VOICE: Values and Options in Cancer Care

Cancer Clinical Trial

— VOICE  

Official title:

Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485627
• Other study ID #: 35388
• Secondary ID: R01CA140419-01A2
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Communication training and coaching
Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13	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.	7 months
Secondary	Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians	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.	3 years
Secondary	Aim 2 Patient Well-being	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.	3 years
Secondary	Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment	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.	7 months
Secondary	Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life	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.	3 years