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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of North Carolina | OTHER |
| Mayo Clinic | OTHER |
| American Society of Clinical Oncology |
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The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.
This is a cluster RCT at approximately 50 sites where randomization will occur in a 1:1 ratio at the site level (not at the individual patient level). Therefore, approximately 25 sites will be randomized to the PRO-TECT intervention arm (patient-reporting of symptoms), and approximately 25 sites will be randomized to the control arm (usual care delivery). Approximately 1200 patients will be enrolled. Specifically:
PROCEDURES AT ALL SITES (CONTROL SITES AND INTERVENTION SITES):
ADDITIONAL PROCEDURES AT INTERVENTION SITES ONLY:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Self-Reporting of Symptoms | Experimental | Patients report symptoms weekly via web or automated telephone system. 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 Delivery | Active Comparator | Evidence-based symptom management pathways provided to patients and clinicians |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Self-Reporting of Symptoms | Other | At baseline, CRAs will train patients to self-report symptoms and physical functioning weekly for up to a year, with a choice to do so online or via an automated telephone system. Whenever a concerning symptom is reported, an automated "email alert" notification will be sent to the site CRA. The CRA will forward the alert to the responsible clinical nurse (or other covering clinician) and CC the site's Nurse Champion. Within 72 hours, the CRA will document what action(s), if any, were taken by the nurse in response to the alert (entered by the CRA into a form in the PRO-Core system). A symptom report will be printed/generated by the site CRA whenever the patient has a clinic visit and will be given to the oncologist and nurse caring for the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Unadjusted Kaplan-Meier estimated survival, based on administrative datasets and practice self-report/medical records. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Functioning | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ethan Basch, MD | University of North Carolina, Chapel Hill | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grand Valley Oncology | Grand Junction | Colorado | 81505 | United States | ||
| Gwinnett Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23822654 | Background | Basch E. Toward patient-centered drug development in oncology. N Engl J Med. 2013 Aug 1;369(5):397-400. doi: 10.1056/NEJMp1114649. Epub 2013 Jul 3. No abstract available. | |
| 23314601 | Background | Reilly CM, Bruner DW, Mitchell SA, Minasian LM, Basch E, Dueck AC, Cella D, Reeve BB. A literature synthesis of symptom prevalence and severity in persons receiving active cancer treatment. Support Care Cancer. 2013 Jun;21(6):1525-50. doi: 10.1007/s00520-012-1688-0. Epub 2013 Jan 12. |
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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)
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrollment |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2020 | Jan 18, 2024 |
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| OTHER |
| American Cancer Society, Inc. | OTHER |
| Dana-Farber Cancer Institute | OTHER |
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|
| Usual Care Delivery | Other | Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms |
|
| Month 3 |
| Symptom Control | 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. | Month 3 |
| Health-related Quality of Life | 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. | Month 3 |
| Patient Satisfaction/Communication | 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. | Month 3 |
| Emergency Department Utilization | Data for emergency department visits were obtained from data abstracted at each practice from the electronic medical record. | 1 year |
| Lawrenceville |
| Georgia |
| 30046 |
| United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Franciscan Health Indianapolis | Indianapolis | Indiana | 46237 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Union Hospital | Terre Haute | Indiana | 47804 | United States |
| University of Iowa Healthcare Cancer Services Quad Cities | Bettendorf | Iowa | 52722 | United States |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | 50309 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Meritus Medical Center | Hagerstown | Maryland | 21742 | United States |
| Lowell General Hospital | Lowell | Massachusetts | 01854 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| St. Joseph Mercy Ann Arbor Hospital | Ypsilanti | Michigan | 48197 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | 55426 | United States |
| Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center | Springfield | Missouri | 65804 | United States |
| Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | United States |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | 59715 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Nevada Cancer Specialists | Las Vegas | Nevada | 89102 | United States |
| New Hampshire Oncology Hematology PA-Hooksett | Hooksett | New Hampshire | 03106 | United States |
| Hematology Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
| Montefiore Medical Center/ Albert Einstein College of Medicine | The Bronx | New York | 10467 | United States |
| Cape Fear Valley Health System | Fayetteville | North Carolina | 28304 | United States |
| East Carolina University | Greenville | North Carolina | 27858 | United States |
| Rex Cancer Center | Raleigh | North Carolina | 27607 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Columbus NCI Community Oncology Research Program | Columbus | Ohio | 43215 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| WellSpan Health - York Cancer Center | York | Pennsylvania | 17403 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Centra Lynchburg Hematology Oncology Clinic | Lynchburg | Virginia | 24501 | United States |
| Edwards Comprehensive Cancer Center | Huntington | West Virginia | 25701 | United States |
| Saint Vincent Hospital Cancer Center | Green Bay | Wisconsin | 54301 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| 18204940 | Background | Henry DH, Viswanathan HN, Elkin EP, Traina S, Wade S, Cella D. Symptoms and treatment burden associated with cancer treatment: results from a cross-sectional national survey in the U.S. Support Care Cancer. 2008 Jul;16(7):791-801. doi: 10.1007/s00520-007-0380-2. Epub 2008 Jan 17. |
| 24114037 | Background | Cleeland CS, Zhao F, Chang VT, Sloan JA, O'Mara AM, Gilman PB, Weiss M, Mendoza TR, Lee JW, Fisch MJ. The symptom burden of cancer: Evidence for a core set of cancer-related and treatment-related symptoms from the Eastern Cooperative Oncology Group Symptom Outcomes and Practice Patterns study. Cancer. 2013 Dec 15;119(24):4333-40. doi: 10.1002/cncr.28376. Epub 2013 Sep 24. |
| 15337796 | Background | Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol. 2004 Sep 1;22(17):3485-90. doi: 10.1200/JCO.2004.03.025. |
| 20858248 | Background | Laugsand EA, Sprangers MA, Bjordal K, Skorpen F, Kaasa S, Klepstad P. Health care providers underestimate symptom intensities of cancer patients: a multicenter European study. Health Qual Life Outcomes. 2010 Sep 21;8:104. doi: 10.1186/1477-7525-8-104. |
| 21984468 | Background | Atkinson TM, Li Y, Coffey CW, Sit L, Shaw M, Lavene D, Bennett AV, Fruscione M, Rogak L, Hay J, Gonen M, Schrag D, Basch E. Reliability of adverse symptom event reporting by clinicians. Qual Life Res. 2012 Sep;21(7):1159-64. doi: 10.1007/s11136-011-0031-4. Epub 2011 Oct 8. |
| 18709564 | Background | Fung CH, Hays RD. Prospects and challenges in using patient-reported outcomes in clinical practice. Qual Life Res. 2008 Dec;17(10):1297-302. doi: 10.1007/s11136-008-9379-5. Epub 2008 Aug 18. |
| 23736730 | Background | Conway PH, Mostashari F, Clancy C. The future of quality measurement for improvement and accountability. JAMA. 2013 Jun 5;309(21):2215-6. doi: 10.1001/jama.2013.4929. No abstract available. |
| 40408610 | Derived | Stover AM, Deal AM, Ginos B, Dueck A, Spears PA, Jansen J, Carr P, Henson S, Bennett AV, Jonsson M, Snyder C, Basch E. Impact of Providing an Automated Telephone Option to Report Weekly Patient-Reported Outcome Measures in the PRO-TECT Trial (AFT-39) on Disparity Gaps in Symptom Management and Outcomes. JCO Clin Cancer Inform. 2025 May;9:e2500046. doi: 10.1200/CCI-25-00046. Epub 2025 May 23. |
| 40215451 | Derived | Mody GN, Bennett AV, Stover AM, Jonsson M, Teal R, Vu M, Carda-Auten J, Jansen J, Carr P, Dueck A, Henson S, Basch E. Implementation of Symptom Monitoring With Electronic Patient-Reported Outcomes: Perspectives and Recommendations From Community Oncology Practices (Alliance AFT-39). JCO Oncol Pract. 2025 Dec;21(12):1830-1837. doi: 10.1200/OP-24-00627. Epub 2025 Apr 11. |
| 39920394 | Derived | Basch E, Schrag D, Jansen J, Henson S, Ginos B, Stover AM, Carr P, Spears PA, Jonsson M, Deal AM, Bennett AV, Thanarajasingam G, Rogak L, Reeve BB, Snyder C, Bruner D, Cella D, Kottschade LA, Perlmutter J, Geoghegan C, Given B, Mazza GL, Miller R, Strasser JF, Zylla DM, Weiss A, Blinder VS, Wolf AP, Dueck AC. Symptom monitoring with electronic patient-reported outcomes during cancer treatment: final results of the PRO-TECT cluster-randomized trial. Nat Med. 2025 Apr;31(4):1225-1232. doi: 10.1038/s41591-025-03507-y. Epub 2025 Feb 7. |
| 39503942 | Derived | Lee MK, Mitchell SA, Basch E, Mazza GL, Langlais BT, Thanarajasingam G, Ginos BF, Rogak L, Meek EA, Jansen J, Deal AM, Carr P, Blinder VS, Jonsson M, Mody GN, Mendoza TR, Bennett AV, Schrag D, Dueck AC. Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE(R)). Qual Life Res. 2025 Feb;34(2):495-507. doi: 10.1007/s11136-024-03819-5. Epub 2024 Nov 6. |
| 35661856 | Derived | Basch E, Schrag D, Henson S, Jansen J, Ginos B, Stover AM, Carr P, Spears PA, Jonsson M, Deal AM, Bennett AV, Thanarajasingam G, Rogak LJ, Reeve BB, Snyder C, Bruner D, Cella D, Kottschade LA, Perlmutter J, Geoghegan C, Samuel-Ryals CA, Given B, Mazza GL, Miller R, Strasser JF, Zylla DM, Weiss A, Blinder VS, Dueck AC. Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial. JAMA. 2022 Jun 28;327(24):2413-2422. doi: 10.1001/jama.2022.9265. |
| 33112661 | Derived | Basch E, Stover AM, Schrag D, Chung A, Jansen J, Henson S, Carr P, Ginos B, Deal A, Spears PA, Jonsson M, Bennett AV, Mody G, Thanarajasingam G, Rogak LJ, Reeve BB, Snyder C, Kottschade LA, Charlot M, Weiss A, Bruner D, Dueck AC. Clinical Utility and User Perceptions of a Digital System for Electronic Patient-Reported Symptom Monitoring During Routine Cancer Care: Findings From the PRO-TECT Trial. JCO Clin Cancer Inform. 2020 Oct;4:947-957. doi: 10.1200/CCI.20.00081. |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 3 Month Time Point |
|
|
| 12 Month Time Point |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Education | Count of Participants | Participants |
| ||||||||||||||||
| Urban or Rural Site | Count of Participants | Participants |
| ||||||||||||||||
| Difficulty Paying Bills | Count of Participants | Participants |
| ||||||||||||||||
| Cancer Type | Count of Participants | Participants |
| ||||||||||||||||
| Line of Cancer Therapy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | Unadjusted Kaplan-Meier estimated survival, based on administrative datasets and practice self-report/medical records. | Enrolled eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Physical Functioning | 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. | Patients who completed the QLQ C30 measure at the 3 month time point. | Posted | Count of Participants | Participants | Month 3 |
| |||||||||||||||||||||||||||||||
| Secondary | Symptom Control | 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. | Patients who completed the QLQ-C30 measure at the 3-month time point. | Posted | Count of Participants | Participants | Month 3 |
| |||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life | 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. | Patients who completed the QLQ-C30 measure at the 3-month time point. | Posted | Count of Participants | Participants | Month 3 |
| |||||||||||||||||||||||||||||||
| Secondary | Patient Satisfaction/Communication | 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. | Patients participating in the ePROs arm completed the Patient Feedback Survey to assess patient satisfaction with the system and communication with their care team. | Posted | Number | participants | Month 3 |
| |||||||||||||||||||||||||||||||
| Secondary | Emergency Department Utilization | Data for emergency department visits were obtained from data abstracted at each practice from the electronic medical record. | Enrolled eligible patients | Posted | Count of Participants | Participants | 1 year |
|
|
Participants were assessed for death for up to 2 years.
Dates of death were based on US National Death Index administrative data and confirmed with medical chart abstraction. Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ePRO Intervention | Patients report symptoms weekly. Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence-based symptom management pathways provided to patients and clinicians. | 350 | 593 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 345 | 598 | 0 | 0 | 0 | 0 |
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This study was conducted during the pandemic when research and clinical resources at participating sites were strained with frequent turnover of staff. This disrupted accrual and conduct and likely decreased the effect size observed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | University of North Carolina at Chapel Hill | 9194456223 | symptom_study@unc.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2022 | Jan 18, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Changed oncology practice |
|
| Changed oncology practice |
|
| Male |
|
| Missing |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 9th-11th Grade |
|
| High School Graduate/GED |
|
| Some College, Associate's Degree, Other Certification |
|
| College Degree |
|
| Advanced Degree |
|
| Missing |
|
| Participants at Urban Site |
|
| Not very |
|
| Somewhat |
|
| Very/extremely |
|
| Missing |
|
| Thoracic (Lung, Thyroid, Thymus) |
|
| Breast |
|
| Gyn (Ovarian, Cervix, Uterine, Vaginal) |
|
| Pancreas, Hepatobiliary |
|
| Gastroesophageal, Small bowel |
|
| Genitourinary Non-prostate (Bladder, Kidney, Testicular, Penile) |
|
| Myeloma, Lymphoma |
|
| Prostate |
|
| Melanoma, Skin |
|
| Other (Brain, Sarcoma, Other Soft Tissue, Head/Neck, Unknown Primary) |
|
| 2nd Line |
|
| 3rd Line |
|
| 4th Line |
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|