DOI: 10.3886/icpsr39449.v1
title: PRO-TECT: Electronic Patient Reporting of Symptoms During Outpatient Cancer Treatment, United States, 2017-2022
title: Version 1

description: Patients treated for metastatic cancer, or cancer that has spread to another part of the body, often have symptoms from cancer and its treatment. They may feel tired, depressed, or nauseated. They may find it hard to do their usual activities. Better symptom tracking may help improve patients' care. For example, symptom tracking could quickly alert doctors when a patient may need a different medicine. In this study, the research team compared use of a weekly electronic symptom tracking system versus usual care for patients with cancer. Patients receiving usual care could report their symptoms to their care team during regular clinic visits. The research team wanted to see if the tracking system helped patients live longer, have better quality of life, or go to the hospital or emergency room less often. The aims of this study were as follows:

Determine whether integrating electronic patient-reported outcomes (ePRO) in cancer care improves patient-centered outcomes;
Elicit perspectives about benefit burden tradeoffs for integrating patient-reported outcomes into clinical workflow; and
Identify barriers, facilitators, and strategies used by practices to integrate patient-reported outcomes into clinical workflow.

A total of 1,191 patients were enrolled from 52 U.S.-based community oncology practices. Randomization into intervention and control conditions occurred at the site level. Data collected as part of this study included patient clinical information; weekly symptom surveys, quality of life surveys, and cancer care surveys completed by patients; feedback on the ePRO intervention from patients, clinical research associates, nurses, and physicians; and symptom alerts sent to nursing staff. Please note that while qualitative data were collected as part of this study, they are not available.
description: The main purpose of the study was to evaluate whether electronic patient-reported outcome (ePRO) symptom monitoring during cancer treatment improved patient survival, physical functioning, health-related quality of life, symptom control, and emergency department/hospital visits. Additionally, the researchers sought to elicit feedback from stakeholders (patients, nurses, physicians, and external parties) on barriers/facilitators to ePRO implementation, utility, value, and dissemination strategies.
description: The research team used a multicenter cluster-randomized trial design. Study enrollment occurred between October 30, 2017 and March 16, 2020. Practices randomly assigned to the intervention condition were provided access to an electronic survey system at University of North Carolina PRO Core facility.
Site research managers worked with clinical nurses and oncologists to identify eligible patients through electronic health record review, clinical schedules, or asking clinical staff. Site research personnel or designated clinical staff approached potential patient participants and invited them to enroll.
Patients could choose to complete surveys in their preferred language (English, Spanish, or Mandarin) by web, handheld device, or automated telephone system. Patients across both conditions received $75 as compensation. In both conditions, data were collected at baseline, 1 month, 3 months, 6 months, 9 months, and 12 months. Specific to the intervention condition, patients in the completed weekly surveys for one year (52 weeks) or until they discontinued all cancer treatment. If patients reported symptoms of a specific magnitude or worsening compared to the prior completed survey, a clinical nurse responsible for the patient received an email-based alert notification. Patients also completed surveys gauging their satisfaction with the ePRO system at 3 months and 12 months. Clinical research associates, nurses, and physicians also completed surveys on their experiences with ePRO after at least 6 months of using the system.
In addition to the quantitative survey data and administrative data collections, the research team conducted semi-structured interviews via phone or face-to-face with participating nurses and physicians about their experiences integrating ePROs into their daily workflows. A total of 82 individuals (51 nurses, 31 physicians) across 25 of the 26 intervention sites completed interviews between August 20, 2018 and October 26, 2020.
description: Patient survival was the primary outcome, which was measured by patient date of death (DS3, DS4). Patient records were linked to the National Death Index at the U.S. Centers for Disease Control and Prevention. Participating practices abstracted death dates from health records through month 24 of each patient's enrollment.
Secondary outcomes were physical function, symptom control, health-related quality of life, and emergency department visits. Data for physical function, symptom control, and quality of life were obtained via the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ-C30) questionnaire and other items in weekly patient check-ins (DS6, DS7). Emergency department visit data were abstracted from health records (DS2). Patients were also asked to evaluate their cancer care team using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) scale for cancer care (DS5).
Intervention feedback items focused on whether the patient-reported information and symptom alerts system was helpful, if it improved efficiency and patient care, if the information was used by physicians to make care decisions, and if the respondent would recommend it to others (DS8, DS9, DS10, DS11).
Patient demographics collected include age, sex, race, Hispanic ethnicity, employment status, marital status, and education (DS2). No demographics were collected for healthcare staff respondents.
description: Response Rates: Among intervention arm patients, 20,565 of 22,486 (91.5%) expected weekly surveys were completed without substantial reduction in completion rates over time. 1,066 of 1,098 (97.1%) patients completed the quality of life surveys at 3 months, among those who were expected to complete surveys. At 12 months, 683 patients remained in the study (57.3%).
description: Presence of Common Scales: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
description: Fifty-two community oncology practices in the U.S. national network of the Alliance for Clinical Trials in Oncology (the Alliance) were randomly assigned 1:1 to electronic patient-reported outcome (ePRO) symptom monitoring (intervention) or usual care (control) using permuted blocks with block sizes of 2 or 4 and stratified by rural/urban based on U.S. Census Bureau criteria. Twenty-six sites were randomized to each condition.
Participating practices were asked to enroll up to 50 adults with metastatic cancer of any type that were receiving treatment with chemotherapy, targeted oral therapy, or immunotherapy, and who were able to understand English, Spanish, or Mandarin. Patients who had indolent lymphoma, acute leukemia, or were receiving hormonal monotherapy were excluded. A total of 1,444 patients were approached and 1,191 enrolled (intervention=593, control=598).
description: Datasets: 
DS0: Study-Level Files
DS1: Study Site Data
DS2: Patient Clinical Data
DS3: Follow Up Status Data (All PRO-TECT Forms)
DS4: Follow Up Status Data (Excludes C9 and Weekly Survey Forms)
DS5: Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey Data
DS6: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Survey Data
DS7: Weekly Electronic Patient-Reported Outcome (ePRO) Response Data
DS8: Patient Intervention Feedback Survey Data
DS9: Clinical Research Associate (CRA) Intervention Feedback Survey Data
DS10: Nurse Intervention Feedback Survey Data
DS11: Physician Intervention Feedback Survey Data
DS12: Nurse Alert Data
DS13: Nurse Alert Data (First 51 Weeks)
DS14: Nurse Alert Data (Summary)
DS15: CONSORT Diagram Data
description: Adults with metastatic cancer who were patients of U.S.-based community oncology practices. Smallest Geographic Unit: Rural-urban commuting area (RUCA)
description: telephone audio computer-assisted self interview (TACASI); telephone interview; web-based survey