Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Mar;6(3):537-546.
doi: 10.1002/cam4.1002. Epub 2017 Jan 30.

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

Affiliations
Randomized Controlled Trial

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

Kathi H Mooney et al. Cancer Med. 2017 Mar.

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.

Trial registration: ClinicalTrials.gov NCT01973946.

Keywords: Chemotherapy; decision support systems; eHealth; evidence-based clinical practice guidelines; patient-reported outcomes; symptom management; telehealth.

PubMed Disclaimer

Figures

Figure 1
Figure 1
CONSORT 1 Flow Diagram
Figure 2
Figure 2
Daily values for total symptom severity summed across all 11 symptoms

References

    1. Basch, E. , Iasonos A., Barz A., et al. 2007. Long‐term toxicity monitoring via electronic patient‐reported outcomes in patients receiving chemotherapy. J. Clin. Oncol. 25:5374–5380. - PubMed
    1. Berry, D. L. , Blumenstein B. A., Halpenny B., et al. 2011. Enhancing patient‐provider communication with the electronic self‐report assessment for cancer: a randomized trial. J. Clin. Oncol. 29:1029–1035. - PMC - PubMed
    1. Berry, D. L. , Hong F., Halpenny B., et al. 2014a. The electronic self report assessment and intervention for cancer: promoting patient verbal reporting of symptom and quality of life issues in a randomized controlled trial. BMC Cancer 14:513. - PMC - PubMed
    1. Berry, D. L. , Hong F., Halpenny B., et al. 2014b. Electronic self‐report assessment for cancer and self‐care support: results of a multicenter randomized trial. J. Clin. Oncol. 32:199–205. - PMC - PubMed
    1. Cleeland, C. S. , Wang X. S., Shi Q., et al. 2011a. Automated symptom alerts reduce postoperative symptom severity after cancer surgery: a randomized controlled clinical trial. J. Clin. Oncol. 29:994–1000. - PMC - PubMed

Publication types

Substances

Associated data