Lung CancerNCT00501319
Measurement of Pain and Other Symptoms of Non-Small Cell Lung Cancer (NSCLC) Patients Following Thoracic Surgery
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: To longitudinally assess the natural history of symptoms (prevalence, severity, patterns of symptoms, and the relationship of physical and psychological distress) among post-thoracic surgery for non-small cell lung cancer patients with early stage (stage I-IIIA) disease. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Interactive Voice Response (IVR) and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Non-Small Cell Lung Cancer.
Who may be able to join
- Patients scheduled for thoracic surgery for NSCLC (stage I-IIIA)
- Patients >/= 16 years of age
- Patients who speak English
- Patients residing in the United States
Who cannot join
- Current diagnosis of psychosis or dementia
- Patients who have difficulty understanding the intent of the study
- Patients who can not complete the assessment tools
- Patients without telephone access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Measurement of Pain and Other Symptoms of Non-Small Cell Lung Cancer (NSCLC) Patients Following Thoracic Surgery
Primary Objectives:
- To longitudinally assess the natural history of symptoms (prevalence, severity, patterns of symptoms, and the relationship of physical and psychological distress) among post-thoracic surgery for non-small cell lung cancer patients with early stage (stage I-IIIA) disease.
- To determine crisis events (when symptoms are most severe), their relationship with cancer therapy, surgical techniques and disease, and their relationship with function and quality of life; and to determine current practice patterns of symptom control throughout the six months of the post-surgical phase.
- To determine the utility of a weekly, telephone-administered interactive voice response symptom assessment (IVR-MDASI) for identifying emergent clinically significant symptoms in this population.
- To develop symptom severity critical values and critical treatment algorithms for post-operative symptom control for NSCLC patients.
Read the detailed description
Before surgery, you will be asked to complete four surveys about your mood, symptoms, quality of life, and smoking history. Completing the questionnaires will take about 20 minutes. You will be asked for some information about age, sex, race, education, marital status, and employment status (full-time, part-time, unemployed). Before surgery, the research nurse will teach you how to use the special telephone system, called an Interactive Voice Response (IVR) telephone system. This system is used for tracking symptoms at home. An instruction pamphlet will also be given to you.
Three days after surgery, while you are in the hospital, you will be asked by the research nurse to again complete one questionnaires that measures your symptoms.
Once you are home from the hospital, the automatic telephone IVR system will call at a prescheduled time that is convenient for you. The phone call will take about four minutes to complete. The IVR will call once a week for the first 3 months after surgery, and then every two weeks for an additional 3 months.
The research nurse will call you one week after surgery and then one month, three months, and six months to complete four questionnaires about symptoms, mood, quality of life, and smoking history. It will take about 20 minutes to complete the questionnaires.
The information collected by the IVR is for research purposes only, and you must report any symptoms that you are concerned about to your physicians or nurses.
Should severe symptoms develop, research staff will notify the your treatment team.
This is an investigational study. About 112 patients will participate in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lung Cancer
- Being tested
- Interactive Voice Response (IVR), Questionnaire
- Keywords
- Interactive Voice Response Telephone System, Non-Small Cell Lung Cancer, Lung Cancer, Questionnaire, Survey, NSCLC, IVR
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Voice Response (IVR)Behavioural
Phone calls once weekly for the first 3 months after surgery, then every two weeks for an additional 3 months.
QuestionnaireBehavioural
Also called Survey
Questionnaires taking 20 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with Non-Small Cell Lung Cancer. Receives: Behavioral: Interactive Voice Response (IVR); Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the symptoms of patients who receive thoracic surgery for the treatment of lung cancer.
Measured: 6 Years
Secondary outcomes (1)
To test the usefulness of a special telephone system for tracking the symptoms of patients after they have had thoracic surgery.
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startApr 2003
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Xin Shelley Wang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501319
- Sponsor's protocol ID
- ID02-320
- Status last verified
- Nov 2011
- First submitted
- 12 Jul 2007
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Measurement of Pain and Other Symptoms of Non-Small Cell Lung Cancer (NSCLC) Patients Following Thoracic Surgery
- ClinicalTrials.gov ID
- NCT00501319
- Acronym / sponsor ID
- ID02-320
- Conditions
- Lung Cancer
- Keywords
- Interactive Voice Response Telephone System, Non-Small Cell Lung Cancer, Lung Cancer, Questionnaire, Survey, NSCLC, IVR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Apr 2003
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
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 longitudinally assess the natural history of symptoms (prevalence, severity, patterns of symptoms, and the relationship of physical and psychological distress) among post-thoracic surgery for non-small cell lung cancer patients with early stage (stage I-IIIA) disease.
- To determine crisis events (when symptoms are most severe), their relationship with cancer therapy, surgical techniques and disease, and their relationship with function and quality of life; and to determine current practice patterns of symptom control throughout the six months of the post-surgical phase.
- To determine the utility of a weekly, telephone-administered interactive voice response symptom assessment (IVR-MDASI) for identifying emergent clinically significant symptoms in this population.
- To develop symptom severity critical values and critical treatment algorithms for post-operative symptom control for NSCLC patients.
Detailed description
Before surgery, you will be asked to complete four surveys about your mood, symptoms, quality of life, and smoking history. Completing the questionnaires will take about 20 minutes. You will be asked for some information about age, sex, race, education, marital status, and employment status (full-time, part-time, unemployed). Before surgery, the research nurse will teach you how to use the special telephone system, called an Interactive Voice Response (IVR) telephone system. This system is used for tracking symptoms at home. An instruction pamphlet will also be given to you.
Three days after surgery, while you are in the hospital, you will be asked by the research nurse to again complete one questionnaires that measures your symptoms.
Once you are home from the hospital, the automatic telephone IVR system will call at a prescheduled time that is convenient for you. The phone call will take about four minutes to complete. The IVR will call once a week for the first 3 months after surgery, and then every two weeks for an additional 3 months.
The research nurse will call you one week after surgery and then one month, three months, and six months to complete four questionnaires about symptoms, mood, quality of life, and smoking history. It will take about 20 minutes to complete the questionnaires.
The information collected by the IVR is for research purposes only, and you must report any symptoms that you are concerned about to your physicians or nurses.
Should severe symptoms develop, research staff will notify the your treatment team.
This is an investigational study. About 112 patients will participate in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Interactive Voice Response (IVR), Behavioral: QuestionnairePatients with Non-Small Cell Lung Cancer. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Non-Small Cell Lung Cancer.
Key inclusion criteria (4 listed)
- Patients scheduled for thoracic surgery for NSCLC (stage I-IIIA)
- Patients >/= 16 years of age
- Patients who speak English
- Patients residing in the United States
Key exclusion criteria (4 listed)
- Current diagnosis of psychosis or dementia
- Patients who have difficulty understanding the intent of the study
- Patients who can not complete the assessment tools
- Patients without telephone access
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 |
|---|---|---|
| Interactive Voice Response (IVR)Phone calls once weekly for the first 3 months after surgery, then every two weeks for an additional 3 months. | Behavioural | 1 |
| QuestionnaireAlso: SurveyQuestionnaires taking 20 minutes to complete. | Behavioural | 1 |
Primary outcome
To study the symptoms of patients who receive thoracic surgery for the treatment of lung cancer.
Time frame: 6 Years
1 secondary outcome
To test the usefulness of a special telephone system for tracking the symptoms of patients after they have had thoracic surgery.
Time frame: 6 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
- 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.
Xin Shelley Wang, MD 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?
An observational study of 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 4 inclusion and 4 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 8 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To study the symptoms of patients who receive thoracic surgery for the treatment of lung cancer. (time frame: 6 Years). 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 8 Nov 2011.