Automated Telephone Monitoring for Symptom Management

Study Overview
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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.

Official Title
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Automated Telephone Monitoring for Symptom Management

Conditions
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Carcinoma

Intervention / Treatment
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* Behavioral: Nurse
* Behavioral: AVR


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse<br>Receives symptom management assistance from an oncology nurse via the telephone | Behavioral: Nurse<br>* Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management<br>|
| Experimental: AVR<br>Receives symptom management assistance from an Automated telephone system | Behavioral: AVR<br>* Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower reported mean severity index among 7 prevalent symptoms |  | 9 weeks, 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 9 weeks, 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symptom management, cancer, chemotherapy treatment, Behavioral Research, Physiological Effects of Drugs, Clinical Trial, Phase II