Electronic Patient Reporting of Symptoms During Cancer Treatment
- Conditions
- Metastatic Cancer
- Interventions
- Other: Patient Self-Reporting of SymptomsOther: Usual Care Delivery
- Registration Number
- NCT03249090
- Lead Sponsor
- Alliance Foundation Trials, LLC.
- Brief Summary
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.
- Detailed Description
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):
* Site staff (CRA and Nurse Champion required) will attend the site initiation webinar with UNC staff, including training for the PRO-Core online data management system and orientation to the symptom management guidelines.
* At enrollment, all participants will be given a booklet with patient-level symptom advice and a link to the content online.
* All participants will receive compensation for participation, mailed to them as gift cards by UNC.
* CRAs will train all participants how to complete outcomes questionnaires for the trial using the PRO-Core online system. Participants will be given a choice to complete these in clinic or from home online, or if necessary via paper in clinic (with the CRA entering the data into PRO-Core). If the patient does not self-complete this information, the CRA will contact them to collect the information and then enter it into PRO-Core. The outcomes questionnaires will be completed at baseline; and at month 1 (+/- 2 weeks); and at months 3, 6, 9, and 12/off-study (+/- 4 weeks each), and will be available in English, Spanish, or Mandarin Chinese. At each time point, the CRA will contact the participant to remind them about the upcoming questionnaire and offer help.
* Chart abstraction will be conducted by CRAs at baseline and at off-study for each participant, with data entered into the PRO-Core system. Date of death information will additionally be abstracted at 18 and 24 months, and possibly later per the UNC study team.
* CRAs will be asked to complete a feedback survey (entered by the CRA into the PRO-Core online system) and may be asked to participate in a brief telephone debriefing and/or site visit.
* Accrual will be monitored in a weekly teleconference between the UNC team and site CRAs.
ADDITIONAL PROCEDURES AT INTERVENTION SITES ONLY:
* At baseline, CRAs will also train patients to self-report symptoms and physical functioning using the PRO-Core system weekly for up to a year, with a choice to do this online or via an automated telephone system (patient choice), and a choice of English, Spanish, or Mandarin Chinese.
* Whenever a concerning symptom is reported, an automated "email alert" notification will be sent to the site CRA. The CRA will forward the email 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1197
- Adults (21+) with metastatic cancer of any type (EXCEPT leukemia or indolent [slow growing] lymphoma)
- Receiving outpatient systemic cancer treatment for non-curative/palliative intent, including chemotherapy, targeted therapy, or immunotherapy.
- Enrolled at any point in their treatment trajectory, meaning during any line of treatment, and at any point during a course or cycle of treatment.
- Can understand English, Spanish, and/or Mandarin Chinese.
- Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
- Current participation in a therapeutic clinical trial (because these often involve PRO questionnaires and intensive monitoring).
- Patients being treated with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer; primary curative therapy for testis cancer or lymphoma).
- Receiving hormonal therapy only (e.g., tamoxifen or aromatase inhibitors in breast cancer; androgen deprivation therapy in prostate cancer; or octreotide in neuroendocrine cancers)
- Indolent lymphomas (due to their prolonged time courses that may be minimally symptomatic).
- Leukemias (time courses inconsistent with other tumor types in chronic and acute leukemias).
- Does not understand English, Spanish, or Mandarin Chinese.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient Self-Reporting of Symptoms Patient Self-Reporting of Symptoms 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 Usual Care Delivery Evidence-based symptom management pathways provided to patients and clinicians
- Primary Outcome Measures
Name Time Method Overall Survival 24 months Unadjusted Kaplan-Meier estimated survival, based on administrative datasets and practice self-report/medical records.
- Secondary Outcome Measures
Name Time Method Physical Functioning Month 3 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.Symptom Control Month 3 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.Health-related Quality of Life Month 3 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.Patient Satisfaction/Communication Month 3 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.
Emergency Department Utilization 1 year Data for emergency department visits were obtained from data abstracted at each practice from the electronic medical record.
Trial Locations
- Locations (45)
Hematology Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Franciscan Health Indianapolis
🇺🇸Indianapolis, Indiana, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Columbus NCI Community Oncology Research Program
🇺🇸Columbus, Ohio, United States
Illinois CancerCare-Peoria
🇺🇸Peoria, Illinois, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Union Hospital
🇺🇸Terre Haute, Indiana, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Medical Oncology and Hematology Associates-Des Moines
🇺🇸Des Moines, Iowa, United States
Montefiore Medical Center/ Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
St. Joseph Mercy Ann Arbor Hospital
🇺🇸Ypsilanti, Michigan, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
🇺🇸Springfield, Missouri, United States
Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Quincy Medical Group
🇺🇸Quincy, Illinois, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Meritus Medical Center
🇺🇸Hagerstown, Maryland, United States
New Hampshire Oncology Hematology PA-Hooksett
🇺🇸Hooksett, New Hampshire, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Metro Minnesota Community Oncology Research Consortium
🇺🇸Saint Louis Park, Minnesota, United States
Nevada Cancer Specialists
🇺🇸Las Vegas, Nevada, United States
Rex Cancer Center
🇺🇸Raleigh, North Carolina, United States
Bozeman Health Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
WellSpan Health - York Cancer Center
🇺🇸York, Pennsylvania, United States
Centra Lynchburg Hematology Oncology Clinic
🇺🇸Lynchburg, Virginia, United States
Saint Vincent Hospital Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Edwards Comprehensive Cancer Center
🇺🇸Huntington, West Virginia, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University of Iowa Healthcare Cancer Services Quad Cities
🇺🇸Bettendorf, Iowa, United States
Lowell General Hospital
🇺🇸Lowell, Massachusetts, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Oncology Associates at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Grand Valley Oncology
🇺🇸Grand Junction, Colorado, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States