NCT00799084

Automated Telephone Monitoring for Symptom Management

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 526 (actual)
• Sponsor: Michigan State University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Nurse	Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
BEHAVIORAL	AVR	Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management

Timeline

• Start date: 2003-04-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2008-11-27
• Last updated: 2011-12-07

Locations

1 site across 1 country: United States