VOICE: Values and Options in Cancer Care

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT01485627
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 485
• Location: 1
• Arms: 2
• Actual Duration (Months): 81
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Communication training and coaching	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 485 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer
• Actual Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.	Behavioral: Communication training and coaching; Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
No Intervention: Control Patients will receive usual care

Outcome Measures

Primary Outcome Measures

1. Mean Patient-centered Communication in Advanced Cancer Score [3 years]

   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.

Secondary Outcome Measures

1. Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13 [7 months]

   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.

2. Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians [3 years]

   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. Aim 2 Patient Well-being [3 years]

   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.

4. Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment [7 months]

   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.

5. Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life [3 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Ronald Epstein, MD, University of Rochester

Study Documents (Full-Text)

• Study Protocol - Feb 20, 2016
• Statistical Analysis Plan - Mar 12, 2016

More Information

Publications

None provided.

• Responsible Party: Ronald Epstein, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01485627
• Other Study ID Numbers: 35388; R01CA140419-01A2
• First Posted: Dec 5, 2011
• Last Update Posted: Jan 10, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Ronald Epstein, Professor, University of Rochester: Cancer; Communication; prognosis

Study Results

Participant Flow

Recruitment Details	54 physicians were assessed for eligibility. Of these 2 were ineligible and 9 refused participation. 43 physicians were included in the pre-randomized phase and of these 2 withdrew and 3 did not enroll enough patients. Patients from 38 physicians were included for the cluster randomized clinical trial phase of the study.
Pre-assignment Detail	233 caregivers and 316 patients were consented. 204 caregivers were allocated and 127 of them were bereaved. 24 caregivers failed screening and 5 withdrew during screening. 26 patients failed screening and 9 withdrew during screening.

Arm/Group Title	Intervention: Communication	Control: Usual Care
Arm/Group Description	Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.	Patients will receive usual care
Period Title: Overall Study
STARTED	244	241
Allocated Caregivers: Total	105	99
Bereaved Caregivers: Total	63	64
Bereaved Caregivers: 1 Month	51	51
Bereaved Caregivers: 2 Month Completed	49	52
Bereaved Caregivers: 7 Month Completed	48	49
COMPLETED	178	184
NOT COMPLETED	66	57

Baseline Characteristics

Arm/Group Title	Intervention: Communication Training	Control: Usual Care	Total
Arm/Group Description	Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.	Patients will receive usual care	Total of all reporting groups
Overall Participants	180	188	368
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	21 11.7%	27 14.4%	48 13%
>=65 years	29 16.1%	26 13.8%	55 14.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.2 (11.7)	64.5 (11)	64.4 (11.4)
Sex: Female, Male (Count of Participants)
Female	76 42.2%	70 37.2%	146 39.7%
Male	54 30%	65 34.6%	119 32.3%
Female	25 13.9%	29 15.4%	54 14.7%
Male	25 13.9%	24 12.8%	49 13.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	116 64.4%	119 63.3%	235 63.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	14 7.8%	16 8.5%	30 8.2%
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	44 24.4%	46 24.5%	90 24.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	6 3.3%	7 3.7%	13 3.5%
Region of Enrollment (participants) [Number]
United States	130 72.2%	135 71.8%	265 72%
Region of Enrollment (participants) [Number]
United States	50 27.8%	53 28.2%	103 28%

Outcome Measures

1. Primary Outcome

Title	Mean Patient-centered Communication in Advanced Cancer Score
Description	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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

This outcome measure was assessed in patients only.

Arm/Group Title	Intervention	Control
Arm/Group Description	Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.	Patients will receive usual care
Measure Participants	130	135
Mean (Standard Deviation) [standardized score on a scale]	0.16 (0.81)	-0.01 (0.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments	The primary outcome was a composite of 4 prespecified communication measures matched to the goals of communication training, as follows: Active Patient Participation Coding [APPC], Verona VR-CoDES, Prognostic and Treatment Choices [PTCC] Informing subscale, and PTCC Balanced Framing subscale. The 4 measures were z-score transformed and averaged to produce the composite measure.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Adjusted mean difference in difference
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95%; 0.06 to 0.62
	Parameter Dispersion	Type: Value:
	Estimation Comments	Models included fixed-effects terms for phase (pre- vs postrandomization), study arm, and the Phase*Arm interaction. Estimated effect is the between-arm difference in adjusted mean difference from prerandomization to postrandomization samples.

2. Secondary Outcome

Title	Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13
Description	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.
Time Frame	7 months

Outcome Measure Data

Analysis Population Description

This instrument was used with caregivers only.

Arm/Group Title	Intervention: Communication	Control: Usual Care
Arm/Group Description	Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.	Patients will receive usual care
Measure Participants	48	49
Mean (Standard Deviation) [units on a scale]	19.3 (5.9)	20.6 (6.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.214
	Comments
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians
Description	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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

This outcome measure was assessed in patients only.

Arm/Group Title	Intervention	Control
Arm/Group Description	Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.	Patients will receive usual care
Measure Participants	130	135
Mean (Standard Deviation) [units on a scale]	2.2 (1.5)	2.5 (1.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95%; -0.56 to 0.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Aim 2 Patient Well-being
Description	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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

This outcome measure was assessed in patients only.

Arm/Group Title	Intervention: Communication	Control: Usual Care
Arm/Group Description	Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.	Patients will receive usual care
Measure Participants	130	135
Mean (Standard Deviation) [standardized score on a scale]	-0.01 (0.73)	-0.07 (0.80)

5. Secondary Outcome

Title	Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment
Description	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.
Time Frame	7 months

Outcome Measure Data

Analysis Population Description

Sf-12 was given to the caregivers only.

Arm/Group Title	Intervention: Communication	Control: Usual Care
Arm/Group Description	Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.	Patients will receive usual care
Measure Participants	48	49
Mean (Standard Deviation) [units on a scale]	48.9 (9.6)	47.9 (11.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.677
	Comments
	Method	Mixed Models Analysis
	Comments

6. Secondary Outcome

Title	Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life
Description	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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Health care utilization was assessed in patients only.

Arm/Group Title	Intervention	Control
Arm/Group Description	Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.	Patients will receive usual care
Measure Participants	130	135
Mean (Standard Deviation) [units on a scale]	0.76 (1.1)	0.58 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	3 years
Adverse Event Reporting Description	There were 91 deaths in the intervention arm for the patients and 1 caregiver death. These were terminally ill patients. Adverse events were not collected for the physicians.
Arm/Group Title	Intervention-patients		Control-patients		Intervention- Caregivers		Intervention-caregivers
Arm/Group Description	Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.		Patients will receive usual care		Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.		Patients will receive usual care
All Cause Mortality
	Intervention-patients		Control-patients		Intervention- Caregivers		Intervention-caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	91/139 (65.5%)		96/142 (67.6%)		1/105 (1%)		0/99 (0%)
Serious Adverse Events
	Intervention-patients		Control-patients		Intervention- Caregivers		Intervention-caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/139 (0%)		0/142 (0%)		0/105 (0%)		0/99 (0%)
Other (Not Including Serious) Adverse Events
	Intervention-patients		Control-patients		Intervention- Caregivers		Intervention-caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/139 (0%)		0/142 (0%)		0/105 (0%)		0/99 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.