Web-based Lifestyle Trial Among Men With Prostate Cancer: Prostate 8 (Prostate 8)
20 februari 2019 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
76
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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San Francisco, California, Verenigde Staten, 94143
- University of California, San Francisco (UCSF)
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Patients will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive texts, and be provided with individualized lifestyle recommendations.
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Geen tussenkomst: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Fitbit use
Tijdsspanne: 3 months
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We will measure the number of days the Fitbit was used during the study period in the intervention arm only to assess study feasibility
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3 months
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text message use
Tijdsspanne: 3 months
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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
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3 months
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website use - number of days the website was visited
Tijdsspanne: 3 months
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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
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3 months
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website use - number of website visits
Tijdsspanne: 3 months
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We will measure the total number of website visits in the intervention arm only during the study period to assess study feasibility
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3 months
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intervention acceptability
Tijdsspanne: 3 months
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We will assess intervention acceptability via questionnaire at 3 months in the intervention group.
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3 months
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self-reported change in health behaviors
Tijdsspanne: 3 months
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We will assess change in health behaviors via questionnaire at baseline and 3 months.
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3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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change in physical activity measured by activity monitor
Tijdsspanne: 3 months
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This is assessed via 7-day accelerometer measurements at baseline and 3 months.
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3 months
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change in task self-efficacy
Tijdsspanne: 3 months
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We will assess confidence in performing behaviors via questionnaire at baseline and 3 months.
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3 months
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change in plasma antioxidant Vitamin E
Tijdsspanne: 3 months
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We will assess Vitamin E levels at baseline and 3 months.
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3 months
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change in plasma antioxidant lycopene
Tijdsspanne: 3 months
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We will assess lycopene levels at baseline and 3 months.
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3 months
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change in fasting glucose
Tijdsspanne: 3 months
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We will assess fasting glucose at baseline and 3 months.
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3 months
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change in cholesterol
Tijdsspanne: 3 months
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We will assess cholesterol at baseline and 3 months.
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3 months
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change in hemoglobin A1c
Tijdsspanne: 3 months
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We will assess hemoglobin A1c at baseline and 3 months.
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3 months
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change in C-reactive protein
Tijdsspanne: 3 months
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We will assess C-reactive protein at baseline and 3 months.
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3 months
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change in waist circumference
Tijdsspanne: 3 months
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We will assess waist circumference at baseline and 3 months.
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3 months
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change in weight
Tijdsspanne: 3 months
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We will assess weight at baseline and 3 months.
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3 months
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change in body mass index
Tijdsspanne: 3 months
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We will assess body mass index at baseline and 3 months.
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3 months
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depression
Tijdsspanne: 3 months
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Center for Epidemiologic Studies Depression Scale completed at baseline and 3 months.
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3 months
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anxiety
Tijdsspanne: 3 months
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Memorial Anxiety Scale for Prostate Cancer and State Anxiety completed at baseline and 3 months.
Trait anxiety completed at baseline.
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3 months
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health-related quality of life
Tijdsspanne: 3 months
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Expanded Prostate Cancer Index Composite-26 and Short Form Health Survey-36 completed at baseline and 3 months.
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3 months
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maintenance or adoption of self-reported behaviors after 1 year
Tijdsspanne: 1 year
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We will assess change in health behaviors via questionnaire at baseline, 3 months, and 1 year.
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1 year
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Stacey Kenfield, ScD, University of California, San Francisco
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juni 2015
Primaire voltooiing (Werkelijk)
1 juni 2017
Studie voltooiing (Werkelijk)
1 maart 2018
Studieregistratiedata
Eerst ingediend
10 juni 2015
Eerst ingediend dat voldeed aan de QC-criteria
11 juni 2015
Eerst geplaatst (Schatting)
12 juni 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 februari 2019
Laatste update ingediend die voldeed aan QC-criteria
20 februari 2019
Laatst geverifieerd
1 februari 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 14-13555
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