Clinical trial NCT02779725: SymptomCare@Home: Deconstructing an Effective Symptom Management Intervention
Official title: SymptomCare@Home (SCH): Deconstructing an Effective, Technology-assisted, Symptom Management Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Symptom Management
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Huntsman Cancer Institute
name: Emory University
First posted: 2016-05-20
Enrollment: 884
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Exclusion Criteria:

* Receiving concurrent radiation therapy
* Exclusively receiving biotherapy

Primary outcomes:
measure: Patient reported symptom levels
timeFrame: up to 6 months
Secondary outcomes:
measure: Overall Health functioning: physical, mental, and social
timeFrame: up to 6 months
measure: Work Interference
timeFrame: up to 6 months
measure: Work Limitations Questionnaire
timeFrame: up to 6 months
measure: Health Care Utilization & Medical Encounters Interview
timeFrame: up to 6 months
measure: Baseline Physical Activity
timeFrame: Baseline
Other outcomes:
measure: Patient End of Study Telephone Interview
timeFrame: up to 6 months
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Kathleen Mooney, PhD
role: PRINCIPAL_INVESTIGATOR
References: