Trial Outcomes & Findings for Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2 (NCT NCT04179305)
NCT ID: NCT04179305
Last Updated: 2023-04-24
Results Overview
Changes in illness understanding by patients as measured by three items from the investigator's validated 4-item assessment will be compared between groups at baseline and post-scan follow-up. The assessment asks three questions that assess patients' recognition of their incurable disease status, knowledge of the advanced stage of their disease, and expectation to live months as opposed to years. Responses are coded 1 or 0 to indicate the presence or absence of each of these element. These four indicators are then added together to construct summary scores (possible range, 0 to 3). Differences between pre- and post-scan visit illness understanding scores (possible range, -3 to 3) are used to define changes in illness understanding by a patient between the pre- and post-scan visit interviews. Higher total scores represent an increase in prognostic understanding. Lower scores represent a decrease in understanding.
COMPLETED
NA
37 participants
Baseline; week after scan. 2- and - 4-month assessments were ultimately not done as participants preferred not to commit to follow-up.
2023-04-24
Participant Flow
Recruitment was carried out between 10/2020 and 6/2022 in outpatient GI and thoracic cancer clinics at Weill Cornell Medicine/New York Presbyterian. Patients were first chart-screened, and the treating oncologist's prognosis and permission were obtained for those potentially eligible. Patients were approached by phone (when COVID conditions required) or in clinic after an appointment with their oncologist.
Group assignment was not random, but was based on the arm of the participating patient's physician: GIST-trained or usual care. Screening for cognitive deficit and health literacy occurred prior to enrollment. Following enrollment, one patient withdrew due to time constraints and one was lost to follow-up.
Participant milestones
| Measure |
Oncolo-GIST Arm - Patients
Patients assigned to this arm will will discuss scan results revealing progressive disease with an Oncolo-GIST trained physician.
Oncolo-GIST: Behavioral: Oncolo-GIST Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in "gist communication" by itemizing 4 key steps in the process of imparting prognostic information.
Topic covered include:
Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis.
The 4-step guide will include brief video-clips of demonstrating each "talking point" with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith.
|
Usual Care Arm - Patients
Patients assigned to this arm will will discuss scan results revealing progressive disease with a physician that was not trained with the Oncolo-GIST intervention.
Usual Care Arm: Oncologists will provide care in non-specific manner.
|
Oncolo-GIST Arm - Physicians
Physicians assigned to this arm will receive the Oncolo-GIST training intervention.
|
Usual Care Arm - Physicians
Physicians assigned to this arm will not receive the Oncolo-GIST training intervention.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
14
|
2
|
2
|
|
Overall Study
Completed Patient Baseline Assessment
|
18
|
13
|
0
|
0
|
|
Overall Study
Had Progression on Scan
|
13
|
12
|
0
|
0
|
|
Overall Study
Completed Post-scan Assessment
|
13
|
11
|
0
|
0
|
|
Overall Study
Completed Physician Demographics Survey
|
0
|
0
|
2
|
2
|
|
Overall Study
Completed Physician Oncolo-GIST Quiz
|
0
|
0
|
2
|
0
|
|
Overall Study
Completed Physician Post-study Questionnaire
|
0
|
0
|
2
|
2
|
|
Overall Study
COMPLETED
|
13
|
11
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Oncolo-GIST Arm - Patients
Patients assigned to this arm will will discuss scan results revealing progressive disease with an Oncolo-GIST trained physician.
Oncolo-GIST: Behavioral: Oncolo-GIST Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in "gist communication" by itemizing 4 key steps in the process of imparting prognostic information.
Topic covered include:
Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis.
The 4-step guide will include brief video-clips of demonstrating each "talking point" with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith.
|
Usual Care Arm - Patients
Patients assigned to this arm will will discuss scan results revealing progressive disease with a physician that was not trained with the Oncolo-GIST intervention.
Usual Care Arm: Oncologists will provide care in non-specific manner.
|
Oncolo-GIST Arm - Physicians
Physicians assigned to this arm will receive the Oncolo-GIST training intervention.
|
Usual Care Arm - Physicians
Physicians assigned to this arm will not receive the Oncolo-GIST training intervention.
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Did not have scan
|
1
|
0
|
0
|
0
|
|
Overall Study
In hospice care
|
3
|
0
|
0
|
0
|
Baseline Characteristics
Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2
Baseline characteristics by cohort
| Measure |
Oncolo-GIST Arm - Patients
n=18 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with an Oncolo-GIST trained physician.
Oncolo-GIST: Behavioral: Oncolo-GIST Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in "gist communication" by itemizing 4 key steps in the process of imparting prognostic information.
Topic covered include:
Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis.
The 4-step guide will include brief video-clips of demonstrating each "talking point" with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith.
|
Usual Care Arm - Patients
n=13 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with a physician that was not trained with the Oncolo-GIST intervention.
Usual Care Arm: Oncologists will provide care in non-specific manner.
|
Oncolo-GIST Arm - Physicians
n=2 Participants
Physicians assigned to this arm will receive the Oncolo-GIST training intervention.
|
Usual Care Arm - Physicians
n=2 Participants
Physicians assigned to this arm will not receive the Oncolo-GIST training intervention.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
66.3 years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Cancer type (Diagnosis for patients; treatment specialty for physicians)
Gastrointestinal
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Cancer type (Diagnosis for patients; treatment specialty for physicians)
Thoracic
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Religion
Christian
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Religion
Jewish
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Religion
Muslim
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Religion
Other Religion
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Religion
No Religion
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Education
Did Not Complete High School
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Education
High School
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Education
Some College
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Education
College Degree
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Education
Graduate Degree
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline; week after scan. 2- and - 4-month assessments were ultimately not done as participants preferred not to commit to follow-up.Population: 1 patient on the Oncolo-GIST arm was not analyzed due to not having completed the post-scan visit interview. Not relevant to Physician arm participants. The investigators did not include one item from the validated 4-item scale (terminal illness acknowledgement) in the follow-up assessment due to technical error, and so the measure was limited to the three items for which there was follow-up data. 2- and - 4-month assessments were not done as participants preferred not to commit to follow-up.
Changes in illness understanding by patients as measured by three items from the investigator's validated 4-item assessment will be compared between groups at baseline and post-scan follow-up. The assessment asks three questions that assess patients' recognition of their incurable disease status, knowledge of the advanced stage of their disease, and expectation to live months as opposed to years. Responses are coded 1 or 0 to indicate the presence or absence of each of these element. These four indicators are then added together to construct summary scores (possible range, 0 to 3). Differences between pre- and post-scan visit illness understanding scores (possible range, -3 to 3) are used to define changes in illness understanding by a patient between the pre- and post-scan visit interviews. Higher total scores represent an increase in prognostic understanding. Lower scores represent a decrease in understanding.
Outcome measures
| Measure |
Oncolo-GIST Arm - Patients
n=12 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with an Oncolo-GIST trained physician.
Oncolo-GIST: Behavioral: Oncolo-GIST Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in "gist communication" by itemizing 4 key steps in the process of imparting prognostic information.
Topics covered include:
Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis.
The 4-step guide will include brief video-clips of demonstrating each "talking point" with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith.
|
Usual Care Arm - Patients
n=11 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with a physician that was not trained with the Oncolo-GIST intervention.
Usual Care Arm: Oncologists will provide care in non-specific manner.
|
Oncolo-GIST Arm - Physicians
Physicians assigned to this arm will receive the Oncolo-GIST training intervention.
|
Usual Care Arm - Physicians
Physicians assigned to this arm will not receive the Oncolo-GIST training intervention.
|
|---|---|---|---|---|
|
Change in Prognostic Understanding
|
0.58 units on a scale
Standard Deviation 1.00
|
0.18 units on a scale
Standard Deviation 1.25
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, within one week, 2 months, 4 monthPopulation: Data was not collected for this measure.
Quality of life of patients, as measured by the McGill Quality of Life Questionnaire, will be compared between groups at one-week, two-month and 4-month follow up assessments (T2, T3, and T4). This questionnaire contains 16 items and each item uses a 10-point scale, where 0 is desirable and 10 is undesirable. Separate sub-scales scoring for global, physical, psychological, emotional and existential well-being, are determined by taking the mean of the associated items. The score for overall quality of life is determined by taking the mean of all the sub-scales. Higher total scores represent better quality of life. Lower scores represent worse better quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week post-scan, 2 months post-scan, 4 months post-scan.Population: All patients who completed follow-up assessments and therefore had a medical chart review. This measure is not relevant to physician participants. 4-month assessments were ultimately not done, as participants preferred not to commit to follow-up.
Whether or not a Do Not Resuscitate (DNR) was ordered by the patient, as determined by a medical chart abstraction, will be compared between groups at 2-month and 4-month follow up assessments (T4). This will be scored as either a 0, if there was no DNR ordered, or a 1 if there was a DNR ordered.
Outcome measures
| Measure |
Oncolo-GIST Arm - Patients
n=13 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with an Oncolo-GIST trained physician.
Oncolo-GIST: Behavioral: Oncolo-GIST Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in "gist communication" by itemizing 4 key steps in the process of imparting prognostic information.
Topics covered include:
Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis.
The 4-step guide will include brief video-clips of demonstrating each "talking point" with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith.
|
Usual Care Arm - Patients
n=11 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with a physician that was not trained with the Oncolo-GIST intervention.
Usual Care Arm: Oncologists will provide care in non-specific manner.
|
Oncolo-GIST Arm - Physicians
Physicians assigned to this arm will receive the Oncolo-GIST training intervention.
|
Usual Care Arm - Physicians
Physicians assigned to this arm will not receive the Oncolo-GIST training intervention.
|
|---|---|---|---|---|
|
Whether or Not a Do Not Resuscitate Was Ordered by Patient
1 Week Post-Scan
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Whether or Not a Do Not Resuscitate Was Ordered by Patient
2 months Post-Scan
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 week post-scan, 2 months post-scan, 4 months post-scan.Population: Data collection for this outcome was discontinued when the assessment at 4 months was eliminated. No data was collected at 4 months.
Methods of treatment and care received by patients, as determined from a medical chart abstraction, will be compared between groups at 2-month and 4-month follow up assessments (T4). Types of care include palliative care, hospice and hospitalization. Types of treatment include chemotherapy drugs, narcotic pain medication and radiation therapy.
Outcome measures
| Measure |
Oncolo-GIST Arm - Patients
n=10 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with an Oncolo-GIST trained physician.
Oncolo-GIST: Behavioral: Oncolo-GIST Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in "gist communication" by itemizing 4 key steps in the process of imparting prognostic information.
Topics covered include:
Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis.
The 4-step guide will include brief video-clips of demonstrating each "talking point" with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith.
|
Usual Care Arm - Patients
n=7 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with a physician that was not trained with the Oncolo-GIST intervention.
Usual Care Arm: Oncologists will provide care in non-specific manner.
|
Oncolo-GIST Arm - Physicians
Physicians assigned to this arm will receive the Oncolo-GIST training intervention.
|
Usual Care Arm - Physicians
Physicians assigned to this arm will not receive the Oncolo-GIST training intervention.
|
|---|---|---|---|---|
|
Treatment and Care Received
1 Week Post-Scan : Patients enrolled in hospice care
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Treatment and Care Received
1 Week Post-Scan : Patients who had had a palliative care consult
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Treatment and Care Received
1 Week Post-Scan: Patients who had been hospitalized within the past week.
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Treatment and Care Received
1 Week Post-Scan: Patients who were receiving chemotherapy
|
10 Participants
|
6 Participants
|
—
|
—
|
|
Treatment and Care Received
1 Week Post-Scan: Patients who were receiving radiation therapy
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Treatment and Care Received
1 Week Post-Scan: Patients who were receiving narcotic pain medication
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Treatment and Care Received
2 Months Post-Scan : Patients enrolled in hospice care
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Treatment and Care Received
2 Months Post-Scan : Patients who had had a palliative care consult
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Treatment and Care Received
2 Months Post-Scan: Patients who had been hospitalized within the past week.
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Treatment and Care Received
2 Months Post-Scan: Patients who were receiving chemotherapy
|
10 Participants
|
7 Participants
|
—
|
—
|
|
Treatment and Care Received
2 Months Post-Scan: Patients who were receiving radiation therapy
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Treatment and Care Received
2 Months Post-Scan: Patients who were receiving narcotic pain medication
|
7 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 week post-scan, 2 months post-scan.Population: Data was not collected for this measure. Patient performance status was not noted in the majority of patients' charts, and where it was noted, physicians used differing scales.
Methods of treatment and care received by patients, as determined from a medical chart abstraction, will be compared between groups at 2-month and 4-month follow up assessments (T4). Types of care include palliative care, hospice and hospitalization. Types of treatment include chemotherapy drugs, narcotic pain medication and radiation therapy.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Baseline, week after scan.Population: All participants who completed follow-up assessments. This measure is not relevant to physician participants.
Changes in 11-item Human Connection Scale (Mack et al., 2009) total score and individual item scores after scan discussion. Total scores have a range of 0-44 and are calculated by summing individual item scores from the 11 items on the assessment. Individual items are scored from 0-4. In both cases, higher scores mean a better outcome: a stronger physician-patient therapeutic alliance. Change scores are calculated by subtracting the mean at the week after scan (T1) from the mean at baseline. A positive change indicates a better outcome (strengthening of the therapeutic alliance), whereas a negative change indicates a worse outcome (weakening of the therapeutic alliance).
Outcome measures
| Measure |
Oncolo-GIST Arm - Patients
n=13 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with an Oncolo-GIST trained physician.
Oncolo-GIST: Behavioral: Oncolo-GIST Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in "gist communication" by itemizing 4 key steps in the process of imparting prognostic information.
Topics covered include:
Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis.
The 4-step guide will include brief video-clips of demonstrating each "talking point" with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith.
|
Usual Care Arm - Patients
n=11 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with a physician that was not trained with the Oncolo-GIST intervention.
Usual Care Arm: Oncologists will provide care in non-specific manner.
|
Oncolo-GIST Arm - Physicians
Physicians assigned to this arm will receive the Oncolo-GIST training intervention.
|
Usual Care Arm - Physicians
Physicians assigned to this arm will not receive the Oncolo-GIST training intervention.
|
|---|---|---|---|---|
|
Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in Human Connection Scale total score
|
-1.00 score on a scale
Standard Deviation 1.63
|
0.14 score on a scale
Standard Deviation 1.57
|
—
|
—
|
|
Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in individual item: Likes oncologist
|
0.00 score on a scale
Standard Deviation 0.00
|
0.00 score on a scale
Standard Deviation 0.00
|
—
|
—
|
|
Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in individual item: trusts oncologist
|
0.00 score on a scale
Standard Deviation 0.00
|
0.00 score on a scale
Standard Deviation 0.00
|
—
|
—
|
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Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in individual item: Oncologist is concerned about your quality of life.
|
0.23 score on a scale
Standard Deviation 0.44
|
0.27 score on a scale
Standard Deviation 1.01
|
—
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—
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Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in individual item: doctor asks how you are coping with cancer.
|
0.15 score on a scale
Standard Deviation 0.80
|
0.09 score on a scale
Standard Deviation 1.14
|
—
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—
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Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in individual item: Doctor asks how family members are coping with illness.
|
0.50 score on a scale
Standard Deviation 1.27
|
0.20 score on a scale
Standard Deviation 0.63
|
—
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—
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Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in individual item: Feels comfortable asking doctor questions.
|
-0.42 score on a scale
Standard Deviation 0.90
|
0.00 score on a scale
Standard Deviation 0.00
|
—
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—
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Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in individual item: Oncologist takes the time to listen to concerns.
|
-0.08 score on a scale
Standard Deviation 0.64
|
0.00 score on a scale
Standard Deviation 0.45
|
—
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—
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Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in individual item: Oncologist sees you as a whole person.
|
-0.08 score on a scale
Standard Deviation 0.28
|
0.00 score on a scale
Standard Deviation 0.00
|
—
|
—
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Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in individual item: Oncologist cares about you.
|
-0.08 score on a scale
Standard Deviation 0.49
|
0.00 score on a scale
Standard Deviation 0.00
|
—
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—
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Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in individual item: Oncologist is honest with you.
|
0.00 score on a scale
Standard Deviation 0.47
|
0.00 score on a scale
Standard Deviation 0.00
|
—
|
—
|
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Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale
Change in individual item: Oncologist offers hope.
|
-0.22 score on a scale
Standard Deviation 0.67
|
0.11 score on a scale
Standard Deviation 0.33
|
—
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—
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POST_HOC outcome
Timeframe: Baseline, week after scanPopulation: All patients who completed follow-up assessments. This measure is not relevant to physician participants.
Changes in Hospital Anxiety and Depression Scale Anxiety and Depression subscores, each with a minimum of 0 and maximum of 21, with a higher score meaning a worse outcome and a negative change between timepoints indicating improvement.
Outcome measures
| Measure |
Oncolo-GIST Arm - Patients
n=13 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with an Oncolo-GIST trained physician.
Oncolo-GIST: Behavioral: Oncolo-GIST Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in "gist communication" by itemizing 4 key steps in the process of imparting prognostic information.
Topics covered include:
Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis.
The 4-step guide will include brief video-clips of demonstrating each "talking point" with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith.
|
Usual Care Arm - Patients
n=11 Participants
Patients assigned to this arm will will discuss scan results revealing progressive disease with a physician that was not trained with the Oncolo-GIST intervention.
Usual Care Arm: Oncologists will provide care in non-specific manner.
|
Oncolo-GIST Arm - Physicians
Physicians assigned to this arm will receive the Oncolo-GIST training intervention.
|
Usual Care Arm - Physicians
Physicians assigned to this arm will not receive the Oncolo-GIST training intervention.
|
|---|---|---|---|---|
|
Change in Anxiety and Depression as Measured by the Hospital Anxiety and Depression Scale Anxiety and Depression Subscores
Anxiety subscore change
|
0.64 score on a scale
Standard Deviation 2.50
|
0.40 score on a scale
Standard Deviation 1.43
|
—
|
—
|
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Change in Anxiety and Depression as Measured by the Hospital Anxiety and Depression Scale Anxiety and Depression Subscores
Depression subscore change
|
1.64 score on a scale
Standard Deviation 3.80
|
2.45 score on a scale
Standard Deviation 3.14
|
—
|
—
|
Adverse Events
Oncolo-GIST Arm - Patients
Usual Care Arm - Patients
Oncolo-GIST Arm - Physicians
Usual Care Arm - Physicians
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place