Hospice and End-of-life Symptom Monitoring & Support Using an Automated System Designed for Family Caregivers (SCP)

May 15, 2017 updated by: Kathleen Mooney, University of Utah

Enhancing End-of-Life and Bereavement Outcomes Among Cancer Caregivers: Symptom Care by Phone for Hospice Caregiver Support and Cancer Symptom Relief

Improving end-of-life care and the suffering caused by poorly controlled symptoms is an important public health concern. The development of an automated telephone symptom monitoring and support system that assists caregivers in providing end-of-life care and communicating information to the patient's hospice nurse has the potential to enhance the management of common end of life symptoms, thus reducing the suffering of patients at end of life as well as the suffering of their family caregivers. This study has developed such a system and is testing the effectiveness of this system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Individuals dying from cancer often live out their lives at home with a host of poorly controlled symptoms. Ineffective symptom management results, in part, from inadequate monitoring of patients once they leave the treatment-focused arena of the clinical setting. The changing pattern of symptoms is challenging as care strategies and recommendations from previous encounters with healthcare providers become quickly outdated. The burden of end-of-life care largely falls to family caregivers, usually a spouse or partner, who feel enormous pressure to provide physical and supportive care but often lacks the knowledge and skill resulting in significant caregiver burden and distress that may extend into bereavement.

This prospective, clinical trial proposes to develop and test a telecommunication system, Symptom Care by Phone- Hospice that has been designed to bridge the divide between home and palliative care support for patients at the end of life and their family caregiver. SCP-Hospice has three elements: 1) daily monitoring of symptoms common at end of life, 2) automated alerting of the hospice nurse case manager about symptoms that have exceeded a pre-set threshold for symptom severity or caregiver distress about symptoms, and 3) automated, just in time, tailored care management strategies for the caregiver to implement to address the patient's symptoms. Caregivers call the SCP-Hospice system daily to report patient symptoms and then are immediately provided automated, tailored care suggestions paired to the specific symptom profile.

The specific aims of the study are to test whether the SCP-Hospice intervention reduces severity and distress from 12 different symptoms and whether it decreases caregiver burden, anxiety, depressed mood and distress about the patient's symptoms and improves caregiver sleep when compared with usual care. The mechanisms that explain how SCP-Hospice affect these outcomes also will be explored. Other aims will compare patient care strategies utilized by caregivers and evaluate caregiver and Hospice nurse satisfaction with the SCP system.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
365

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah College of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patient/Caregiver Dyad Inclusion Criteria:

  • Both patient and caregiver are adults age 18 or over
  • Patients has a limited life expectancy and has histological diagnosis of cancer
  • Caregiver is caring for a family member with a limited life expectancy and admitted to one of the participating home care hospice or palliative care programs
  • Caregiver is English speaking and writing
  • Caregiver has access to a telephone on a daily basis
  • Caregiver is cognitively and physically able to use the phone unassisted and complete questionnaires.
  • Patient is assigned to a nurse case manager who has consented to participate in the research project
  • Caregiver and patient intend to reside in the local area until the time of the patient's death

Exclusion Criteria:

  • patient not being cared for by a partnering hospice
  • patient without a histological diagnosis of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
SCP-Hospice Alert
Behavioral: SCP-Hospice Alert
The intervention in Project 1 SCP utilizes a multi-faceted system. The SCP-Hospice symptom management model will include several features: 1) a computer-based telecommunication system to monitor symptoms as perceived and reported by the family caregiver; 2) tailored care management messages that SCP provides directly to the caregivers to promote care management based on the individualized patient symptom profile and caregiver distress; and 3) an automated alerting function that notifies the hospice nurse of unrelieved symptoms that have exceeded a pre-set threshold.
No Intervention: Usual Care
Caregiver calls into monitoring system to report the patient's end of life symptoms but does not receive feedback about the symptoms and the hospice nurse does not receive the information.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Family Caregiver's Assessment of Dying Patient's Symptom Severity Level at End-of-Life
Time Frame: Changes in patient's end-of-life symptom levels are reported daily by the family caregiver from baseline (date of consent) until the patient's death or 6 months whichever occurs last.
Caregiver's report their assessment of the severity of patient's symptoms daily.
Changes in patient's end-of-life symptom levels are reported daily by the family caregiver from baseline (date of consent) until the patient's death or 6 months whichever occurs last.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kathleen H Mooney, PhD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 33122-SCP
  • 1P01CA138317 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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