Automated Telephone Monitoring for Symptom Management

Phase 2

Completed

• Conditions: Carcinoma
• Interventions: Behavioral: Nurse; Behavioral: AVR

• Registration Number: NCT00799084
• Lead Sponsor: Michigan State University

Brief Summary

To improve the management of symptoms, patients with cancer undergoing chemotherapy will be monitored using an automated telephone system to record the severity of 15 prevalent symptoms for up to 8 consecutive weeks. Outcomes include; significant reduction in symptom severity and improvement in health states.

Detailed Description

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.

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-26
• Study First Posted: 2008-11-27
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-06
• Last Update Posted: 2011-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 526

Inclusion Criteria

• 21 years of age or older
• solid tumor cancer diagnosis
• receiving chemotherapy treatment

Exclusion Criteria

• Emotional or psychology disorder for which patient is receiving treatment
• does not speak English
• does not have access to a telephone
• difficulty hearing on the telephone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse	Nurse	Receives symptom management assistance from an oncology nurse via the telephone
AVR	AVR	Receives symptom management assistance from an Automated telephone system

Primary Outcome Measures

Name	Time	Method
Lower reported mean severity index among 7 prevalent symptoms	9 weeks, 15 weeks

Secondary Outcome Measures

Name	Time	Method
Reduced impact of physical role performance, improved social functioning, and reduced emotional distress; improved levels of communication between patients and providers; and improved patient satisfaction with care.	9 weeks, 15 weeks

Trial Locations

Locations (1)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States