Expired Study
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East Lansing, Michigan 48824


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.


Study summary:

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.


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


NCT ID:

NCT00799084


Primary Contact:

Principal Investigator
Charles Given, PhD
Michigan State University


Backup Contact:

N/A


Location Contact:

East Lansing, Michigan 48824
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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