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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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 04/30/03 to 12/10/08. All participants recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 84 enrolled, 16 participants dropped out before baseline assessment, prior to group assignment. Baseline data analysis was done on the remaining 68 patients (35 in the intervention and 33 in the control group).

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

Participant Flow: Overall Study

	IVR Assessment Plus Triage	IVR Assessment Only
STARTED	35	33
COMPLETED	35	33
NOT COMPLETED	0	0

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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Measure Type	Primary
Measure Title	Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments
Measure Description	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.
Time Frame	Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was per protocol. Due to attrition, data from 61 participants were analyzed at end of first chemotherapy cycle and from 27 participants at the end of the study.

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

Measured Values

	IVR Assessment Plus Triage	IVR Assessment Only
Number of Participants Analyzed [units: participants]	35	33
Number of Alerts Analyzed [units: Alerts]	100	200
Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments [units: Ratio of alerts/number of assessments]	0.96	1.56

No statistical analysis provided for Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments

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

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