Trial Outcomes & Findings for Pre-consultation Compassion Among Patients Referred to a Cancer Center (NCT NCT04503681)
NCT ID: NCT04503681
Last Updated: 2024-11-21
Results Overview
Seven item subscale. Each item is scored on a 4-point scale (0=not at all to 3=nearly all the time); thus, range from 0-21. Higher score indicates greater anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
374 participants
Primary outcome timeframe
Baseline (on arrival to the cancer center for an initial oncology consultant).
Results posted on
2024-11-21
Participant Flow
Participant milestones
| Measure |
Standard Introduction Video
Standard introduction video: Standard introduction video sent to a new patient via email introducing the new patient to the cancer center prior to the initial consultation.
|
Enhanced Compassion Video
Enhanced compassion video: Added five additional sentences to the standard introduction video. Those five sentences were compassion-focused statements. The compassionate statements added to the "enhanced compassion video" were based on the results of a recent systematic review of clinician compassionate behaviors, which found incorporating statements of support, acknowledgement, patient's perspective, emotion naming, and validation increased patient perception of compassion.
|
|---|---|---|
|
Overall Study
STARTED
|
188
|
186
|
|
Overall Study
COMPLETED
|
183
|
179
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Standard Introduction Video
Standard introduction video: Standard introduction video sent to a new patient via email introducing the new patient to the cancer center prior to the initial consultation.
|
Enhanced Compassion Video
Enhanced compassion video: Added five additional sentences to the standard introduction video. Those five sentences were compassion-focused statements. The compassionate statements added to the "enhanced compassion video" were based on the results of a recent systematic review of clinician compassionate behaviors, which found incorporating statements of support, acknowledgement, patient's perspective, emotion naming, and validation increased patient perception of compassion.
|
|---|---|---|
|
Overall Study
Subjects did not complete outcome questionnaire
|
5
|
7
|
Baseline Characteristics
Pre-consultation Compassion Among Patients Referred to a Cancer Center
Baseline characteristics by cohort
| Measure |
Standard Introduction Video
n=188 Participants
Standard introduction video: Standard introduction video sent to a new patient via email introducing the new patient to the cancer center prior to the initial consultation.
|
Enhanced Compassion Video
n=186 Participants
Enhanced compassion video: Added five additional sentences to the standard introduction video. Those five sentences were compassion-focused statements. The compassionate statements added to the "enhanced compassion video" were based on the results of a recent systematic review of clinician compassionate behaviors, which found incorporating statements of support, acknowledgement, patient's perspective, emotion naming, and validation increased patient perception of compassion.
|
Total
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 13 • n=99 Participants
|
62 years
STANDARD_DEVIATION 11 • n=107 Participants
|
62 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
238 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
179 Participants
n=99 Participants
|
179 Participants
n=107 Participants
|
358 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
129 Participants
n=99 Participants
|
133 Participants
n=107 Participants
|
262 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (on arrival to the cancer center for an initial oncology consultant).Seven item subscale. Each item is scored on a 4-point scale (0=not at all to 3=nearly all the time); thus, range from 0-21. Higher score indicates greater anxiety.
Outcome measures
| Measure |
Standard Introduction Video
n=183 Participants
Standard introduction video: Standard introduction video sent to a new patient via email introducing the new patient to the cancer center prior to the initial consultation.
|
Enhanced Compassion Video
n=179 Participants
Enhanced compassion video: Added five additional sentences to the standard introduction video. Those five sentences were compassion-focused statements. The compassionate statements added to the "enhanced compassion video" were based on the results of a recent systematic review of clinician compassionate behaviors, which found incorporating statements of support, acknowledgement, patient's perspective, emotion naming, and validation increased patient perception of compassion.
|
|---|---|---|
|
Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS)
|
7 score on a scale
Interval 4.0 to 10.0
|
7 score on a scale
Interval 4.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline (on arrival to the cancer center for an initial oncology consultant).Seven item subscale. Each item is scored on a 4-point scale (0=not at all to 3=nearly all the time); thus, range from 0-21. Higher score indicates greater depression
Outcome measures
| Measure |
Standard Introduction Video
n=183 Participants
Standard introduction video: Standard introduction video sent to a new patient via email introducing the new patient to the cancer center prior to the initial consultation.
|
Enhanced Compassion Video
n=179 Participants
Enhanced compassion video: Added five additional sentences to the standard introduction video. Those five sentences were compassion-focused statements. The compassionate statements added to the "enhanced compassion video" were based on the results of a recent systematic review of clinician compassionate behaviors, which found incorporating statements of support, acknowledgement, patient's perspective, emotion naming, and validation increased patient perception of compassion.
|
|---|---|---|
|
Depression Subscale of the Hospital Anxiety and Depression Scale
|
3 score on a scale
Interval 1.0 to 6.0
|
3 score on a scale
Interval 1.0 to 6.0
|
Adverse Events
Standard Introduction Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Compassion Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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