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OpenTrials
Completed

NCT Number: NCT00799084

Automated Telephone Monitoring for Symptom Management

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Michigan State University

East Lansing, Michigan, 48824, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse

Behavioral

Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management

AVR

Behavioral

Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management

Primary outcomes

  1. Lower reported mean severity index among 7 prevalent symptoms

    Time frame: 9 weeks, 15 weeks

Secondary outcomes

  1. 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.

    Time frame: 9 weeks, 15 weeks

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Registry information

Acronym: ATSM

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Nov 27, 2008
Registry last updated
Dec 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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