VOICE: Cancer Communication Study

This study is currently recruiting participants.

Verified September 2012 by University of Rochester

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

University of Rochester

ClinicalTrials.gov Identifier:

NCT01485627

First received: November 30, 2011

Last updated: September 12, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2011

Last Updated Date

September 12, 2012

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Treatment Intent and Prognosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Investigators will assess patient question-asking, assertive responses and expressions of concern.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01485627 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Patient and Caregiver well-being [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Investigators will assess patient and caregiver perceived happiness, well-being, and overall sense of peace.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

VOICE: Cancer Communication Study

Official Title ^ICMJE

RCT of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer

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.

Detailed Description

The purpose of this study is to (a) determine whether a combined intervention for patients, caregivers and physicians improves communication regarding prognosis and treatment choices in advanced 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

Condition ^ICMJE

Cancer

Intervention ^ICMJE

Behavioral: Coaching

Patients will be coached to make the most of the oncologist visit.

Study Arm (s)

Experimental: Intervention
Patients will be coached to make the most of the oncologist visit.

Intervention: Behavioral: Coaching
No Intervention: Control
Patients will receive usual care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

470

Estimated Completion Date

August 2015

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sandy Plumb	585-506-9484 ext 208	sandy_plumb@urmc.rochester.edu
Contact: Ronald Epstein, MD	585-506-9484	ronald_epstein@urmc.rochester.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01485627

Other Study ID Numbers ^ICMJE

35388, 1R01CA140419-01A2

Has Data Monitoring Committee

Yes

Responsible Party

University of Rochester

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Ronald Epstein, MD

University of Rochester

Information Provided By

University of Rochester

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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