Interactive Voice Response (IVR) Symptom Assessment in Non-Small Cell Lung Cancer (NSCLC) Patients
NCT ID: NCT00423436
Last Updated: 2011-12-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
84 participants
INTERVENTIONAL
2003-04-30
2011-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
It is not clear at this time whether the telephone symptom evaluation is better than the usual plan that doctors and nurses follow for asking about symptoms. For this reason, you will be randomly picked (as in the toss of a coin) to be in one of two groups. The chance of being in either one of the two programs is about equal.
Half of the patients will be assigned to the "telephone assessment system plus triage" group. If you are assigned to this group, you will report symptoms to the telephone system and the doctor or nurse at M.D. Anderson will be notified when a symptom is severe. You will also be encouraged to report all symptoms to their doctor and nurse at M.D. Anderson.
Half of the patients will be assigned to the "telephone assessment only" group. If you are assigned to this group, your symptom information will only be given through the telephone system. You will also be encouraged to report all symptoms directly to your doctor and nurse at M.D. Anderson. Your physician may request information from the telephone system.
If you are assigned to this "telephone assessment only" group, the telephone system will call you twice a week during 2 cycles of chemotherapy. It is programmed to ask you to rate your symptoms and how much the symptoms interfere in your life. Rating symptoms using the telephone system takes less than five minutes for each call.
After each chemotherapy cycle, you and patients in both groups will be asked to fill out questionnaires during a clinic visit. The questionnaires are used to measure emotional symptoms and quality of life. Completing the questionnaires takes about 15-30 minutes. Your medical charts will also be reviewed and information collected about medical history.
If you have agreed to participate in the companion caregiver study, the study staff will use your demographic and clinical data to study the influence of your symptoms on your caregiver's physical and mental health.
This is an investigational study. About 100 will be enrolled at M.D. Anderson Cancer Center. A total of 136 patients will take part in this multicenter study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Questionnaire
Questionnaires taking about 30-45 minutes to complete.
Interactive Voice Response Telephone System
IVR Only = Phone calls twice weekly, each call lasting less than 5 minutes.
IVR Plus Triage
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.
IVR Assessment Only
IVR (Phone calls twice weekly) + Questionnaire
Questionnaire
Questionnaires taking about 30-45 minutes to complete.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Questionnaire
Questionnaires taking about 30-45 minutes to complete.
Interactive Voice Response Telephone System
IVR Only = Phone calls twice weekly, each call lasting less than 5 minutes.
IVR Plus Triage
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 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
Exclusion Criteria
* Patients unable to complete the assessment measures or unable to understand the purpose of the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charles Cleeland, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
MD Anderson Cancer Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ID01-243
Identifier Type: -
Identifier Source: org_study_id