Trial Outcomes & Findings for Electronic Patient Reporting of Symptoms During Cancer Treatment (NCT NCT03249090)
NCT ID: NCT03249090
Last Updated: 2025-01-14
Results Overview
Unadjusted Kaplan-Meier estimated survival, based on administrative datasets and practice self-report/medical records.
COMPLETED
NA
1197 participants
24 months
2025-01-14
Participant Flow
Participants were recruited at 52 community oncology practices across 25 states between October 2017 and March 2020. The first participant was enrolled on October 30, 2017 and the last participant was enrolled on March 16, 2020. Enrollment was halted short of the enrollment goal of 1200 participants due the uncertainties of the COVID 19 pandemic.
1444 participants were assessed for eligibility and 247 were excluded for the following reasons: 93 did not meet the inclusion criteria 154 declined to participate (1 not enough time to consent, 36 study would take up too much time, 11 patient too sick, 2 patient functional limitations, 41 did not want to fill out survey, 8 did not want contact between visits, 55 no reason given)
Unit of analysis: Practices
Participant milestones
| Measure |
ePRO Intervention
Patients report symptoms weekly via web or automated telephone system (electronic patient reported outcomes (ePROs)). Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.
|
Usual Care Control
Evidence-based symptom management pathways provided to patients and clinicians
Usual Care Control: Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
|
|---|---|---|
|
Enrollment
STARTED
|
597 26
|
600 26
|
|
Enrollment
COMPLETED
|
593 26
|
598 26
|
|
Enrollment
NOT COMPLETED
|
4 0
|
2 0
|
|
3 Month Time Point
STARTED
|
593 26
|
598 26
|
|
3 Month Time Point
COMPLETED
|
542 26
|
556 26
|
|
3 Month Time Point
NOT COMPLETED
|
51 0
|
42 0
|
|
12 Month Time Point
STARTED
|
542 26
|
556 26
|
|
12 Month Time Point
COMPLETED
|
315 26
|
368 26
|
|
12 Month Time Point
NOT COMPLETED
|
227 0
|
188 0
|
Reasons for withdrawal
| Measure |
ePRO Intervention
Patients report symptoms weekly via web or automated telephone system (electronic patient reported outcomes (ePROs)). Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.
|
Usual Care Control
Evidence-based symptom management pathways provided to patients and clinicians
Usual Care Control: Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
|
|---|---|---|
|
Enrollment
Excluded after randomization for ineligibility
|
4
|
2
|
|
3 Month Time Point
Death, hospice, discontinued therapy
|
41
|
37
|
|
3 Month Time Point
Voluntary withdrawal
|
6
|
3
|
|
3 Month Time Point
Changed oncology practice
|
4
|
2
|
|
12 Month Time Point
Death, hospice, discontinued therapy
|
172
|
175
|
|
12 Month Time Point
Voluntary withdrawal
|
35
|
4
|
|
12 Month Time Point
Changed oncology practice
|
20
|
9
|
Baseline Characteristics
Electronic Patient Reporting of Symptoms During Cancer Treatment
Baseline characteristics by cohort
| Measure |
ePRO Intervention
n=593 Participants
Patients report symptoms weekly via web or automated telephone system (electronic patient reported outcomes (ePROs)). Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.
|
Usual Care Control
n=598 Participants
Evidence-based symptom management pathways provided to patients and clinicians
Usual Care Control: Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
|
Total
n=1191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
64 years
n=5 Participants
|
62 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
359 Participants
n=5 Participants
|
335 Participants
n=7 Participants
|
694 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
234 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
496 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
577 Participants
n=5 Participants
|
557 Participants
n=7 Participants
|
1134 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
99 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
473 Participants
n=5 Participants
|
452 Participants
n=7 Participants
|
925 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Education
1st-8th Grade
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Education
9th-11th Grade
|
35 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Education
High School Graduate/GED
|
173 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Education
Some College, Associate's Degree, Other Certification
|
218 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
|
Education
College Degree
|
91 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Education
Advanced Degree
|
65 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Education
Missing
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Urban or Rural Site
Participants at Rural Site
|
154 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
317 Participants
n=5 Participants
|
|
Urban or Rural Site
Participants at Urban Site
|
439 Participants
n=5 Participants
|
435 Participants
n=7 Participants
|
874 Participants
n=5 Participants
|
|
Difficulty Paying Bills
Not at all
|
260 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
484 Participants
n=5 Participants
|
|
Difficulty Paying Bills
Not very
|
106 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Difficulty Paying Bills
Somewhat
|
161 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
345 Participants
n=5 Participants
|
|
Difficulty Paying Bills
Very/extremely
|
65 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Difficulty Paying Bills
Missing
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Cancer Type
Colorectal, anal
|
100 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Cancer Type
Thoracic (Lung, Thyroid, Thymus)
|
118 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Cancer Type
Breast
|
97 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Cancer Type
Gyn (Ovarian, Cervix, Uterine, Vaginal)
|
64 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Cancer Type
Pancreas, Hepatobiliary
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Cancer Type
Gastroesophageal, Small bowel
|
25 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Cancer Type
Genitourinary Non-prostate (Bladder, Kidney, Testicular, Penile)
|
36 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Cancer Type
Myeloma, Lymphoma
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Cancer Type
Prostate
|
33 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Cancer Type
Melanoma, Skin
|
11 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Cancer Type
Other (Brain, Sarcoma, Other Soft Tissue, Head/Neck, Unknown Primary)
|
30 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Line of Cancer Therapy
1st Line
|
207 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
444 Participants
n=5 Participants
|
|
Line of Cancer Therapy
2nd Line
|
176 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
|
Line of Cancer Therapy
3rd Line
|
102 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Line of Cancer Therapy
4th Line
|
108 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Enrolled eligible patients
Unadjusted Kaplan-Meier estimated survival, based on administrative datasets and practice self-report/medical records.
Outcome measures
| Measure |
ePRO Intervention
n=593 Participants
Patients report symptoms weekly via web or automated telephone system (electronic patient reported outcomes (ePROs)). Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.
|
Usual Care Control
n=598 Participants
Evidence-based symptom management pathways provided to patients and clinicians
Usual Care Control: Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
|
|---|---|---|
|
Overall Survival
|
42.0 percentage of participants
Interval 38.2 to 46.2
|
43.5 percentage of participants
Interval 39.7 to 47.6
|
SECONDARY outcome
Timeframe: Month 3Population: Patients who completed the QLQ C30 measure at the 3 month time point.
Physical functioning was measured at the 3 month time point using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. The QLQ-C30 is a widely used 30 item questionnaire with excellent measurement properties. Physical functioning was assessed via 5 items from the QLQ-C30 which generated a single score on a 0-100 point scale (higher scores are better). Mean changes from baseline were measured using the QLQ-C30 at 3 months and compared between arms with a linear combination of parameters from a general linear mixed model. Patients who completed the QLQ C30 at baseline and each follow up time point were categorized as improved on each outcome if their score increased by \>/=5 points from baseline; worse if their score decreased by \>/=5 points and otherwise as stable.
Outcome measures
| Measure |
ePRO Intervention
n=522 Participants
Patients report symptoms weekly via web or automated telephone system (electronic patient reported outcomes (ePROs)). Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.
|
Usual Care Control
n=544 Participants
Evidence-based symptom management pathways provided to patients and clinicians
Usual Care Control: Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
|
|---|---|---|
|
Physical Functioning
Non-responder for Physical Functioning (score changed <5 points from baseline)
|
133 Participants
|
147 Participants
|
|
Physical Functioning
Improved Physical Functioning (score increased >/=5 points from baseline)
|
227 Participants
|
195 Participants
|
|
Physical Functioning
Worsened Physical Functioning (score decreased >/=5 points from baseline)
|
162 Participants
|
202 Participants
|
SECONDARY outcome
Timeframe: Month 3Population: Patients who completed the QLQ-C30 measure at the 3-month time point.
Symptom control was measured at the 3 month time point using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. The QLQ-C30 is a widely used 30 item questionnaire with excellent measurement properties. Symptom control was assessed as a composite of 8 QLQ-C30 symptom scale scores on a 0-100 point scale (higher scores are better). Mean changes from baseline were measured using the QLQ-C30 at 3 months and compared between arms with a linear combination of parameters from a general linear mixed model. Patients who completed the QLQ C30 at baseline and each follow up time point were categorized as improved on each outcome if their score increased by \>/=5 points from baseline; worse if their score decreased by \>/=5 points and otherwise as stable.
Outcome measures
| Measure |
ePRO Intervention
n=517 Participants
Patients report symptoms weekly via web or automated telephone system (electronic patient reported outcomes (ePROs)). Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.
|
Usual Care Control
n=543 Participants
Evidence-based symptom management pathways provided to patients and clinicians
Usual Care Control: Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
|
|---|---|---|
|
Symptom Control
Improved Symptom Control (score increased >/=5 points from baseline)
|
195 Participants
|
158 Participants
|
|
Symptom Control
Non-responder for Symptom Control (score changed <5 points from baseline)
|
199 Participants
|
215 Participants
|
|
Symptom Control
Worsened Symptom Control (score decreased >/=5 points from baseline)
|
123 Participants
|
170 Participants
|
SECONDARY outcome
Timeframe: Month 3Population: Patients who completed the QLQ-C30 measure at the 3-month time point.
Health-related quality of life was measured at the 3 month time point using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. The QLQ-C30 is a widely used 30 item questionnaire with excellent measurement properties. Health-related quality of life was assessed as a composite of function and symptom scale scores on a 0-100 point scale (higher scores are better). Mean changes from baseline were measured using the QLQ-C30 at 3 months and compared between arms with a linear combination of parameters from a general linear mixed model. Patients who completed the QLQ C30 at baseline and each follow up time point were categorized as improved on each outcome if their score increased by \>/=5 points from baseline; worse if their score decreased by \>/=5 points and otherwise as stable.
Outcome measures
| Measure |
ePRO Intervention
n=517 Participants
Patients report symptoms weekly via web or automated telephone system (electronic patient reported outcomes (ePROs)). Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.
|
Usual Care Control
n=543 Participants
Evidence-based symptom management pathways provided to patients and clinicians
Usual Care Control: Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
|
|---|---|---|
|
Health-related Quality of Life
Improved Health-related Quality of Life (score increased >/=5 points from baseline)
|
191 Participants
|
154 Participants
|
|
Health-related Quality of Life
Non-responder for Health-related Quality of Life (score changed <5 points from baseline)
|
199 Participants
|
229 Participants
|
|
Health-related Quality of Life
Worsened Health-related Quality of Life (score decreased >/=5 points from baseline)
|
127 Participants
|
160 Participants
|
SECONDARY outcome
Timeframe: Month 3Population: Patients participating in the ePROs arm completed the Patient Feedback Survey to assess patient satisfaction with the system and communication with their care team.
Patients in the ePRO arm were measured via Patient Satisfaction Questionnaire assessing comprehension of ePRO questions, usability of digital ePRO system, meaningfulness/relevance of ePRO questions, communication/actionability with care team, clinical utility of ePRO system and patient self efficacy. The number of patients analyzed is the number of patients who completed the questions. Some questions were not administered to all patients.
Outcome measures
| Measure |
ePRO Intervention
n=505 Participants
Patients report symptoms weekly via web or automated telephone system (electronic patient reported outcomes (ePROs)). Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.
|
Usual Care Control
Evidence-based symptom management pathways provided to patients and clinicians
Usual Care Control: Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
|
|---|---|---|
|
Patient Satisfaction/Communication
Patients who strongly or somewhat agree that ePRO survey questions were easy to understand
|
480 participants
|
—
|
|
Patient Satisfaction/Communication
Patients who strongly or somewhat agree that the ePRO system was easy to use
|
472 participants
|
—
|
|
Patient Satisfaction/Communication
Patients who strongly or somewhat agree the ePRO survey questions were relevant to them
|
359 participants
|
—
|
|
Patient Satisfaction/Communication
Patients who strongly or somewhat agree the process improved discussions with their care team
|
365 participants
|
—
|
|
Patient Satisfaction/Communication
Patients who strongly or somewhat agree that their doctor/nurse used the symptom information
|
353 participants
|
—
|
|
Patient Satisfaction/Communication
Self-reporting symptoms weekly from home made them feel more in control of their care
|
387 participants
|
—
|
|
Patient Satisfaction/Communication
Patients who strongly or somewhat agree they would recommend the ePRO system to other patients
|
452 participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Enrolled eligible patients
Data for emergency department visits were obtained from data abstracted at each practice from the electronic medical record.
Outcome measures
| Measure |
ePRO Intervention
n=593 Participants
Patients report symptoms weekly via web or automated telephone system (electronic patient reported outcomes (ePROs)). Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.
|
Usual Care Control
n=598 Participants
Evidence-based symptom management pathways provided to patients and clinicians
Usual Care Control: Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
|
|---|---|---|
|
Emergency Department Utilization
No (0) ED Visits
|
315 Participants
|
273 Participants
|
|
Emergency Department Utilization
1+ ED Visits
|
278 Participants
|
325 Participants
|
Adverse Events
ePRO Intervention
Usual Care Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Investigator
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place