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A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer

7. maj 2019 opdateret af: Case Comprehensive Cancer Center

A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer

Participants are asked to participate in a research study of the effect of a sleep intervention on improving sleep habits and reducing their risk of breast cancer.

Participants are asked to participate in this research study because they have been identified as being at higher than average risk of developing breast cancer.

The purpose of this study is to compare women who get a sleep intervention to women who do not get a sleep intervention. This study team will compare these two groups of women to see if the sleep intervention improves their sleep and if it lowers markers of inflammation that have been associated with an increased risk of breast cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Objective 1: To test the effectiveness of the GO! To Sleep program at improving the sleep duration and sleep quality in women at high risk of breast cancer.

Objective 2: To test the effectiveness of improvements in sleep quality and/or duration due to the GO! To Sleep program on biomarkers of inflammation in women at high risk of breast cancer.

Objective 3: To evaluate the effectiveness of improvements in health-related quality of life after the GO! To Sleep in women at high risk of breast cancer.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

17

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
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. Women at high risk of breast cancer due to one or more of the following:

    • Carry deleterious mutations in the BRCA1, BRCA2, PTEN, TP53, STK11, or CDH1 genes
    • Previous diagnosis of lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH) or atypical lobular hyperplasia (ALH)
    • Lifetime risk of 20% or greater as calculated by the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool or the Tyrer-Cuzick IBIS Risk Assessment Tool
  2. Ability to access the internet and watch videos online.
  3. Valid email address.
  4. Self-reported sleep duration of 6 hours per night or less

Exclusion Criteria:

  1. Previous diagnosis of cancer.
  2. Lack of ability to read and converse in English.
  3. Lack of ability to give informed consent.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GO! To Sleep
Participants in the intervention group will be provided with a code and website address to participate in this program. This program includes reminder emails and is 6 weeks in duration. Participants will be given a blood draw to measure biomarkers.
Adfærdsmæssigt: GO! To Sleep
Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior
Procedure: Blood Draw
blood sample measured for stress and sleep markers
Andre navne:
  • biomarker measurement
Andet: Pittsburgh Sleep Quality Index (PSQI)
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Andet: Insomnia Severity Index (ISI)
Andet: SF-12 quality of life survey
Aktiv komparator: informational control
Participants in the control group will receive weekly emails with sleep information and the health benefits of sleep for 6 weeks.Participants will be given a blood draw to measure biomarkers.
Procedure: Blood Draw
blood sample measured for stress and sleep markers
Andre navne:
  • biomarker measurement
Andet: Pittsburgh Sleep Quality Index (PSQI)
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Andet: Insomnia Severity Index (ISI)
Andet: SF-12 quality of life survey
Adfærdsmæssigt: Sleep information
Participants will receive weekly emails on the health benefits of sleep for 6 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Tidsramme: Change from baseline to post intervention, around 8 weeks after baseline
Sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
Change from baseline to post intervention, around 8 weeks after baseline
Difference in change in Insomnia Severity Index (ISI) score between groups
Tidsramme: Change from baseline to post intervention, around 8 weeks after baseline
Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Change from baseline to post intervention, around 8 weeks after baseline
Difference in change in sleep duration between groups
Tidsramme: Change from baseline to post intervention, around 8 weeks after baseline
Sleep duration will be obtained by self-report from responses to the PSQI
Change from baseline to post intervention, around 8 weeks after baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in change of SF-12 score from baseline to post-intervention between groups
Tidsramme: Change from baseline to 6 months post intervention
The effectiveness of changing health-related quality of life after the GO! To Sleep program will he measured with the self-reported survey SF-12
Change from baseline to 6 months post intervention
Correlation of joint changes in biomarker levels with PSQI and ISI
Tidsramme: Change from baseline to 6 months post intervention
This study will correlate the joint changes in biomarker level with the changes in sleep quality and sleep duration
Change from baseline to 6 months post intervention
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Tidsramme: Change from baseline to 6 months post intervention
Long term sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
Change from baseline to 6 months post intervention
Difference in change in Insomnia Severity Index (ISI) score between groups
Tidsramme: Change from baseline to 6 months post intervention
Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Change from baseline to 6 months post intervention
Difference in change in sleep duration between groups
Tidsramme: Change from baseline to 6 months post intervention
Sleep duration will be obtained by self-report from responses to the PSQI
Change from baseline to 6 months post intervention

Samarbejdspartnere og efterforskere

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

Sponsor

Case Comprehensive Cancer Center

Efterforskere

  • Ledende efterforsker: Cheryl Thompson, PhD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

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)

4. august 2015

Primær færdiggørelse (Faktiske)

23. marts 2017

Studieafslutning (Faktiske)

23. juli 2017

Datoer for studieregistrering

Først indsendt

23. november 2015

Først indsendt, der opfyldte QC-kriterier

23. november 2015

Først opslået (Skøn)

25. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CASE6114

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Kliniske forsøg med Brystkræft

Kliniske forsøg med GO! To Sleep

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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