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Automated Telephone Monitoring for Symptom Management (ATSM)
This study has been completed.
First Received: November 25, 2008   Last Updated: November 26, 2008   History of Changes
Sponsored by: Michigan State University
Information provided by: Michigan State University
ClinicalTrials.gov Identifier: NCT00799084
  Purpose

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.


Condition Intervention Phase
Carcinoma
Behavioral: Nurse
Behavioral: AVR
Phase II

Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Automated Telephone Monitoring for Symptom Management

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Lower reported mean severity index among 7 prevalent symptoms [ Time Frame: 9 weeks, 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 526
Study Start Date: April 2003
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nurse: Experimental
Receives symptom management assistance from an oncology nurse via the telephone
Behavioral: Nurse
Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
AVR: Experimental
Receives symptom management assistance from an Automated telephone system
Behavioral: AVR
Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799084

Locations
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Sponsors and Collaborators
Michigan State University
Investigators
Principal Investigator: Charles Given, PhD Michigan State University
  More Information

No publications provided

Responsible Party: Michigan State University, College of Human Medicine, Dept of Family Medicine ( Charles W. Given )
Study ID Numbers: R01 CA30724
Study First Received: November 25, 2008
Last Updated: November 26, 2008
ClinicalTrials.gov Identifier: NCT00799084     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
symptom management
cancer
chemotherapy treatment
Behavioral Research
Physiological Effects of Drugs
Clinical Trial, Phase II

Study placed in the following topic categories:
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 10, 2009