

11. juni 2015

Først opslået (Skøn)

12. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14-13555

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lifestyle intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Russia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner