Interactive Voice Response (IVR) Symptom Assessment in Non-Small Cell Lung Cancer (NSCLC) Patients

NCT00423436 | Completed Results

• 1 other identifier: ID01-243
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

• To compare the effectiveness of an interactive voice response (IVR) telephone triage/feedback system versus an interactive voice response telephone system with assessment only in monitoring and managing symptoms in patients with advanced non small cell lung cancer (NSCLC).
• To compare differences in mood and quality of life variables of patients using the IVR triage/feedback system versus IVR assessment only.
• To compare the healthcare utilization (emergency visits, admissions, length of stay for hospitalizations for uncontrolled symptoms) of patients using the IVR triage/feedback system versus IVR assessment only.

Conditions

Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Small Cell Lung Cancer; Voice Response System; Questionnaire; Survey; NSCLC

Outcome Measures

Primary Outcomes (1)

• Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments

  Total number of alerts generated by symptom exceeding prespecified threshold for 7 symptoms - pain, fatigue, nausea, cough, constipation, vomiting and shortness of breath (Ratio alerts/number of assessments using IVR telephone triage/feedback versus IVR only). Reporting 0-10 severity scale of MD Anderson Symptom Inventory from 0 (symptom not present) to 10 (symptom bad as imagine it could be). Thresholds set at 4 on scale for all symptoms except shortness of breath and constipation where threshold set at 2. More than one symptom alert may appear per assessment causing ratio values to exceed 1.

  Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks)

Study Arms (2)

IVR Assessment Plus Triage

EXPERIMENTAL

Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire

Behavioral: Questionnaire; Behavioral: Interactive Voice Response Telephone System; Behavioral: IVR Plus Triage

IVR Assessment Only

EXPERIMENTAL

IVR (Phone calls twice weekly) + Questionnaire

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaires taking about 30-45 minutes to complete.

Also known as: Survey

IVR Assessment Only; IVR Assessment Plus Triage

Interactive Voice Response Telephone System BEHAVIORAL

IVR Only = Phone calls twice weekly, each call lasting less than 5 minutes.

IVR Assessment Plus Triage

IVR Plus Triage BEHAVIORAL

IVR system will "triage," or sort, the symptom data by symptom severity, notifying health care professionals when a symptom is greater than the set threshold limit.

Also known as: interactive voice recognition, IVR

IVR Assessment Plus Triage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with stage III or IV non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) (Patients who have received other prior chemotherapy are eligible.)
• years of age or older
• English-speaking
• Lives in the United States
• Adequate vision and hearing to use the Interactive Voice Response (IVR) system
• Provides written informed consent

You may not qualify if:

• Current diagnosis of psychosis or dementia
• Patients unable to complete the assessment measures or unable to understand the purpose of the study

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Surveys and Questionnaires; Triage

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Emergency Medical Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Charles S Cleeland, PhD, Professor
• Organization: UT MD Anderson Cancer Center

asaleeba@mdanderson.org

Study Officials

• Charles Cleeland, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: April 1, 2003
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 16, 2011
• Results First Posted: December 16, 2011

Record last verified: 2011-11

Locations

US (1)