University of Utah
Salt Lake City, Utah, 84112, United States
NCT Number: NCT02779725
This project will determine the most important and cost effective components of SymptomCare@Home, a new approach to cancer chemotherapy symptom care that has been shown to reduce problematic symptoms through automated daily monitoring, self-management coaching, and oncology team follow-up care using decisional support for patients at home when their symptoms are most likely at their worse. Once the key parts of the intervention and its cost effectiveness are known, it can be moved into everyday cancer care.
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Notify MeCancer patients receiving chemotherapy experience multiple poorly controlled symptoms at home in the interim weeks between clinic visits and the next infusion. Their care during this interim time period is suboptimal. Technology can be utilized to bridge the gap between patient symptom needs at home and oncology team response. Automated patient-reported symptom home monitoring and management systems offer a new approach to symptom care. Our research team has developed and tested SymptomCare@Home (SCH). This multi-component automated system monitors daily patient-reported symptoms at home, provides tailored automated self-management coaching based on the specific symptoms reported and transmits unrelieved symptom alert reports to an oncology provider who, using the SCH decision support system provides follow-up telephone-delivered symptom care. We have demonstrated that SCH dramatically reduces physical and psychological symptom severity. However there remain several gaps in translating a successful, multi-component symptom intervention into clinical practice. These include understanding 1) the contribution and value of each part of the intervention so that the active components are selected for clinical implementation and 2) the costs associated with the intervention and its components. Therefore the aims of this project are to deconstruct the SCH symptom monitoring and management system to determine the relative contribution and costs of its components to achieving symptom reduction, maintain general health functioning and reduce healthcare utilization. We will also examine who benefits most and least from the individual components and from the overall system. A 5 group randomized control trial design will be utilized with 750 participants (150/group) beginning a new course of chemotherapy who will call the SCH system daily and report the presence and severity of 11 symptoms throughout a course of chemotherapy or up to 6 months. This study is both significant and innovative because it shifts the current clinical practice paradigm for providing symptom care episodically during clinic visits to an innovative approach that is patient-centric, providing symptom care when and where the patient needs it. The study will address questions not generally asked in multi-component interventions, determining the active ingredients and their costs. Determining the value of new approaches to care such as automated telehealth interventions is essential to the decision process of healthcare systems and payers who decide what to adopt and reimburse. It is also vitally important to patients so that new symptom care innovations are adopted that better meet their needs and dramatically reduce their symptoms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Automated self-management coaching paired to symptom reports during daily symptom monitoring call
Other names: Self-Management Coaching
Alerts generate if a patient reports symptoms above pre-set thresholds during daily symptom reporting calls . These alerts are monitored and follow up is given by a Nurse Practitioner.
Other names: Nurse Practitioner Follow Up
A Clinical Decision Support System (DSS), based on evidenced based guidelines, will be used to assist the nurse practitioner in follow up to symptom alerts.
Other names: Clinical Decision Support System
An activity tracker will be provided to evaluate its use, acceptability and impact on fatigue severity. The purpose of providing the activity tracker is to extend the self-management coaching intervention given when participants report fatigue and receive coaching about exercise as part of the intervention.
Other names: Activity Tracker
Automated patient-reporting of 11 common cancer treatment symptoms
Other names: Patient Reported Symptom Severity
Time frame: up to 6 months
During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.
Time frame: up to 6 months
This will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 + 2 items from the PROMIS 10 (92-95)
Time frame: up to 6 months
For patients who indicated they worked during their treatment, the system asked daily if they missed work if it was a regular workday.
Time frame: up to 6 months
The 25 item patient-reported Work Limitations Questionnaire will be used to measure work performance.
Time frame: up to 6 months
Each week patients reported during their daily phone calls whether or not they had been in contact with a health care provider, were seen in an emergency department or urgent care facility, or had an unscheduled hospitalization. If they reported they did have a medical encounter, the research staff would call and conduct a short telephone interview to collect data about the nature of the medical encounter including whether the medical encounter was related to the symptoms being monitored.
Time frame: Baseline
We will measure baseline physical activity using the 3 item Godin's Leisure-Time Exercise Questionnaire
Time frame: up to 6 months
An End of Study Telephone Interview will be conducted at the end of a patient's participation in the project to obtain data on patient satisfaction with the symptom monitoring system and to obtain suggestions for improvement of the system.
University of Utah
Other
SymptomCare@Home (SCH): Deconstructing an Effective, Technology-assisted, Symptom Management Intervention
Acronym: SCH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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