VOICE: Values and Options in Cancer Care

NCT01485627 | Completed Results DMC

• 2 other identifiers: 35388R01CA140419-01A2
• Study Type: interventional
• Target: 485
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Cancer; Communication; prognosis

Outcome Measures

Primary Outcomes (1)

• Mean Patient-centered Communication in Advanced Cancer Score

  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

Secondary Outcomes (5)

• Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13

  7 months

• Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians

  3 years

• Aim 2 Patient Well-being

  3 years

• Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment

  7 months

• Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life

  3 years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Communication training and coaching

Control

NO INTERVENTION

Patients will receive usual care

Interventions

Communication training and coaching BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

• 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.

  PMID: 27612178 DERIVED

• 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.

  PMID: 23570278 DERIVED

MeSH Terms

Conditions

Neoplasms; Communication

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

This was a study of terminally ill patients and all deaths were expected.

Results Point of Contact

• Title: Ronald Epstein MD
• Organization: UNIVERSITY OF ROCHESTER DEPARTMENT OF FAMILY MEDICINE

ronald_epstein@urmc.rochester.edu

5855069484

Study Officials

• Ronald Epstein, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 5, 2011
• Study Start: April 1, 2011
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 10, 2019
• Results First Posted: January 10, 2019

Record last verified: 2019-01

Locations

US (1)