SymptomCare@Home: Deconstructing an Effective Symptom Management Intervention

Cancer Clinical Trial

— SCH  

Official title:

SymptomCare@Home (SCH): Deconstructing an Effective, Technology-assisted, Symptom Management Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779725
• Other study ID #: IRB_00087666
• Secondary ID: R01CA206522
• Status: Completed
• Phase: N/A
• Start date: August 7, 2017
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 884
• Est. completion date: September 30, 2022
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• SCC
Automated self-management coaching paired to symptom reports during daily symptom monitoring call
• 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.
• 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.
• 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.
• Symptom Severity
Automated patient-reporting of 11 common cancer treatment symptoms

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
University of Utah	Emory University, Huntsman Cancer Institute, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient End of Study Telephone Interview	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.	up to 6 months
Primary	Patient reported symptom levels	During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.	up to 6 months
Secondary	Overall Health functioning: physical, mental, and social	This will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 + 2 items from the PROMIS 10 (92-95)	up to 6 months
Secondary	Work Interference	For patients who indicated they worked during their treatment, the system asked daily if they missed work if it was a regular workday.	up to 6 months
Secondary	Work Limitations Questionnaire	The 25 item patient-reported Work Limitations Questionnaire will be used to measure work performance.	up to 6 months
Secondary	Health Care Utilization & Medical Encounters Interview	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.	up to 6 months
Secondary	Baseline Physical Activity	We will measure baseline physical activity using the 3 item Godin's Leisure-Time Exercise Questionnaire	Baseline