Benefits of Digital Symptom Monitoring with Patient-Reported Outcomes during Adjuvant Cancer Treatment

Digital symptom monitoring via electronic patient-reported outcomes (PROs) has been demonstrated in prospective randomized trials and population research to improve outcomes for adults with metastatic cancer receiving systemic treatment, including symptom control, quality of life, emergency department visits, time on treatment, and survival. Catching symptoms early via this strategy enables care teams to intervene early and avert preventable downstream complications. It is well-established that up to half of patients’ symptoms go undetected by providers, and digital monitoring bridges this gap

Population-level evidence of survival benefits of patient-reported outcome symptom monitoring software systems in routine cancer care

Symptom management is a cornerstone of quality oncology care. Most patients with cancer experience debilitating symptoms related to the disease itself or to treatment toxicities. If symptoms are not detected early enough, they can worsen and lead to unnecessary suffering, avoidable hospital services, and even death. Numerous prior studies have shown that up to half of patients' symptoms go undetected by their care teams. There is therefore a substantial opportunity to improve symptom detection and early interventions to avoid downstream complications and improve outcomes

Electronic patient-reported outcomes as digital therapeutics to improve cancer outcomes

Among patients receiving treatment for advanced cancers, symptoms are common and frequently cause distress, functional impairment, and emergency room visits. Yet cancer patients’ symptoms often go undetected and unaddressed by clinicians. There is growing international interest in integrating electronic patient-reported outcomes (PROs) into routine practice as digital therapeutics that can increase detection and inform management of symptoms, thereby improving health outcomes and patient experiences and avoiding preventable hospital use

Methods for Implementing and Reporting Patient-reported Outcome (PRO) Measures of Symptomatic Adverse Events in Cancer Clinical Trials

Purpose There is increasing interest to use patient-reported outcome (PRO) measures to evaluate symptomatic adverse events (AEs) in cancer treatment trials. However, there are currently no standard recommended approaches for integrating patient-reported AE measures into trials. Methods Approaches are identified from previous trials for selecting AEs for solicited patient reporting, administering patient-reported AE measures, and analyzing and reporting results. Findings Approaches for integrating patient-reported AE measures into cancer trials generally combine current standard methods for clinician-reported AEs and established best practices for using PRO measures. Specific AEs can be selected for a PRO questionnaire based on common and expected reactions in a given trial context, derived from literature review and qualitative/mixed-methods evaluations and should be the same set administered across all arms of a trial. A mechanism for collecting unsolicited patient-reported AEs will also ideally be included. Patients will preferably report at baseline and at the end of active treatment as well as on a frequent standardized schedule during active treatment, such as weekly from home, with a recall period corresponding to the frequency of reporting (eg, past 7 days). Less frequent reporting may be considered after an initial intensive monitoring period for trials of prolonged treatments and during long-term follow-up. Electronic PRO data collection is preferred. Backup data collection for missed PRO reports is advisable to boost response rates. Analysis can use a combination of approaches to AE and PRO data. If a high proportion of patients is experiencing baseline symptoms, systematic subtraction of these from on-study AEs should be considered to improve reporting of symptoms related to treatment. More granular longitudinal analyses of individual symptoms can also be useful. Implications Methods are evolving for integrating patient-reported symptomatic AEs into cancer trials. These methods are expected to further evolve as more data from trials become available

Clinician vs Patient Reporting of Baseline and Postbaseline Symptoms for Adverse Event Assessment in Cancer Clinical Trials

Many patients enter cancer clinical trials with baseline symptoms. Notably, the current clinician reporting mechanism for symptomatic adverse events (AEs) via the Common Terminology Criteria for Adverse Events (CTCAE) does not formally distinguish between symptoms present at baseline vs those that develop during a trial. Therefore, AE estimation in clinical trials may include symptoms that predate trial entry. This raises concern that the cumulative incidence of patient-reported AEs may be high, particularly if preexisting symptoms related to other causes (eg, comorbidities, prior treatment) are attributed to study drugs

Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment

Symptoms are common among patients receiving treatment for advanced cancers, yet are undetected by clinicians up to half the time. There is growing interest in integrating electronic patient-reported outcomes (PROs) into routine oncology practice for symptom monitoring, but evidence demonstrating clinical benefit has been limited

What Do “None,” “Mild,” “Moderate,” “Severe,” and “Very Severe” Mean to Patients With Cancer? Content Validity of PRO-CTCAE™ Response Scales

Accurate capture of the symptom experience is essential to gauging efficacy, safety, and tolerability of cancer treatments. The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed by the National Cancer Institute to allow direct patient self-reporting of symptomatic adverse events in cancer clinical trials. Its content validity has been established in accordance with recommended practices for novel patient-reported outcome (PRO) instruments

Electronic patient-reported outcomes monitoring during lung cancer chemotherapy: A nested cohort within the PRO-TECT pragmatic trial (AFT-39)

Objectives: Patients with lung cancer have high symptom burden and diminished quality of life. Electronic patient-reported outcome (PRO) platforms deliver repeated longitudinal surveys via web or telephone to patients and alert clinicians about concerning symptoms. This study aims to determine feasibility of electronic PRO monitoring in lung cancer patients receiving treatment in community settings. Methods: Adults receiving treatment for advanced or metastatic lung cancer at 26 community sites were invited to participate in a prospective trial of weekly electronic PRO symptom monitoring for 12 months (NCT03249090). Surveys assessing patients’ satisfaction with the electronic PRO system were administered at 3 months. Descriptive statistics were generated for demographics, survey completion rates, symptom occurrence, and provider PRO alert management approaches. Pairwise relationships between symptom items were evaluated using intra-individual repeated-measures correlation coefficients. Results: Lung cancer patients (n = 118) participating in electronic PROs were older (mean 64.4 vs 61.9 years, p = 0.03), had worse performance status (p = 0.002), more comorbidities (p = 0.02), and less technology experience than patients with other cancers. Of delivered weekly PRO surveys over 12 months, 91% were completed. Nearly all (97%) patients reported concerning (i.e., severe or worsening) symptoms during participation, with 33% of surveys including concerning symptoms. Pain was the most frequent and longest lasting symptom and was associated with reduced activity level. More than half of alerts to clinicians for concerning symptoms led to intervention. The majority (87%) would recommend using electronic PRO monitoring to other lung cancer patients. Conclusions: Remote longitudinal weekly monitoring of patients with lung cancer using validated electronic PRO surveys was feasible in a multicenter, community-based pragmatic study. A high symptom burden specific to lung cancer was detected and clinician outreach in response to alerts was frequent, suggesting electronic PROs may be a beneficial strategy for identifying actionable symptoms and allow opportunities to optimize well-being in this population

An Exploratory Analysis of the “Was It Worth It?” Questionnaire as a Novel Metric to Capture Patient Perceptions of Cancer Treatment

Objectives: Asking “Was it worth it?” (WIWI) potentially captures the patient perception of a treatment's benefit weighed against its harms. This exploratory analysis evaluates the WIWI questionnaire as a metric of patients’ perspectives on the worthwhileness of cancer treatment. Methods: A 3-item WIWI questionnaire was assessed at end of treatment in patients with cancer on the COMET-2 trial (NCT01522443). WIWI items were evaluated to determine their association with quality of life (QOL), treatment duration, end-of-treatment reason, patient-reported adverse events (AEs), and disease response. Results: A total of 65 patients completed the questionnaire; 40 (62%), 16 (25%), and 9 (14%) patients replied yes, uncertain, and no to “Was it worthwhile for you to receive the cancer treatment given in this study?” (item 1), respectively; 39 (60%), 12 (18%), and 14 (22%) to “If you had to do it over again, would you choose to have this cancer treatment?”; and 40 (62%), 14 (22%), and 11 (17%) to “Would you recommend this cancer treatment to others?” Patients responding yes to item 1 remained on treatment longer than those responding uncertain or no (mean 23.0 vs 11.3 weeks, P<.001). Patients responding uncertain/no to item 1 discontinued treatment because of AEs more frequently than those responding yes (36% vs 7.5%, P=.004) and demonstrated meaningful decline in QOL from baseline (−2.5 vs −0.2 mean change, P<.001). Associations between WIWI responses and most patient-reported AEs or treatment efficacy did not reach statistical significance. Conclusions: Patients who responded affirmatively on WIWI items remained on therapy longer, were less likely to stop treatment because of AEs, and demonstrated superior QOL. The WIWI may inform clinical practice, oncology research, and value frameworks