VOICE: Values and Options in Cancer Care (VOICE)
8 gennaio 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
485
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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New York
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Rochester, New York, Stati Uniti, 14642
- University of Rochester
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
21 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Intervention
Oncologists will receive communication training.
Patients will be coached to make the most of the oncologist visit.
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Oncologists will receive communication training.
Patients will be coached to make the most of the oncologist visit.
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Nessun intervento: Control
Patients will receive usual care
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mean Patient-centered Communication in Advanced Cancer Score
Lasso di tempo: 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.
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3 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13
Lasso di tempo: 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.
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7 months
|
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Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians
Lasso di tempo: 3 years
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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.
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3 years
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Aim 2 Patient Well-being
Lasso di tempo: 3 years
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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.
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3 years
|
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Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment
Lasso di tempo: 7 months
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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.
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7 months
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Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life
Lasso di tempo: 3 years
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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.
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3 years
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Ronald Epstein, MD, University of Rochester
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Epstein RM, Duberstein PR, Fenton JJ, Fiscella K, Hoerger M, Tancredi DJ, Xing G, Gramling R, Mohile S, Franks P, Kaesberg P, Plumb S, Cipri CS, Street RL Jr, Shields CG, Back AL, Butow P, Walczak A, Tattersall M, Venuti A, Sullivan P, Robinson M, Hoh B, Lewis L, Kravitz RL. Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer: The VOICE Randomized Clinical Trial. JAMA Oncol. 2017 Jan 1;3(1):92-100. doi: 10.1001/jamaoncol.2016.4373.
- Hoerger M, Epstein RM, Winters PC, Fiscella K, Duberstein PR, Gramling R, Butow PN, Mohile SG, Kaesberg PR, Tang W, Plumb S, Walczak A, Back AL, Tancredi D, Venuti A, Cipri C, Escalera G, Ferro C, Gaudion D, Hoh B, Leatherwood B, Lewis L, Robinson M, Sullivan P, Kravitz RL. Values and options in cancer care (VOICE): study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers. BMC Cancer. 2013 Apr 9;13:188. doi: 10.1186/1471-2407-13-188.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 aprile 2011
Completamento primario (Effettivo)
31 dicembre 2017
Completamento dello studio (Effettivo)
31 dicembre 2017
Date di iscrizione allo studio
Primo inviato
30 novembre 2011
Primo inviato che soddisfa i criteri di controllo qualità
2 dicembre 2011
Primo Inserito (Stima)
5 dicembre 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 gennaio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 gennaio 2019
Ultimo verificato
1 gennaio 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 35388
- R01CA140419-01A2 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .