Patients receiving cancer chemotherapy often suffer needlessly at home from poorly controlled treatment-related symptoms that their cancer care provider team are unaware are occurring.
The aim of this randomized clinical trial is to test the efficacy of Telephone-Linked care for Chemotherapy alerting (TLC-Chemo-Alert) in improving symptom management of patients receiving chemotherapy for cancer. A 4x2 factorial design is proposed. TLC-Chemo-Alert is a computer-based telecommunication system, using digitized human voice, that monitors and records the at home symptom experience of cancer patients. Then, by fax, immediately alerts the patient's oncology provider team (medical oncologist and oncology nurse) that the patient is experiencing symptoms that have exceeded a preset threshold for severity. It is hypothesized that TLC-Chemo-Alert will be associated with more frequent provider-initiated contact about poorly controlled symptoms, leading to decreased symptom severity, symptom distress, and less symptom interference with normal activities than an attentional control group. The sample of 240 cancer patients will be to the experimental or attentional control conditions. Subjects will be beginning the second cycle of a new course of chemotherapy. To be eligible, they must have experienced at least one poorly controlled symptom during the first cycle of chemotherapy. The experimental TLC-Chemo-Alert group will receive daily-automated telecommunication symptom monitoring and the TLC provider alerting function, whereas the attentional control will receive the automated telecommunication symptom monitoring for data collection but no provider-alerting feature. The two study groups will be compared over chemotherapy cycles 2 and 3 on provider team-initiated contacts with subjects, the provider team actions taken to improve symptom control, symptom severity, symptom distress, and the degree of symptom interference with normal activities. Characteristics of the provider team contacts and patient and provider satisfaction with the TLC technology will also be assessed. If shown to be effective, TLC-Chemo-Alert will provide an innovation directly applicable to cancer care, a breakthrough in cancer supportive care delivery, and significance improvement in methodological aspects of symptom research.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA089474-02
Application #
6514860
Study Section
Nursing Research Study Section (NURS)
Program Officer
O'Mara, Ann M
Project Start
2001-04-16
Project End
2004-03-31
Budget Start
2002-04-01
Budget End
2003-03-31
Support Year
2
Fiscal Year
2002
Total Cost
$490,501
Indirect Cost
Name
University of Utah
Department
Type
Schools of Nursing
DUNS #
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112
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Brown, Carlton G; Beck, Susan L; Peterson, Douglas E et al. (2009) Patterns of sore mouth in outpatients with cancer receiving chemotherapy. Support Care Cancer 17:413-28
Brown, Carlton G; McGuire, Deborah B; Peterson, Douglas E et al. (2009) The experience of a sore mouth and associated symptoms in patients with cancer receiving outpatient chemotherapy. Cancer Nurs 32:259-70