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SymptomCare@Home: Deconstructing an Effective Symptom Management Intervention (SCH)

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ClinicalTrials.gov Identifier: NCT02779725
Recruitment Status : Enrolling by invitation
First Posted : May 20, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Huntsman Cancer Institute
Emory University
Information provided by (Responsible Party):
Kathleen Mooney, 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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: SCC Behavioral: Nurse Practitioner Behavioral: DSS Behavioral: AT Behavioral: Symptom Severity Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: SymptomCare@Home (SCH): Deconstructing an Effective, Technology-assisted, Symptom Management Intervention
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: SCC
Automated self-management coaching paired to symptom reports during daily symptom monitoring call
Other Name: Self-Management Coaching

Behavioral: Symptom Severity
Automated patient-reporting of 11 common cancer treatment symptoms
Other Name: Patient Reported Symptom Severity

Active Comparator: 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.
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.
Other Name: Nurse Practitioner Follow Up

Behavioral: Symptom Severity
Automated patient-reporting of 11 common cancer treatment symptoms
Other Name: Patient Reported Symptom Severity

Active Comparator: 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
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.
Other Name: Nurse Practitioner Follow Up

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.
Other Name: Clinical Decision Support System

Behavioral: Symptom Severity
Automated patient-reporting of 11 common cancer treatment symptoms
Other Name: Patient Reported Symptom Severity

Active Comparator: 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))
Behavioral: SCC
Automated self-management coaching paired to symptom reports during daily symptom monitoring call
Other Name: Self-Management Coaching

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.
Other Name: Nurse Practitioner Follow Up

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.
Other Name: Clinical Decision Support System

Behavioral: Symptom Severity
Automated patient-reporting of 11 common cancer treatment symptoms
Other Name: Patient Reported Symptom Severity

Active Comparator: Group 5 SSR/SCC/AT
Symptom severity reporting (SSR), automated self-care coaching (SCC) based on daily symptom reporting plus activity tracker (AT)
Behavioral: SCC
Automated self-management coaching paired to symptom reports during daily symptom monitoring call
Other Name: Self-Management Coaching

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.
Other Name: Activity Tracker

Behavioral: Symptom Severity
Automated patient-reporting of 11 common cancer treatment symptoms
Other Name: Patient Reported Symptom Severity




Primary Outcome Measures :
  1. Patient reported symptom levels [ Time Frame: up to 6 months ]
    During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.


Secondary Outcome Measures :
  1. Overall Health functioning: physical, mental, and social [ 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)

  2. Work Interference [ 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.

  3. Work Limitations Questionnaire [ Time Frame: up to 6 months ]
    The 25 item patient-reported Work Limitations Questionnaire will be used to measure work performance.

  4. Health Care Utilization & Medical Encounters Interview [ 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.

  5. Baseline Physical Activity [ Time Frame: Baseline ]
    We will measure baseline physical activity using the 3 item Godin's Leisure-Time Exercise Questionnaire


Other Outcome Measures:
  1. Patient End of Study Telephone Interview [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779725


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
National Cancer Institute (NCI)
Huntsman Cancer Institute
Emory University
Investigators
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Principal Investigator: Kathleen Mooney, PhD University of Utah

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Responsible Party: Kathleen Mooney, Distinguished Professor/Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT02779725     History of Changes
Other Study ID Numbers: IRB_00087666
R01CA206522 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will present our findings at conferences and publish the findings. We welcome analysis and use by other investigators once our primary aims have been analyzed and disseminated. The PI will share de-identified data to other investigators for study, including demographics, diagnosis, chemotherapy treatment, symptom patterns, work attendance, overall health function and health care utilization. Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes. The PI agrees to make available data within one year of the completion of the funded project period and manuscripts pertaining to the aims. De-identified data will be available directly from the PI. The PI agrees to share data in a manner that is fully consistent with NIH data sharing policies and applicable laws and regulations.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathleen Mooney, University of Utah:
Symptom Management