Automated Telephone Monitoring for Symptom Management

Carcinoma Clinical Trial

— ATSM  

Official title:

Automated Telephone Monitoring for Symptom Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799084
• Other study ID #: R01CA030724
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2008
• Last updated: December 6, 2011
• Start date: April 2003
• Est. completion date: November 2006

Study information

• Verified date: December 2011
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma

Intervention

Behavioral:
• Nurse
Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
• AVR
Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower reported mean severity index among 7 prevalent symptoms		9 weeks, 15 weeks	No
Secondary	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	No