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Automated Telephone Monitoring for Symptom Management

Phase 2
21 Years
Not Enrolling

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Trial Information

Automated Telephone Monitoring for Symptom Management

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Lower reported mean severity index among 7 prevalent symptoms

Outcome Time Frame:

9 weeks, 15 weeks

Safety Issue:


Principal Investigator

Charles Given, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Michigan State University


United States: Institutional Review Board

Study ID:

R01 CA30724



Start Date:

April 2003

Completion Date:

November 2006

Related Keywords:

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



Michigan State UniversityEast Lansing, Michigan  48824