NCT01973946

Brief Summary

The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
358

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

2 active sites

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

September 1, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

4.6 years

First QC Date

October 22, 2013

Last Update Submit

February 28, 2017

Conditions

Cancer

Keywords

Cancer

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.

    Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.

Secondary Outcomes (5)

  • Medical Encounters Telephone Interview

    Each week patients reported during the daily symptom monitoring call whether they had a medical encounter for an entire new course of chemotherapy or 6 months whichever occurred first.

  • Patient reported symptom related interference with daily activities

    Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.

  • SF-36 Functional Status

    Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.

  • Work interference

    Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.

  • Work Limitations Questionnaire

    Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.

Other Outcomes (2)

  • Patient End of Study Telephone Interview

    Administered once, at the end of the patients' participation in the study which was following an entire new course of chemotherapy or 6 months whichever occurred first.

  • Evaluation of automated and other self care strategies used and their effectiveness

    Weekly for an entire new course of chemotherapy or 6 months whichever occurred first.

Study Arms (2)

Usual Care

NO INTERVENTION

Patients in the usual care group called the automated monitoring system daily to report presence, severity, and distress for 11 common symptoms. The attentional control group received equivalent contact time with the automated system including identical voice and assessment questions. Patients did not hear self-care messages during the call and the data were not available for clinical action by the study nurse practitioner. Patients were told on every phone call to call their oncology providers if they had concerns about their symptoms which is usual care for symptom follow up in oncology.

Symptom Alert and Coaching

EXPERIMENTAL

Patients in the Symptom Alert and Coaching arm called the automated monitoring system daily to report presence, severity, and distress on 11 symptoms. The system provided automated self care coaching based on the symptoms reported and automatically generated alerts to the study NP if symptoms exceeded preset thresholds. Two thresholds were set: a simple alert when severity or distress was 4 or greater on a 10 point scale and trend alerts based on a pattern of moderate severity over several days. The alerts went into a case management site. The study NP logged into the system daily and responded to the alerts within 24 hours by calling patients to further assess the symptoms and to intensify symptom treatment using evidence based guidelines.

Other: Symptom Alert and Coaching

Interventions

Symptom Alert and CoachingOTHER

Patients heard self-care messages when they reported a symptom was present. The Symptom Alert and Coaching intervention alerted study nurse practitioners of unresolved symptoms daily. The NPs responded to all alerts generated by patients and using evidence based guidelines, called patients to further assess and to intensify symptom treatment.

Symptom Alert and Coaching

Eligibility Criteria

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

You may qualify if:

  • Adult (age 18 or over)
  • Have a histological diagnosis of cancer
  • a life expectancy of at least 3 months and cognitively able to participate
  • Beginning a new course of chemotherapy that is planned for a minimum of 3 cycles;
  • care is under the direction of one of the 8 designated provider teams;
  • English speaking;
  • has access to a telephone on a daily basis and is able to use the phone unassisted as verified by the study staff during participant orientation.

You may not qualify if:

  • patients who are receiving concurrent radiation therapy (as they would have daily contact with the health care system);
  • patients who see the provider team for recommendation of a chemotherapy regimen but treatment is then administered at a different site by other providers.
  • Patients receiving therapy agents that result in a drug related fever or therapy agents that are not anticipated to cause any of the 11 symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Related Publications (3)

  • Mooney K, Beck SL, Wilson C, Coombs L, Whisenant M, Moraitis AM, Sloss EA, Alekhina N, Lloyd J, Steinbach M, Nicholson B, Iacob E, Donaldson G. Assessing Patient Perspectives and the Health Equity of a Digital Cancer Symptom Remote Monitoring and Management System. JCO Clin Cancer Inform. 2024 Jul;8:e2300243. doi: 10.1200/CCI.23.00243.

    PMID: 39042843DERIVED

  • Moraitis AM, Iacob E, Wong B, Beck SL, Echeverria C, Donaldson G, Mooney K. Pairing automated exercise coaching with patient-reported symptom monitoring: A way to nudge exercise uptake during cancer treatment? Support Care Cancer. 2024 Apr 1;32(4):258. doi: 10.1007/s00520-024-08450-1.

    PMID: 38558321DERIVED

  • Mooney KH, Beck SL, Wong B, Dunson W, Wujcik D, Whisenant M, Donaldson G. Automated home monitoring and management of patient-reported symptoms during chemotherapy: results of the symptom care at home RCT. Cancer Med. 2017 Mar;6(3):537-546. doi: 10.1002/cam4.1002. Epub 2017 Jan 30.

    PMID: 28135050DERIVED

MeSH Terms

Conditions

Neoplasms

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

October 22, 2013

First Posted

November 1, 2013

Study Start

September 1, 2007

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

March 1, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)