Lung CancerNCT00423436
Interactive Voice Response (IVR) Symptom Assessment in Non-Small Cell Lung Cancer (NSCLC) Patients
A study testing Questionnaire, Interactive Voice Response Telephone System and IVR Plus Triage in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Questionnaire, Interactive Voice Response Telephone System and IVR Plus Triage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
- 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
Who cannot join
- Current diagnosis of psychosis or dementia
- Patients unable to complete the assessment measures or unable to understand the purpose of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using an Interactive Voice Response Telephone System in the Assessment and Management of Symptoms in Advanced Lung Cancer Patients Receiving Chemotherapy
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.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Being tested
- Questionnaire, Interactive Voice Response Telephone System, IVR Plus Triage
- Keywords
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Voice Response System, Questionnaire, Survey, NSCLC
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires taking about 30-45 minutes to complete.
Interactive Voice Response Telephone SystemBehavioural
IVR Only = Phone calls twice weekly, each call lasting less than 5 minutes.
IVR Plus TriageBehavioural
Also called interactive voice recognition, IVR
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Questionnaire; Behavioral: Interactive Voice Response Telephone System; Behavioral: IVR Plus Triage |
| IVR Assessment Only | Experimental | IVR (Phone calls twice weekly) + Questionnaire Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startApr 2003
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Cleeland, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423436
- Sponsor's protocol ID
- ID01-243
- Status last verified
- Nov 2011
- First submitted
- 16 Jan 2007
- Last updated
- 16 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an Interactive Voice Response Telephone System in the Assessment and Management of Symptoms in Advanced Lung Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT00423436
- Acronym / sponsor ID
- ID01-243
- Conditions
- Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Voice Response System, Questionnaire, Survey, NSCLC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Posted 16 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVR Assessment Plus Triage | Experimental | Behavioral: Questionnaire, Behavioral: Interactive Voice Response Telephone System, Behavioral: IVR Plus TriageInteractive 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 | Behavioral: QuestionnaireIVR (Phone calls twice weekly) + Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.)
- 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
Key exclusion criteria (2 listed)
- Current diagnosis of psychosis or dementia
- Patients unable to complete the assessment measures or unable to understand the purpose of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaires taking about 30-45 minutes to complete. | Behavioural | IVR Assessment Only, IVR Assessment Plus Triage |
| Interactive Voice Response Telephone SystemIVR Only = Phone calls twice weekly, each call lasting less than 5 minutes. | Behavioural | IVR Assessment Plus Triage |
| IVR Plus TriageAlso: interactive voice recognition, IVRIVR 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. | Behavioural | IVR Assessment Plus Triage |
Primary outcome
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)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Cleeland, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire, Interactive Voice Response Telephone System and IVR Plus Triage in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2011.