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VOICE: Values and Options in Cancer Care (VOICE)

8. januar 2019 oppdatert av: Ronald Epstein, University of Rochester

Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer

The purpose of this study is to determine whether a combined intervention for patients, caregivers and oncologists improves communication, quality of life, and quality of care.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The purpose of this study is to (a) determine whether a combined intervention for patients, caregivers and physicians improves communication regarding treatment choices and prognosis in cancer, (b) to determine whether the intervention improves patient and caregiver well-being, quality of life and sense of peace, and (c) to determine whether the intervention affects health services utilization.

Studietype

Intervensjonell

Registrering (Faktiske)

485

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
    • New York
      • Rochester, New York, Forente stater, 14642
        • University of Rochester

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

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria: Physicians

  • Currently in clinical practice at participating institutions
  • Oncologist that cares for patients with solid tumors
  • Not planning to leave the practice during the next 6 months

Inclusion Criteria: Patients

  • Currently a patient of an enrolled physician
  • Age 21 years or older
  • Diagnosis of advanced cancer
  • Able to understand spoken English (study personnel will read materials to low literacy patients)

Inclusion Criteria: Caregivers

  • Caregiver of a patient currently enrolled in the study
  • Age 21 years or older
  • Able to understand spoken English (study personnel will read materials to low literacy patients)

Exclusion Criteria: Physicians

  • Non Physicians and physicians who are not oncologists
  • Oncologists who exclusively care for patients with hematological malignancies
  • Prior involvement in health-related coaching interventions

Exclusion Criteria: Patients

  • Unable to complete orally-administered surveys in English
  • Hospitalized or in hospice care at the time of recruitment
  • Prior involvement in health-related coaching interventions
  • Anticipating bone marrow transplantation or diagnosed with leukemia or lymphoma

Exclusion Criteria: Caregiver

Unable to complete orally-administered surveys in English

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention
Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
Atferdsmessig: Communication training and coaching
Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
Ingen inngripen: Control
Patients will receive usual care

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Patient-centered Communication in Advanced Cancer Score
Tidsramme: 3 years
We audio recorded the first physician visit after the coaching session (for intervention) or after study entry (control).The primary outcome was a composite of 4 pre-specified communication measures: 1. engaging patients in consultations, responding to patients' emotions, informing patients about prognosis and treatment choices and balanced framing of decisions. Coding of the 4 measures was performed by teams of trained university students who were audited continuously and blinded to study hypotheses and group assignment. We transformed each of the 4 component scores to z scores based on the pre-randomization phase sample means (SDs): z = (Raw Score - Pre-randomization Phase Mean)/Pre-randomization Phase SD. The 4-component z-scores were averaged to form the primary outcome. A higher Z score indicates better communication. The maximum possible Z-score ranged from -0.69 to 20.08.
3 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13
Tidsramme: 7 months
The prolonged grief (PG-13) instrument was used to measure prolonged grief. The tool is a sum of ten items that measure separation distress, duration of grief, cognitive, emotional, and behavioral symptoms and impairment criterion. The range of the score is 10-50 with higher scores indicating more severe symptoms.
7 months
Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians
Tidsramme: 3 years
Patients and physicians were asked what the likelihood of survival in 2 years would be for the patient. They chose from 0, 10, 25, 50, 75, 90, 100% chance of survival in two years. A value of 0-6 was assigned to each pair of data. 0 indicating no difference in the reported value between patient and physician and 6 indicating the largest difference. For example if the physician said 100% and the patient said 0% the score was 6. The mean scores were reported by arm.
3 years
Aim 2 Patient Well-being
Tidsramme: 3 years
Original McGill quality of life and the FACT-G assessment tools were used. For the McGill tool scores range from 1 to 10 with higher scores indicating better outcome. For FACT-G scores range from 0 to 4. Higher score means a better outcome. Different parts of the McGill and FACT-G tools were used to create 5 standardized z scores: McGill QOL Scale single item, McGill Psychological Well-Being sub-scale, McGill Existential Well-Being sub-scale, FACT-G Physical Functioning sub-scale and FACT-G Social Functioning sub-scale. Sum of the five standardized z-scores is the Aggregate QOL score. A higher Z score indicates better outcomes. The maximum possible Z-score ranged from -3.54 to 1.24.
3 years
Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment
Tidsramme: 7 months
SF-12 scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
7 months
Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life
Tidsramme: 3 years
Patient charts were audited for 3 outcomes : 1) chemotherapy use, 2) aggressive treatments and 3) emergency department or hospital utilization. The total scores ranged from 0-6 with higher scores indicated worse outcomes. The sums of the means for the 3 outcomes were added to provide the total score.
3 years

Samarbeidspartnere og etterforskere

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

Sponsor

University of Rochester

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Ronald Epstein, MD, University of Rochester

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. april 2011

Primær fullføring (Faktiske)

31. desember 2017

Studiet fullført (Faktiske)

31. desember 2017

Datoer for studieregistrering

Først innsendt

30. november 2011

Først innsendt som oppfylte QC-kriteriene

2. desember 2011

Først lagt ut (Anslag)

5. desember 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 35388
  • R01CA140419-01A2 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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