Cancer
Conditions
Keywords
Cancer, Communication, prognosis
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.
Interventions
BEHAVIORALCommunication training and coaching
Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
Sponsors
National Cancer Institute (NCI)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention: Communication Training 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. | 180 |
| Control: Usual Care Patients will receive usual care | 188 |
| Total | 368 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Caregiver died | 1 | 0 |
| Overall Study | Caregiver lost to follow up | 11 | 12 |
| Overall Study | caregiver was not bereaved | 42 | 35 |
| Overall Study | Caregiver withdrew | 3 | 3 |
| Overall Study | Patient died | 3 | 1 |
| Overall Study | Patient lost to followup | 0 | 1 |
| Overall Study | Patient withdrew | 6 | 5 |
Baseline characteristics
| Characteristic | Intervention: Communication Training | Control: Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 26 Participants | 55 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 27 Participants | 48 Participants |
| Age, Continuous | 64.2 years STANDARD_DEVIATION 11.7 | 64.5 years STANDARD_DEVIATION 11 | 64.4 years STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 6 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) Caregivers White | 44 Participants | 46 Participants | 90 Participants |
| Race (NIH/OMB) patients American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) patients Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) patients Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) patients More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) patients Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) patients Unknown or Not Reported | 14 Participants | 16 Participants | 30 Participants |
| Race (NIH/OMB) patients White | 116 Participants | 119 Participants | 235 Participants |
| Region of Enrollment United States | 50 participants | 135 participants | 265 participants |
| Sex: Female, Male Caregivers Female | 25 Participants | 29 Participants | 54 Participants |
| Sex: Female, Male Caregivers Male | 25 Participants | 24 Participants | 49 Participants |
| Sex: Female, Male patients Female | 76 Participants | 70 Participants | 146 Participants |
| Sex: Female, Male patients Male | 54 Participants | 65 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 91 / 139 | 96 / 142 | 1 / 105 | 0 / 99 |
| other Total, other adverse events | 0 / 139 | 0 / 142 | 0 / 105 | 0 / 99 |
| serious Total, serious adverse events | 0 / 139 | 0 / 142 | 0 / 105 | 0 / 99 |
Outcome results
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.
Time frame: 3 years
Population: This outcome measure was assessed in patients only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Mean Patient-centered Communication in Advanced Cancer Score | 0.16 standardized score on a scale | Standard Deviation 0.81 |
| Control | Mean Patient-centered Communication in Advanced Cancer Score | -0.01 standardized score on a scale | Standard Deviation 0.66 |
Comparison: 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.p-value: 0.0595% CI: [0.06, 0.62]Mixed Models Analysis
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.
Time frame: 3 years
Population: This outcome measure was assessed in patients only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians | 2.2 units on a scale | Standard Deviation 1.5 |
| Control | Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians | 2.5 units on a scale | Standard Deviation 1.6 |
p-value: 0.0595% CI: [-0.56, 0.37]Mixed Models Analysis
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.
Time frame: 3 years
Population: This outcome measure was assessed in patients only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Aim 2 Patient Well-being | -0.01 standardized score on a scale | Standard Deviation 0.73 |
| Control | Aim 2 Patient Well-being | -0.07 standardized score on a scale | Standard Deviation 0.8 |
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.
Time frame: 7 months
Population: Sf-12 was given to the caregivers only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment | 48.9 units on a scale | Standard Deviation 9.6 |
| Control | Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment | 47.9 units on a scale | Standard Deviation 11.5 |
p-value: 0.677Mixed Models Analysis
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.
Time frame: 7 months
Population: This instrument was used with caregivers only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13 | 19.3 units on a scale | Standard Deviation 5.9 |
| Control | Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13 | 20.6 units on a scale | Standard Deviation 6.8 |
p-value: 0.214Mixed Models Analysis
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.
Time frame: 3 years
Population: Health care utilization was assessed in patients only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life | 0.76 units on a scale | Standard Deviation 1.1 |
| Control | Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life | 0.58 units on a scale | Standard Deviation 0.9 |
p-value: 0.19Mixed Models Analysis