Automated Telephone Monitoring for Symptom Management
Overview: Prevalent symptoms among patients undergoing chemotherapy include: pain, fatigue,
dry mouth, constipation, anorexia, nausea, sleep disturbance, shortness of breath or
difficulty breathing, as well as psychological symptoms such as depression and anxiety. A
survey of 1000 patients with cancer indicated that close to a quarter reported 10-12
symptoms. Given the impact of symptoms upon physical function, work, emotional distress,
and hospitalizations, it is critical that strategies be developed and tested to improve
symptom management.
This trial of a behavioural intervention for symptom management is significant because: 1)
it contrasts a proactive approach, individualized to patients' symptom management needs,
with a more conventional model that places responsibility on the patient for symptom
management; 2) it controls for the method of delivery and the use of printed material; 3) it
targets prevalent symptoms known to affect cancer patients undergoing chemotherapy; 4) it
examines the relative effects of each arm, in terms of symptom severity (primary outcome),
impact on patients' physical and social roles, and emotional distress; and 5) it explores
these outcomes in terms of their impact on the use of services and costs of care.
Goal: The goal of this randomized trial is to determine if a nurse delivered Patient
Assisted Management of Symptoms (PAMS) intervention individualized to patients' needs for
symptom management, delivered by telephone, when compared to Telephone Information and
Monitoring of Symptoms (TIMS) where symptoms are only monitored by telephone, with
references to the symptom management toolkit will reduce symptom severity, improve physical
function, and other outcomes.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Lower reported mean severity index among 7 prevalent symptoms
9 weeks, 15 weeks
No
Charles Given, PhD
Principal Investigator
Michigan State University
United States: Institutional Review Board
R01 CA30724
NCT00799084
April 2003
November 2006
Name | Location |
---|---|
Michigan State University | East Lansing, Michigan 48824 |