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Four Conversations RCT

12. desember 2018 oppdatert av: Duke University

Four Conversations Randomized Controlled Trial

The purpose of this study is to see whether patients with metastatic breast cancer, their caregivers, and their healthcare providers can improve in shared decision making (SDM) and preparedness around end of life (EOL) planning through participation in Reimagine's online Four Conversations™ program. The goal is to close clinical practice gaps and enhance the quality of care for patients with metastatic breast cancer through increased competence and performance of healthcare providers and healthcare systems.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

357

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
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center

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

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosed with metastatic breast cancer (MBC), caregiver to patient with MBC who is enrolled in this study, or MBC provider
  • Age ≥ 18 years
  • Internet access through a computer, laptop, tablet, or other mobile device
  • Able/willing to have an online interaction with a Reimagine Pillar Guide
  • Providing informed consent
  • Able to read/write English

Exclusion Criteria:

- None

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: Four Conversations Intervention
Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks.
Atferdsmessig: Four Conversations
The online Four Conversations program consists of tutorial videos, printable documents, and live sessions with a counselor to educate subjects on shared decision making and care planning for those with advanced disease.
Annen: Waitlisted Control
Subjects in this arm will continue to receive standard care from their healthcare providers during the initial study period (i.e. no intervention). After four weeks, subjects will then participate in Reimagine's online Four Conversations program.
Atferdsmessig: Four Conversations
The online Four Conversations program consists of tutorial videos, printable documents, and live sessions with a counselor to educate subjects on shared decision making and care planning for those with advanced disease.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in patient/caregiver and provider preparedness for decision making as measured by the Preparation for Decision Making Scale
Tidsramme: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
The Preparation for Decision Making Scale is a reliable and validated self-reported measure of the patient/caregiver or provider's perception of how useful a decision support intervention is in preparing the respondent to communicate with others making a health decision. Items are summed and scored, then divided by 10; scores can be converted to a 0-100 scale. Higher scores indicate higher perceived level of preparation for decision making.
Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Change in patient/caregiver decision making self-efficacy as measured by the Decision Self-efficacy Scale
Tidsramme: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
The Decision Self-efficacy Scale is a reliable and validated instrument that measures self-confidence or belief in one's abilities in decision making, including shared decision making (SDM). Items are summed, divided by 11, and multiplied by 25. Scores range from 0 to 100 (very confident).
Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Change in patient self-conflict as measured by the Decisional Conflict Scale
Tidsramme: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
The Decisional Conflict scale is a reliable and validated measure of the state of uncertainty about a course of action. Items are summed, divided by 16, and multiplied by 25. Scores range from 0 to 100 (high decisional conflict).
Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment
Tidsramme: Baseline, Post-Intervention (Week 4)
The content of the City of Hope End of Life Knowledge Assessment was revised to reflect the program curriculum. Correctly answered questions will be awarded one point, summed, and a total score generated.
Baseline, Post-Intervention (Week 4)
Change in patient and caregiver quality of life (QOL) as measured by the PROMIS Global Scale
Tidsramme: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
The PROMIS Global Scale is a reliable and validated measure of general perceptions of health. Items are predictive of care utilization and mortality. The scale produces two health scores: physical and mental. Items are summed and converted to t-scores.
Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Change in patient/caregiver and provider end of life (EOL) conversations as measured by EOL Conversations
Tidsramme: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
The EOL Conversations are author-developed questionnaires incorporating items from the Survey on Advanced Care Planning Conversations. Points are totaled and summed.
Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility as measured by completion of advance directive documents
Tidsramme: Post-Intervention (Week 4 or 8)
Post-Intervention (Week 4 or 8)
Feasibility as measured by the patient's completion of Reimagine's Worries to Wishes Treatment Plan
Tidsramme: Post-Intervention (Week 4 or 8)
Post-Intervention (Week 4 or 8)
Feasibility as measured by Reimagine's Four Conversations program usage, as measured by clickstream data from Reimagine's website and Reimagine staff report
Tidsramme: Intervention period (4 weeks)
Clickstream data associated with viewing videos and other web content (e.g., social community) on the Reimagine website will be collected and analyzed through a web analytics software package. Session attendance will be collected by the Reimagine staff (specially trained counselors called Pillar Guides) and sent to the study team for analysis following each of the online meetings.
Intervention period (4 weeks)
Feasibility as measured by satisfaction with Reimagine's Four Conversations program, as measured by the Program Satisfaction & Evaluation questionnaire
Tidsramme: Post-Intervention (Week 4 or 8)
The Program Satisfaction & Evaluation questionnaire was developed by the study team to assess perceived helpfulness of the program in terms of outcomes and patient-provider communication. Points are totaled and summed.
Post-Intervention (Week 4 or 8)

Samarbeidspartnere og etterforskere

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

Sponsor

Duke University

Samarbeidspartnere

Pfizer
National Comprehensive Cancer Network
Duke Cancer Institute
Pillars4Life, Inc.

Etterforskere

  • Hovedetterforsker: Sophia K Smith, PhD, Duke University School of Nursing

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)

15. desember 2016

Primær fullføring (Faktiske)

21. oktober 2018

Studiet fullført (Faktiske)

21. oktober 2018

Datoer for studieregistrering

Først innsendt

24. oktober 2016

Først innsendt som oppfylte QC-kriteriene

24. oktober 2016

Først lagt ut (Anslag)

25. oktober 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. desember 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. desember 2018

Sist bekreftet

1. desember 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pro00070790

Plan for individuelle deltakerdata (IPD)

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NEI

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