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Automated home monitoring and management of patient-reported symptoms during chemotherapy: results of the symptom care at home RCT.

ABSTRACT: Technology-aided remote interventions for poorly controlled symptoms may improve cancer symptom outcomes. In a randomized controlled trial, the efficacy of an automated symptom management system was tested to determine if it reduced chemotherapy-related symptoms. Prospectively, 358 patients beginning chemotherapy were randomized to the Symptom Care at Home (SCH) intervention (n = 180) or enhanced usual care (UC) (n = 178). Participants called the automated monitoring system daily reporting severity of 11 symptoms. SCH participants received automated self-management coaching and nurse practitioner (NP) telephone follow-up for poorly controlled symptoms. NPs used a guideline-based decision support system. Primary endpoints were symptom severity across all symptoms, and the number of severe, moderate, mild, and no symptom days. A secondary endpoint was individual symptom severity. Mixed effects linear modeling and negative binominal regressions were used to compare SCH with UC. SCH participants had significantly less symptom severity across all symptoms (P < 0.001). On average, the relative symptom burden reduction for SCH participants was 3.59 severity points (P < 0.001), roughly 43% of UC. With a very rapid treatment benefit, SCH participants had significant reductions in severe (67% less) and moderate (39% less) symptom days compared with UC (both P < 0.001). All individual symptoms, except diarrhea, were significantly lower for SCH participants (P < 0.05). Symptom Care at Home dramatically improved symptom outcomes. These results demonstrate that symptoms can be improved through automated home monitoring and follow-up to intensify care for poorly controlled symptoms.

SUBMITTER: Mooney KH

PROVIDER: S-EPMC5345623 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Automated home monitoring and management of patient-reported symptoms during chemotherapy: results of the symptom care at home RCT.

Mooney Kathi H KH Beck Susan L SL Wong Bob B Dunson William W Wujcik Debra D Whisenant Meagan M Donaldson Gary G

Cancer medicine 20170130 3

Technology-aided remote interventions for poorly controlled symptoms may improve cancer symptom outcomes. In a randomized controlled trial, the efficacy of an automated symptom management system was tested to determine if it reduced chemotherapy-related symptoms. Prospectively, 358 patients beginning chemotherapy were randomized to the Symptom Care at Home (SCH) intervention (n = 180) or enhanced usual care (UC) (n = 178). Participants called the automated monitoring system daily reporting sever ...[more]

PMID: 28135050

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Project description:ContextClinical guidelines are available to enhance symptom management during cancer treatment but often are not used in the practice setting. Clinical decision support can facilitate the implementation and adherence to clinical guidelines. and improve the quality of cancer care.ObjectivesClinical decision support offers an innovative approach to integrate guideline-based symptom management into oncology care. This study evaluated the effect of clinical decision support-based recommendations on clinical management of symptoms and health-related quality of life (HR-QOL) among outpatients with lung cancer.MethodsTwenty providers and 179 patients were allotted in group randomization to attention control (AC) or Symptom Assessment and Management Intervention (SAMI) arms. SAMI entailed patient-report of symptoms and delivery of recommendations to manage pain, fatigue, dyspnea, depression, and anxiety; AC entailed symptom reporting prior to the visit. Outcomes were collected at baseline, two, four and six-months. Adherence to recommendations was assessed through masked chart review. HR-QOL was measured by the Functional Assessment of Cancer Therapy-Lung questionnaire. Descriptive statistics with linear and logistic regression accounting for the clustering structure of the design and a modified chi-square test were used for analyses.ResultsMedian age of patients was 63 years, 58% female, 88% white, and 32% ≤high school education. Significant differences in clinical management were evident in SAMI vs. AC for all target symptoms that passed threshold. Patients in SAMI were more likely to receive sustained-release opioids for constant pain, adjuvant medications for neuropathic pain, opioids for dyspnea, stimulants for fatigue and mental health referrals for anxiety. However, there were no statistically significant differences in HR-QOL at any time point.ConclusionSAMI improved clinical management for all target symptoms but did not improve patient outcomes. A larger study is warranted to evaluate effectiveness.

Project description:For ethical and legal reasons it is necessary to assess the severity of procedures in animal experimentation. To estimate the degree of pain, suffering, distress or lasting harm, objective methods that provide gradebale parameters need to be tested and validated for various models. In this context, automated home-cage monitoring becomes more important as a contactless, objective, continuous and non-invasive method. The aim of this study was to examine a recently developed large scale automated home-cage monitoring system (Digital Ventilated Cage, DVC®) with regard to the applicability and added value for severity assessment in a frequently used acute colitis mouse model. Acute colitis was induced in female C57BL/6J mice by varying doses of DSS (1.5 and 2.5%), matched controls received water only (0%). Besides DVC® activity monitoring and nest scoring, model specific parameters like body weight, clinical colitis score, and intestinal histo-pathology were used. In a second approach, we questioned whether DVC® can be used to detect an influence of different handling methods on the behavior of mice. Therefore, we compared activity patterns of mice that underwent tunnel vs. tail handling for routine animal care procedures. In DSS treated mice, disease specific parameters confirmed induction of a graded colitis. In line with this, DVC® revealed reduced activity in these animals. Furthermore, the system displayed stress-related activity changes due to the restraining procedures necessary in DSS-treatment groups. However, no significant differences between tunnel vs. tail handling procedures were detected. For further analysis of the data, a binary classifier was applied to categorize two severity levels (burdened vs. not burdened) based on activity and body weight. In all DSS-treatment groups data points were allocated to the burdened level, in contrast to a handling group. The fraction of "burdened" animals reflected well the course of colitis development. In conclusion, automated home-cage monitoring by DVC® enabled severity assessment in a DSS-induced colitis model equally well as gold standard clinical parameters. In addition, it revealed changes in activity patterns due to routine handling procedures applied in experimental model work. This indicates that large scale home-cage monitoring can be integrated into routine severity assessment in biomedical research.

Project description:PurposeWe evaluated the feasibility of patient symptom self-reporting using a web-based interface (WBI), with automated message alerts for severe and/or worsening symptoms, in patients undergoing definitive chemoradiation therapy (CRT).Methods and materialsPatients receiving definitive CRT for gastrointestinal, lung, and head and neck cancers with access to a computer and/or mobile device were eligible. Symptom self-reporting was conducted via a WBI through surveys adapted from the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events: 2 per week during CRT and 1 per week for 3 months after CRT. Nurses were alerted whenever a patient's symptom worsened by ≥2 points or reached a score of ≥3. Patient-Reported Outcomes Measurement Information System (PROMIS) surveys were conducted at baseline, end of CRT, and 3 months after CRT. Patients also completed exit surveys 3 months after CRT.ResultsNineteen patients were enrolled with a median of 30 fractions (range, 28-33). The median survey completion rate was 26% (range, 0%-100%) during CRT and 33% (range, 0%-100%) during the first 3 months after CRT. Five (26%) had acute hospital encounters during CRT or within 3 months of CRT completion. Two patients (11%) experienced CRT treatment interruptions. During CRT, 70 of 81 surveys (86%) were flagged and 61 of 70 (87%) were acted upon by a nurse or physician within 4 days; during the first 3 months after CRT, 47 of 85 (55%) were flagged and 28 of 47 (60%) were acted upon within 7 days. Ninety-two percent of patients found it always easy to access the survey while 58% found the surveys too long or too frequent. None of the PROMIS domains had statistically significant changes during any time points.ConclusionsSymptom self-reporting via a WBI is feasible during definitive chemoradiation with high patient satisfaction. Survey fatigue is common and may be mitigated by improving the WBI to make it more patient-centered and allowing patients to choose which symptoms to report.

Dataset Information

Automated home monitoring and management of patient-reported symptoms during chemotherapy: results of the symptom care at home RCT.

Publications

Automated home monitoring and management of patient-reported symptoms during chemotherapy: results of the symptom care at home RCT.

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