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Background Relapsed and refractory multiple myeloma (RRMM) is a bone marrow cancer that requires systemic treatment, which often results in severe symptom burden. Recent studies have found that electronic patient-reported outcome (ePRO) interventions implemented in the clinic setting have had positive outcomes for other oncology populations. Evidence of the efficacy of a similar approach is lacking for patients with RRMM. Objective Recent recommendations for digital health interventions call for the publication of descriptions of iterative development processes in order to improve reproducibility and comparability. This study is an implementation pilot aiming to evaluate the acceptability and appropriateness of an ePRO intervention for patients with RRMM and to explore its impact on clinic workflow. Methods A total of 11 patients with RRMM were recruited from the John Theurer Cancer Center in Hackensack, New Jersey. Patients used a mobile app to report on 17 symptoms at 4 sessions, each a week apart. Patients could also report symptoms ad hoc. When reports met predefined thresholds, the clinic was alerted and patients received automated guidance. Study end points were assessed using qualitative and quantitative methods. Results A total of 9 patients (mean age 69.7 years) completed the study. Overall, 83% (30/36) of weekly sessions were completed. Patients found the frequency and time required to complete reporting acceptable. All patients agreed that the app was easy to use and understand. Providers felt the alerts they received required refinement. Patients and providers agreed it would be beneficial for patients to report for longer than 4 weeks. Patients felt that the training they received was adequate but contained too much information for a single session. All patients found the symptoms tracked to be appropriate; providers suggested shortening the list. All patients understood how to use the app for weekly reporting but had confusion about using it ad hoc. Providers felt the ad hoc feature could be removed. Neither patients nor providers viewed the in-app data reports but agreed on their potential value. Patients reported benefitting from symptom reporting through increased awareness of their symptoms. Clinic staff reported that app alerts were too numerous and redundant. They had difficulty responding to alerts within their existing workflow, partially because the data were not integrated into the electronic medical record system. Conclusions Overall, the intervention was found to be acceptable and appropriate for patients with RRMM. Points of friction integrating the intervention into the clinic workflow were identified. Clinic staff provided recommendations for addressing these issues. Once such modifications are implemented, ePRO data from patients with RRMM could be used to inform and improve clinical research and care. This study underlines the importance of an iterative approach to implementation that includes all stakeholders in order to ensure successful adoption.

Background Treatment for head and neck cancer (HNC) may cause substantial local and systemic symptomatic morbidities, but many patients have high symptom levels before treatment begins. Knowledge of disease-related (treatment-naive) symptom status would aid evaluation of the symptomatic benefit or burden of HNC therapies. Methods We retrospectively examined symptoms, quality of life, and health status reported by HNC patients who were naïve to any treatment. We explored symptoms by anatomical site and correlated disease factors with symptom severity and interference. We used a clustering algorithm to identify a subset of highly symptomatic patients and examined the effects of disease site, tumor stage, and demographic variables on membership in this high-symptom group. Results We identified 748 treatment-naïve patients with mucosal (n=434), nonmucosal (n=272), or skull-base (n=42) tumors who had rated symptoms using the MD Anderson Symptom Inventory. Most were white non-Hispanic (82%) and male (68%) with a median age of 59 years. Approximately one third had high pretreatment symptom burden. Pain, fatigue, distress, and disturbed sleep were the most-severe symptoms, regardless of tumor stage or site. Symptom burden was higher in patients with more-advanced disease. Predictors of high symptom burden included having a mucosal tumor and being female. Conclusions The high prevalence of moderate-to-severe symptoms in this study demonstrates the importance of assessing patient-reported symptoms routinely before treatment is initiated and emphasizes the need for symptom management in parallel with disease treatment. Baseline characterization of symptom status should be incorporated into clinical trials that may affect symptom burden.

The aim of this study was to evaluate spinal accessory nerve function after functional neck dissection (FND) and radical neck dissection (RND) by monitoring the nerve with electromyographic (EMG) examinations. A prospective, double-blind, clinical study was undertaken in 21 patients (42 neck side dissections) operated on for head and neck malignant diseases, separated into two groups: 10 neck sides in the RND group and 32 neck sides in the FND group. Electromyographic examinations were performed pre-operatively and post-operatively in the third week and third and ninth months. Additionally, a questionnaire, modified from the neck dissection impairment index, was applied to all the patients in order to assess shoulder function in the ninth post-operative month. All patients had maximum EMG scores pre-operatively. Following the operation, motor amplitudes decreased in both groups. At the third post-operative month, amplitudes decreased to their lowest values. As expected, the decreases in amplitude and EMG score were more prominent in the RND group. Following reinnervation, the amplitudes of the trapezius motor response increased in the FND group but never reached pre-operative values (during the time of follow up). The FND group scores for pain, neck and shoulder stiffness, and disability in heavy object lifting, light object lifting and reaching overhead were significantly lower than those of the RND group. In FND, one aims to preserve anatomically the spinal accessory nerve, and it is presumed to be intact after the procedure. However, using EMG nerve function monitoring, our study revealed that profound spinal nerve injury was detected immediately after FND surgery, which tended to improve over subsequent months but had not regained its original function by the end of the ninth post-operative month.

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