Clinical trial NCT01485627: VOICE: Values and Options in Cancer Care
Official title: Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
Communication
prognosis
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-05
Enrollment: 485
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Patient-centered Communication in Advanced Cancer Score
timeFrame: 3 years
Secondary outcomes:
measure: Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13
timeFrame: 7 months
measure: Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians
timeFrame: 3 years
measure: Aim 2 Patient Well-being
timeFrame: 3 years
measure: Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment
timeFrame: 7 months
measure: Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life
timeFrame: 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Ronald Epstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.