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Primary Objectives:
You will be asked to complete several questionnaires during a visit to the Thoracic Clinic. These questionnaires measure physical and emotional symptoms, and quality of life. Completing the questionnaires takes about 30-45 minutes. The research nurse will also teach you how to use the telephone system for reporting symptoms. You will tell the research nurse when the most convenient times for the telephone calls and the telephone system will be set up to call at those times.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| IVR Assessment Only | Experimental | IVR (Phone calls twice weekly) + Questionnaire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | Questionnaires taking about 30-45 minutes to complete. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Cleeland, PhD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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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).
Recruitment Period: 04/30/03 to 12/10/08. All participants recruited at UT MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | IVR Assessment Only | IVR (Phone calls twice weekly) + Questionnaire |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | IVR Assessment Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | Ratio of alerts/number of assessments | Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks) | Alerts | Participants |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles S Cleeland, PhD, Professor | UT MD Anderson Cancer Center | asaleeba@mdanderson.org |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D014218 | Triage |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Interactive Voice Response Telephone System | Behavioral | IVR Only = Phone calls twice weekly, each call lasting less than 5 minutes. |
|
| 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. |
|
|
IVR (Phone calls twice weekly) + Questionnaire |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| 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 |
| OG001 | IVR Assessment Only | IVR (Phone calls twice weekly) + Questionnaire |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | IVR Assessment Only | IVR (Phone calls twice weekly) + Questionnaire | 0 | 33 | 0 | 33 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D004632 | Emergency Medical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |