NCT02112461

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 17, 2017

Status Verified

February 1, 2017

Enrollment Period

5.8 years

First QC Date

February 28, 2014

Last Update Submit

May 15, 2017

Conditions

DeathCancer

Keywords

end of life care

Outcome Measures

Primary Outcomes (1)

  • Family Caregiver's Assessment of Dying Patient's Symptom Severity Level at End-of-Life

    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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

SCP-Hospice Alert

Behavioral: SCP-Hospice Alert

Usual Care

NO INTERVENTION

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.

Interventions

SCP-Hospice AlertBEHAVIORAL

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah College of Nursing

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • Mooney K, Whisenant MS, Wilson CM, Coombs LA, Lloyd J, Alekhina N, Sloss EA, Steinbach M, Moraitis AM, Berry P, Iacob E, Donaldson G. Technology-Assisted mHealth Caregiver Support to Manage Cancer Patient Symptoms: A Randomized Controlled Trial. J Pain Symptom Manage. 2023 Jul;66(1):33-43. doi: 10.1016/j.jpainsymman.2023.02.320. Epub 2023 Mar 7.

    PMID: 36889453DERIVED

MeSH Terms

Conditions

DeathNeoplasms

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kathleen H Mooney, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2014

First Posted

April 14, 2014

Study Start

May 1, 2010

Primary Completion

March 1, 2016

Study Completion

April 1, 2017

Last Updated

May 17, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)