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Sponsored by: |
Michigan State University |
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Information provided by: | Michigan State University |
ClinicalTrials.gov Identifier: | NCT00799084 |
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 |
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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 |
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 |
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Nurse: Experimental
Receives symptom management assistance from an oncology nurse via the telephone
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Behavioral: Nurse
Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
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AVR: Experimental
Receives symptom management assistance from an Automated telephone system
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Behavioral: AVR
Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Michigan State University | |
East Lansing, Michigan, United States, 48824 |
Principal Investigator: | Charles Given, PhD | Michigan State University |
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 |
symptom management cancer chemotherapy treatment |
Behavioral Research Physiological Effects of Drugs Clinical Trial, Phase II |
Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Physiological Effects of Drugs |
Pharmacologic Actions Neoplasms, Glandular and Epithelial Carcinoma |