SymptomCare@Home: Deconstructing an Effective Symptom Management Intervention
SCH
SymptomCare@Home (SCH): Deconstructing an Effective, Technology-assisted, Symptom Management Intervention
2 other identifiers
interventional
884
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Aug 2017
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2016
CompletedFirst Posted
Study publicly available on registry
May 20, 2016
CompletedStudy Start
First participant enrolled
August 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedNovember 8, 2023
November 1, 2023
2.6 years
May 18, 2016
November 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Overall Health functioning: physical, mental, and social
up to 6 months
Work Interference
up to 6 months
Work Limitations Questionnaire
up to 6 months
Health Care Utilization & Medical Encounters Interview
up to 6 months
Baseline Physical Activity
Baseline
Other Outcomes (1)
Patient End of Study Telephone Interview
up to 6 months
Study Arms (5)
Group 1 SCC/SSR
ACTIVE COMPARATORThis arm includes self-care coaching (SCC) message during daily self-reported symptom severity report (SSR) calls to the automated system.
Group 2 NP/SSR
ACTIVE COMPARATORAlert 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 3 NP/DSS/SSR
ACTIVE COMPARATORAlert 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
ACTIVE COMPARATORComplete 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
ACTIVE COMPARATORSymptom severity reporting (SSR), automated self-care coaching (SCC) based on daily symptom reporting plus activity tracker (AT)
Interventions
Automated self-management coaching paired to symptom reports during daily symptom monitoring call
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.
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.
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.
Automated patient-reporting of 11 common cancer treatment symptoms
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Receiving concurrent radiation therapy
- Exclusively receiving biotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- National Cancer Institute (NCI)collaborator
- Huntsman Cancer Institutecollaborator
- Emory Universitycollaborator
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84112, United States
Related Publications (1)
Mooney K, Gullatte M, Iacob E, Alekhina N, Nicholson B, Sloss EA, Lloyd J, Moraitis AM, Donaldson G. Essential Components of an Electronic Patient-Reported Symptom Monitoring and Management System: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2433153. doi: 10.1001/jamanetworkopen.2024.33153.
PMID: 39269704DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen Mooney, PhD
University of Utah
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor/Principal Investigator
Study Record Dates
First Submitted
May 18, 2016
First Posted
May 20, 2016
Study Start
August 7, 2017
Primary Completion
March 31, 2020
Study Completion
September 30, 2022
Last Updated
November 8, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be available once the primary aims of the R01 study have been published.
- Access Criteria
- Data will be available to address research questions/hypothesis of the request. Once the Principal Investigator reviews the research question proposed, the data elements that can address the question will be shared.
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.