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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00423436
First received: January 16, 2007
Last updated: November 14, 2011
Last verified: November 2011
History of Changes
Results First Received: September 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Lung Cancer
Interventions: Behavioral: Questionnaire
Behavioral: Interactive Voice Response Telephone System
Behavioral: IVR Plus Triage

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
IVR Assessment Plus Triage Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
IVR Assessment Only IVR (Phone calls twice weekly) + Questionnaire
Total Total of all reporting groups

Baseline Measures
    IVR Assessment Plus Triage     IVR Assessment Only     Total  
Number of Participants  
[units: participants]
 		  35     33     68  
Age  
[units: years]
Mean ± Standard Deviation 		  64.41  ± 9.11     60.63  ± 8.40     62.5762  ± 8.9158  
Gender  
[units: participants]
 		     
Female     18     18     36  
Male     17     15     32  
Region of Enrollment  
[units: participants]
 		     
United States     35     33     68  



  Outcome Measures

1.  Primary:   Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments   [ Time Frame: Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Charles S Cleeland, PhD, Professor
Organization: UT MD Anderson Cancer Center
e-mail: asaleeba@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00423436     History of Changes
Other Study ID Numbers: ID01-243
Study First Received: January 16, 2007
Results First Received: September 8, 2011
Last Updated: November 14, 2011
Health Authority: United States: Institutional Review Board