Clinical trial NCT00799084: Automated Telephone Monitoring for Symptom Management
Official title: Automated Telephone Monitoring for Symptom Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma
Keywords: symptom management
cancer
chemotherapy treatment
Behavioral Research
Physiological Effects of Drugs
Clinical Trial, Phase II
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2008-11-27
Enrollment: 526
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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 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

Primary outcomes:
measure: Lower reported mean severity index among 7 prevalent symptoms
timeFrame: 9 weeks, 15 weeks
Secondary outcomes:
measure: 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.
timeFrame: 9 weeks, 15 weeks
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Charles Given, PhD
role: PRINCIPAL_INVESTIGATOR
References: