SymptomCare@Home: Deconstructing an Effective Symptom Management Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

884 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2022-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group 1 SCC/SSR

This arm includes self-care coaching (SCC) message during daily self-reported symptom severity report (SSR) calls to the automated system.

Group Type ACTIVE_COMPARATOR

SCC

Intervention Type BEHAVIORAL

Automated self-management coaching paired to symptom reports during daily symptom monitoring call

Symptom Severity

Intervention Type BEHAVIORAL

Automated patient-reporting of 11 common cancer treatment symptoms

Group 2 NP/SSR

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 Type ACTIVE_COMPARATOR

Nurse Practitioner

Intervention Type BEHAVIORAL

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.

Symptom Severity

Intervention Type BEHAVIORAL

Automated patient-reporting of 11 common cancer treatment symptoms

Group 3 NP/DSS/SSR

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 Type ACTIVE_COMPARATOR

Nurse Practitioner

Intervention Type BEHAVIORAL

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.

DSS

Intervention Type BEHAVIORAL

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.

Symptom Severity

Intervention Type BEHAVIORAL

Automated patient-reporting of 11 common cancer treatment symptoms

Group 4 Full Intervention SSR/SCC/NP/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 Type ACTIVE_COMPARATOR

SCC

Intervention Type BEHAVIORAL

Automated self-management coaching paired to symptom reports during daily symptom monitoring call

Nurse Practitioner

Intervention Type BEHAVIORAL

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.

DSS

Intervention Type BEHAVIORAL

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.

Symptom Severity

Intervention Type BEHAVIORAL

Automated patient-reporting of 11 common cancer treatment symptoms

Group 5 SSR/SCC/AT

Symptom severity reporting (SSR), automated self-care coaching (SCC) based on daily symptom reporting plus activity tracker (AT)

Group Type ACTIVE_COMPARATOR

SCC

Intervention Type BEHAVIORAL

Automated self-management coaching paired to symptom reports during daily symptom monitoring call

AT

Intervention Type BEHAVIORAL

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.

Symptom Severity

Intervention Type BEHAVIORAL

Automated patient-reporting of 11 common cancer treatment symptoms

Interventions

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SCC

Automated self-management coaching paired to symptom reports during daily symptom monitoring call

Intervention Type BEHAVIORAL

Nurse Practitioner

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.

Intervention Type BEHAVIORAL

DSS

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.

Intervention Type BEHAVIORAL

AT

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.

Intervention Type BEHAVIORAL

Symptom Severity

Automated patient-reporting of 11 common cancer treatment symptoms

Intervention Type BEHAVIORAL

Other Intervention Names

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Self-Management Coaching Nurse Practitioner Follow Up Clinical Decision Support System Activity Tracker Patient Reported Symptom Severity

Eligibility Criteria

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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).