VOICE: Values and Options in Cancer Care

NCT ID: NCT01485627

Last Updated: 2019-01-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.

Group Type EXPERIMENTAL

Communication training and coaching

Intervention Type BEHAVIORAL

Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.

Control

Patients will receive usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Communication training and coaching

Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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


* 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)


* 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

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


* 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


Unable to complete orally-administered surveys in English
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Ronald Epstein

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald Epstein, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27612178 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23570278 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R01CA140419-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

35388

Identifier Type: -

Identifier Source: org_study_id

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