VOICE: Values and Options in Cancer Care (VOICE)
8 janvier 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
485
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New York
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Rochester, New York, États-Unis, 14642
- University of Rochester
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Aucune intervention: Control
Patients will receive usual care
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Patient-centered Communication in Advanced Cancer Score
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
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7 months
|
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Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ronald Epstein, MD, University of Rochester
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 avril 2011
Achèvement primaire (Réel)
31 décembre 2017
Achèvement de l'étude (Réel)
31 décembre 2017
Dates d'inscription aux études
Première soumission
30 novembre 2011
Première soumission répondant aux critères de contrôle qualité
2 décembre 2011
Première publication (Estimation)
5 décembre 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 janvier 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 janvier 2019
Dernière vérification
1 janvier 2019
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 35388
- R01CA140419-01A2 (Subvention/contrat des NIH des États-Unis)
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