A 24-hour remote symptom monitoring system, the Advanced Symptom Management system (ASyMS), led to significant improvements in symptom burden and health-related quality of life (QoL) compared to standard care in cancer patients receiving adjuvant chemotherapy, according to results from the international eSMART trial.
These findings suggest that ASyMS and similar technology can “provide a safe, secure, and ’real time’ system” for improving symptom management and supporting patients from the safety of their home—a particularly relevant option in the context of the Covid-19 pandemic, during which safe, distanced care options offer a significant treatment advantage, Roma Maguire, BN, MSc, PhD, of the University of Strathclyde in Glasgow, U.K., and colleagues argued in the BMJ.
While there is ample guidance for patients and health care professionals on managing chemotherapy, treatment-related symptoms are often poorly controlled, setting off a domino effect leading to worse treatment adherence, impaired health-related QoL, increased health service use, and ultimately mortality, Maguire and colleagues explained. But now, with “connected health” solutions on the rise, remote monitoring systems present an attractive alternative to standard care for patients undergoing chemotherapy.
For the eSMART study, Maguire and colleagues compared ASyMS against standard care to assess the impact of remote symptom monitoring on symptom burden, supportive care needs, anxiety, work limitations, health-related QoL, and self-care/self-efficacy in patients undergoing chemotherapy to treat non-metastatic breast cancer, colorectal cancer, Hodgkin’s disease, or non-Hodgkin’s lymphoma at 12 cancer centers in Austria, Greece, Norway, Republic of Ireland, and the U.K.
“The results of eSMART suggest that ASyMS is an effective intervention for reducing symptom burden and improving health related quality of life during adjuvant chemotherapy across a range of cancers,” they reported. “Use of ASyMS was associated with significant reductions in anxiety and improvements in several supportive care needs and self-efficacy domains. Moreover, results were consistent across five European countries, although perhaps with greater impact in Austria, the Republic of Ireland, and the UK. Our success in implementing ASyMS across several diverse health systems suggests that the system can be easily scaled up and adapted for use in various international settings.”
Patients undergoing treatment for breast cancer, Hodgkin’s disease, or non-Hodgkin’s lymphoma saw the greatest improvement, they added.
For this multicenter, repeated measures, parallel group, evaluator masked, stratified randomized control trial, the study authors recruited patients ≥18 years old who were diagnosed with breast cancer, colorectal cancer, Hodgkin’s disease, or non-Hodgkin’s lymphoma and were scheduled to receive at least three cycles of two, three, or four times weekly first-line adjuvant chemotherapy or chemotherapy for the first time in 5 years. Patients were then randomized to either ASyMS (n=415) or standard care (n=414) for up to six cycles of chemotherapy. Mean age was 52.4 years, 81.8% were female, and breast cancer was the most common cancer type (71.4%), with most presenting with early stage (0-II) disease (53.4%). The highest numbers of participants were from the U.K. (31.7%) and Greece (31.2%), and half of patients had no comorbidities.
Participants in the ASyMS group used the system to complete a validated self-reported questionnaire (Daily Chemotherapy Toxicity Self-Assessment [DCTAQ]) assessing 10 symptoms—nausea, vomiting, diarrhea, constipation, mucositis, parasthesias, sore hands or feet, flu-like symptoms/infection, tiredness, or pain—and up to six additional symptoms, as well as to enter their body temperature using a digital thermometer. The DCTAQ was completed daily and whenever the patient felt unwell, and “real-time” data was sent to their health care professional.
“When necessary, ASyMS generated two types of alerts: amber, for persistent mild-moderate symptoms for which early intervention could prevent progression; and red, for chemotherapy emergencies such as neutropenic sepsis,” the researchers explained. “Required response times were eight hours for amber alerts and 30 minutes for red alerts. When an alert was generated before an earlier alert had been dealt with (for example, if the patient completed a subsequent DCTAQ because symptoms had worsened), the alerts were linked.” The alerts were received via dedicated handsets.
Patients in the control group received standard care and were advised to contact their clinician through standard means—usually phone call—if they developed symptoms.
The primary study outcome was symptom burden as assessed by the Memorial Symptom Assessment Scale (MSAS); secondary outcomes included health-related QoL (Functional Assessment of Cancer Therapy—General; FACT-G), the Supportive Care Needs Survey Short-Form (SCNS-SF34, which measures five domains: health system and information, psychological needs, physical and daily living, patient care and support, and sexual related), the State-Trait Anxiety Inventory—Revised (STAI-R, which measures anxiety about an event [state] and as a personal characteristic [trait]), the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer), and a work limitations questionnaire (WLQ).
“For the intervention group, symptom burden remained at pre-chemotherapy treatment levels, whereas controls reported an increase from cycle 1 onwards (least squares absolute mean difference −0.15, 95% confidence interval −0.19 to −0.12; P<0.001; Cohen’s D effect size=0.5),” the study authors found.
Also among the findings:
- Significant reductions in MSAS in favor of ASyMS for global distress index (−0.21, −0.27 to −0.16; P<0.001), psychological symptoms (−0.16, −0.23 to −0.10; P<0.001), and physical symptoms (−0.21, −0.26 to −0.17; P<0.001).
- Higher FACT-G scores in the intervention group for all chemotherapy cycles (mean difference 4.06, 95% confidence interval 2.65 to 5.46; P<0.001).
- Lower scores for STAI-R trait (−1.15, −1.90 to −0.41; P=0.003) and STAI-R state anxiety (−1.13, −2.06 to −0.20; P=0.02).
- Higher CASE-Cancer scores in the intervention (group mean difference 0.81, 0.19 to 1.43; P=0.01).
- Lower scores in most SCNS-SF34 domains, including sexuality needs ((−1.56, −3.11 to −0.01; P<0.05), patient care and support needs (−1.74, −3.31 to −0.16; P=0.03), and physical and daily living needs (−2.8, −5.0 to −0.6; P=0.01). Other SCNS-SF34 domains and WLQ were not significantly different between groups.
Adverse events were balanced across treatment groups, they added, with three deaths occurring in each group. Neutropenic events were higher in the ASyMS group (125 [64%] versus 71 [36%]), a finding which Maguire and colleagues noted was “expected, as remote monitoring sought to identify these.” Planned and unplanned hospital admissions were similar between the two groups. No ASyMS device related incidents were reported.
“Improving symptom management by using remote monitoring systems such as ASyMS is essential,” they study authors concluded. “Future research should combine artificial intelligence with the use of real world data to develop predictive, personalized, and targeted interventions. These approaches are likely to lead to improvements in patients’ outcomes and efficiencies in care. Evaluation of the efficacy of remote symptom monitoring systems such as ASyMS for other treatment modalities (for example, targeted therapies) is needed. The ultimate vision is to have a multimodal seamless system of remote symptom monitoring used from the start of treatment and through survivorship.”
Study limitations included that three quarters of participants were females with breast cancer and that the study authors “encountered technical challenges across all sites owing to the connectivity of ASyMS SIM cards, meaning that patients using ASyMS reverted to standard care for approximately two weeks to ensure patient safety while this technical problem was resolved. Although technical testing indicated that this was not related to the ASyMS device, it may have affected overall eSMART results.”
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The eSMART trial found that a 24-hour remote symptom monitoring system, the Advanced Symptom Management system (ASyMS), led to significant improvements in symptom burden and health-related quality of life (QoL) compared to standard care in cancer patients receiving adjuvant chemotherapy.
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These findings suggest that ASyMS and similar technology can “provide a safe, secure, and ’real time’ system” for improving symptom management and supporting patients from the safety of their home and is therefore a relevant option in the context of the Covid-19 pandemic.
John McKenna, Associate Editor, BreakingMED™
Maguire and colleagues delcared financial support from the European Commission for the submitted work.
Cat ID: 22
Topic ID: 78,22,728,791,730,22,23,467,935,192,925
