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Automated Telephone Monitoring for Symptom Management

NCT ID: NCT00799084

Last Updated: 2011-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carcinoma

Keywords

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symptom management cancer chemotherapy treatment Behavioral Research Physiological Effects of Drugs Clinical Trial, Phase II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nurse

Receives symptom management assistance from an oncology nurse via the telephone

Group Type EXPERIMENTAL

Nurse

Intervention Type BEHAVIORAL

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

AVR

Receives symptom management assistance from an Automated telephone system

Group Type EXPERIMENTAL

AVR

Intervention Type BEHAVIORAL

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

Interventions

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Nurse

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

Intervention Type BEHAVIORAL

AVR

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Bill Given

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles Given, PhD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

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Michigan State University

East Lansing, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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R01CA030724

Identifier Type: NIH

Identifier Source: org_study_id

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