Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System

NCT01979146 | Completed DMC

• 2 other identifiers: 7846-00R01CA089474
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers.

Conditions

Cancer

Keywords

Cancer

Outcome Measures

Primary Outcomes (1)

• Patient reported symptom levels on a 0-10 scale

  During daily automated calls, patients provided information about common chemotherapy symptoms.

  patients report symptoms daily for the duration of the study, an expected average of 6 weeks

Secondary Outcomes (3)

• Medical Encounters Telephone Interview

  participants will be followed for an expected average of 6 weeks

• Functional Status

  monthly for the duration of the study, participants will be followed for an expected average of 6 weeks

• Work Attendance

  reported daily, participants will be followed for an expected average of 6 weeks

Other Outcomes (2)

• Patient End of Study Telephone Interview

  administered at the end of participation in the study, participants will be followed for an expected average of 6 weeks

• Provider End of Study Interview

  Once, at the end of participation which is an expected average of 24 months

Study Arms (2)

Provider Unrelieved Symptom Alert

EXPERIMENTAL

Patients in the intervention arm called the automated monitoring system daily to report presence, severity and distress on a 1-10 scale for nine symptoms. The system immediately sent an emailed symptom alert report to their oncologist and oncology nurse if symptoms exceeded preset thresholds (moderate to severe levels). Two thresholds were set: a simple alert when severity or distress was 4 or greater on the 10 point scale and trend alerts based on a pattern of moderate severity over several days.

Other: Provider Unrelieved Symptom Alert

Attentional Control Usual Care Group

NO INTERVENTION

Patients in the usual care group called the automated monitoring system daily to report presence, severity and distress (1-10 scale) on 9 symptoms and also measured symptom interference with daily activities, functional status, work attendance, and unscheduled provider visits, urgent care and emergency department visits, and unscheduled hospitalizations. The usual care group received equivalent contact time with the automated system including identical voice and assessment questions. Data were not available for clinical action and not reported to the oncology providers. On every call, usual care participants were reminded to call their oncology provider if they had symptom concerns, which is the usual practice in oncology settings to address unrelieved symptoms.

Interventions

Provider Unrelieved Symptom Alert OTHER

The Provider Unrelieved Symptom Alert intervention sent an automatic symptom report to oncology providers (both physician and nurse) when the patient reported symptoms at a moderate to severe level (4-10 on a 0-10 scale). The oncology providers used their clinical judgement in terms of what they did with the information received. There was no prescribed response as part of the intervention.

Provider Unrelieved Symptom Alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 or older)
• Histological Diagnosis of Cancer
• Life Expectancy of at least 6 months
• Cognitively able to participate (verified by provider team)
• Initiated a course of new Chemotherapy that is planned for a minimum of 3 cycles
• Had Poorly controlled symptoms during the first cycle of chemotherapy
• Care under the direction of one of the designated provider teams
• English or Spanish speaking
• Has access to a telephone on a daily basis
• Able to use the telephone unassisted

You may not qualify if:

• Receiving concurrent radiation therapy because they would be in daily contact with oncology care providers.
• Patients seeing the provider team for recommendation of chemotherapy regimen but other providers then administer treatment at different site
• Patients receiving a treatment regimen with only biotherapy agents or agents not associated with the symptoms monitored

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

South Carolina Community Oncology Practice

Greer, South Carolina, 29650, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

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 8, 2013
• Study Start: April 1, 2001
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)