SymptomCare@Home: Deconstructing an Effective Symptom Management Intervention

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Nurse Practitioner; Behavioral: SCC; Behavioral: Symptom Severity; Behavioral: DSS; Behavioral: AT

• Registration Number: NCT02779725
• Lead Sponsor: University of Utah

Brief Summary

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.

Detailed Description

Cancer 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.

Study Timeline

• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-20
• Study Start: 2017-08-07
• Primary Completion: 2020-03-31
• Study Completion: 2022-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 884

Inclusion Criteria

• Histological diagnosis of cancer
• Life expectance of at least three months
• Beginning a new course of chemotherapy that is planned for a minimum of three cycles
• English speaking
• Daily access to a telephone
• Cognitively capable to use the phone unassisted as verified by study staff at recruitment
• Receiving care under the direction of one of the designated provider teams at Huntsman Cancer Institute (SLC, UT) or Grady Cancer Institute (Atlanta, GA).

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Exclusion Criteria

• Receiving concurrent radiation therapy
• Exclusively receiving biotherapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 1 SCC/SSR	Symptom Severity	This arm includes self-care coaching (SCC) message during daily self-reported symptom severity report (SSR) calls to the automated system.
Group 2 NP/SSR	Nurse Practitioner	Alert reports are generated during the patient's daily symptom severity monitoring call if alert thresholds are reached. These alerts are monitored and follow-up care is given by a nurse practitioner.
Group 1 SCC/SSR	SCC	This arm includes self-care coaching (SCC) message during daily self-reported symptom severity report (SSR) calls to the automated system.
Group 3 NP/DSS/SSR	DSS	Alert reports are generated during the patient's daily symptom severity monitoring call if alert thresholds are reached. Nurse practitioner follow-up calls utilize the evidenced based SCH decision support system (DSS) when symptoms exceed alert thresholds
Group 5 SSR/SCC/AT	AT	Symptom severity reporting (SSR), automated self-care coaching (SCC) based on daily symptom reporting plus activity tracker (AT)
Group 2 NP/SSR	Symptom Severity	Alert reports are generated during the patient's daily symptom severity monitoring call if alert thresholds are reached. These alerts are monitored and follow-up care is given by a nurse practitioner.
Group 4 Full Intervention SSR/SCC/NP/DSS	SCC	Complete intervention with all components used in prior efficacy study (Symptom Severity Report (SSR)+Self Care Coaching (SCC) +Nurse Practitioner (NP) +Decision Support System (DSS))
Group 4 Full Intervention SSR/SCC/NP/DSS	DSS	Complete intervention with all components used in prior efficacy study (Symptom Severity Report (SSR)+Self Care Coaching (SCC) +Nurse Practitioner (NP) +Decision Support System (DSS))
Group 3 NP/DSS/SSR	Nurse Practitioner	Alert reports are generated during the patient's daily symptom severity monitoring call if alert thresholds are reached. Nurse practitioner follow-up calls utilize the evidenced based SCH decision support system (DSS) when symptoms exceed alert thresholds
Group 3 NP/DSS/SSR	Symptom Severity	Alert reports are generated during the patient's daily symptom severity monitoring call if alert thresholds are reached. Nurse practitioner follow-up calls utilize the evidenced based SCH decision support system (DSS) when symptoms exceed alert thresholds
Group 4 Full Intervention SSR/SCC/NP/DSS	Nurse Practitioner	Complete intervention with all components used in prior efficacy study (Symptom Severity Report (SSR)+Self Care Coaching (SCC) +Nurse Practitioner (NP) +Decision Support System (DSS))
Group 4 Full Intervention SSR/SCC/NP/DSS	Symptom Severity	Complete intervention with all components used in prior efficacy study (Symptom Severity Report (SSR)+Self Care Coaching (SCC) +Nurse Practitioner (NP) +Decision Support System (DSS))
Group 5 SSR/SCC/AT	SCC	Symptom severity reporting (SSR), automated self-care coaching (SCC) based on daily symptom reporting plus activity tracker (AT)
Group 5 SSR/SCC/AT	Symptom Severity	Symptom severity reporting (SSR), automated self-care coaching (SCC) based on daily symptom reporting plus activity tracker (AT)

Primary Outcome Measures

Name	Time	Method
Patient reported symptom levels	up to 6 months	During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.

Secondary Outcome Measures

Name	Time	Method
Overall Health functioning: physical, mental, and social	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)
Health Care Utilization & Medical Encounters Interview	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.
Work Limitations Questionnaire	up to 6 months	The 25 item patient-reported Work Limitations Questionnaire will be used to measure work performance.
Work Interference	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.
Baseline Physical Activity	Baseline	We will measure baseline physical activity using the 3 item Godin's Leisure-Time Exercise Questionnaire

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States