AzTrials
AzTrials

CancerSCHNCT02779725

SymptomCare@Home: Deconstructing an Effective Symptom Management Intervention

A study testing SCC, Nurse Practitioner and DSS in people with Cancer, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
SCC, Nurse Practitioner and DSS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
884 participants
Where
1 siteUnited States
Study dates
7 Aug 2017to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Receiving concurrent radiation therapy
  • Exclusively receiving biotherapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Cancer
Being tested
SCC, Nurse Practitioner, DSS, AT, Symptom Severity
Keywords
Symptom Management
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCCBehavioural

    Also called Self-Management Coaching

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

  • Nurse PractitionerBehavioural

    Also called Nurse Practitioner Follow Up

    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.

  • DSSBehavioural

    Also called Clinical Decision Support System

    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.

  • ATBehavioural

    Also called Activity Tracker

    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 SeverityBehavioural

    Also called Patient Reported Symptom Severity

    Automated patient-reporting of 11 common cancer treatment symptoms

Study groups in NCT02779725
Study groupRoleWhat they receive
Group 1 SCC/SSRActive comparatorThis arm includes self-care coaching (SCC) message during daily self-reported symptom severity report (SSR) calls to the automated system.
Receives: Behavioral: SCC; Behavioral: Symptom Severity
Group 2 NP/SSRActive 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.
Receives: Behavioral: Nurse Practitioner; Behavioral: Symptom Severity
Group 3 NP/DSS/SSRActive 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
Receives: Behavioral: Nurse Practitioner; Behavioral: DSS; Behavioral: Symptom Severity
Group 4 Full Intervention SSR/SCC/NP/DSSActive 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))
Receives: Behavioral: SCC; Behavioral: Nurse Practitioner; Behavioral: DSS; Behavioral: Symptom Severity
Group 5 SSR/SCC/ATActive comparatorSymptom severity reporting (SSR), automated self-care coaching (SCC) based on daily symptom reporting plus activity tracker (AT)
Receives: Behavioral: SCC; Behavioral: AT; Behavioral: Symptom Severity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient reported symptom levels

    During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.

    Measured: up to 6 months

Secondary outcomes (5)

  1. 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)

    Measured: up to 6 months

  2. 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.

    Measured: up to 6 months

  3. Work Limitations Questionnaire

    The 25 item patient-reported Work Limitations Questionnaire will be used to measure work performance.

    Measured: up to 6 months

  4. 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.

    Measured: up to 6 months

  5. Baseline Physical Activity

    We will measure baseline physical activity using the 3 item Godin's Leisure-Time Exercise Questionnaire

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2016 (estimated)
  2. Study start7 Aug 2017
  3. Primary completion31 Mar 2020
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
884 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02779725
Sponsor's protocol ID
IRB_00087666
Other IDs
R01CA206522
Acronym
SCH
Status last verified
Nov 2023
First submitted
18 May 2016
Last updated
8 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39269704

Questions about this trial

What is this clinical trial studying?

A study testing SCC, Nurse Practitioner and DSS in people with Cancer, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient reported symptom levels (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02779725, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.

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