Breast CancerNCT00881010
Automated Pain Intervention for Underserved Minority Breast Cancer Patients
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this psychosocial research study is to learn about treating pain and other symptoms of minority patients who have breast cancer. The study will test how well a special telephone system works for improving the pain and symptom management of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Telephone Intervention and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to 12 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Disadvantaged African American or Hispanic females diagnosed with breast cancer aged 18 years or older with access to telephones.
Who may be able to join
- Diagnosis of breast cancer
- African American or Hispanic female
- Receiving treatment at LBJ General Hospital, Ben Taub Hospital, or M.D. Anderson Cancer Center
- Socioeconomically disadvantaged, as indicated by hospital billing code
- 18 years of age or older
- Living in the United States
- Speaks English or Spanish
- "Pain worst" score of 4 or greater on the Brief Pain Inventory
Who cannot join
- Current diagnosis of psychosis or dementia
- No access to telephones
- Unable to use the IVR system due to physical limitations (e.g., hearing impairment)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this psychosocial research study is to learn about treating pain and other symptoms of minority patients who have breast cancer. The study will test how well a special telephone system works for improving the pain and symptom management of these patients.
Read the detailed description
The special telephone system used in this study calls patients on a regular basis and asks them to report their symptoms. The patient's doctor or nurse is notified by a page or e-mail when one or more of these symptoms is severe: pain, shortness of breath, nausea, vomiting, drowsiness, sadness, and emotional distress. Researchers want to find out if using the telephone system is a better way to manage a patient's pain and symptoms than the normal method, in which the doctor and nurse would simply ask about pain and other symptoms.
You will be asked to complete several questionnaires during a visit to the oncology clinic. These questionnaires measure pain and other symptoms, quality of life, and mood. Completing the questionnaires takes about 1 hour. These will be completed during your first study visit (called the "baseline" visit.)
If you choose to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive 1 of 2 treatment plans: telephone intervention or usual care. You have an equal chance of being assigned to either group.
If you are picked to be in the "telephone intervention" group, the research nurse will teach you how to use the telephone system for measuring symptoms. The research nurse also will ask you to practice using the telephone system. The telephone system will call you 2 times a week for 10 weeks and ask you to rate your pain and other symptoms and how much the symptoms interfere with your life. You can set up the most convenient times for the telephone calls. Rating your symptoms using the telephone system takes less than 5 minutes for each call.
Your symptom information from the telephone system will be given to your doctor and nurse at M. D. Anderson. The doctor or nurse will be notified right away by page or e-mail when one or more of these symptoms is severe: pain, shortness of breath, nausea, vomiting, drowsiness, sadness, and emotional distress. Patients in this group will also receive education from the telephone system about pain and pain treatments. If for some reason the telephone system is not working, the research staff will report your severe symptoms to your doctor of nurse, and give you the education about pain and pain treatments.
If you are assigned to the "usual care" group, then you will not be asked to report symptoms using the telephone system, and your symptom information from the questionnaires will not be given to your doctor and nurse at M. D. Anderson.
No matter what group you are assigned to, you will be asked to report all symptoms to your doctor and nurse during your visits to the oncology clinic. You will also be asked to call your doctor or nurse when symptoms are severe. The doctors and nurses will give you instructions about calling when your symptoms are severe.
You will be asked to fill out questionnaires during 2 regularly-scheduled clinic visits--at the visit 4-6 weeks after the study begins and at the visit 8-10 weeks after the study begins. These questionnaires measure pain and other symptoms, quality of life, and mood. Completing the questionnaires takes about 1 hour.
If you agree 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.
Your total participation in this study will be up to 10 weeks.
This is an investigational study. Up to 60 patients will take part in this multicenter study. About 10 will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Telephone Intervention, Questionnaires
- Keywords
- Breast Cancer, Pain Intervention, Underserved minority patients, African American, Hispanic, Automated Telephone System for measuring symptoms, Interactive voice response, IVR
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone InterventionBehavioural
Automated Telephone Interactive Voice Response (IVR) system taking approximately 5 minutes, 2 times week for 10 weeks, to rate pain and symptoms.
QuestionnairesBehavioural
Surveys approximately 1 hour each at 2 regularly scheduled clinic visits to rate pain and symptoms. Regardless of group, all symptoms are to be reported.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Intervention | Not described Receives: Behavioral: Telephone Intervention; Behavioral: Questionnaires | |
| Usual Care | Not described Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDASI IVR Patient Symptom Assessment
Measured: Twice weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completion12 Feb 2019
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
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
- Tito Mendoza, PHD, MS, MED, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881010
- Sponsor's protocol ID
- 2005-0380
- Other IDs
- NCI-2012-02119, RSGT-05-219-01-CPPB
- Status last verified
- Apr 2019
- First submitted
- 13 Apr 2009
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Pain Intervention for Underserved Minority Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00881010
- Acronym / sponsor ID
- 2005-0380
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Pain Intervention, Underserved minority patients, African American, Hispanic, Automated Telephone System for measuring symptoms, Interactive voice response, IVR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Feb 2009 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 14 Apr 2009 (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.
The goal of this psychosocial research study is to learn about treating pain and other symptoms of minority patients who have breast cancer. The study will test how well a special telephone system works for improving the pain and symptom management of these patients.
Detailed description
The special telephone system used in this study calls patients on a regular basis and asks them to report their symptoms. The patient's doctor or nurse is notified by a page or e-mail when one or more of these symptoms is severe: pain, shortness of breath, nausea, vomiting, drowsiness, sadness, and emotional distress. Researchers want to find out if using the telephone system is a better way to manage a patient's pain and symptoms than the normal method, in which the doctor and nurse would simply ask about pain and other symptoms.
You will be asked to complete several questionnaires during a visit to the oncology clinic. These questionnaires measure pain and other symptoms, quality of life, and mood. Completing the questionnaires takes about 1 hour. These will be completed during your first study visit (called the "baseline" visit.)
If you choose to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive 1 of 2 treatment plans: telephone intervention or usual care. You have an equal chance of being assigned to either group.
If you are picked to be in the "telephone intervention" group, the research nurse will teach you how to use the telephone system for measuring symptoms. The research nurse also will ask you to practice using the telephone system. The telephone system will call you 2 times a week for 10 weeks and ask you to rate your pain and other symptoms and how much the symptoms interfere with your life. You can set up the most convenient times for the telephone calls. Rating your symptoms using the telephone system takes less than 5 minutes for each call.
Your symptom information from the telephone system will be given to your doctor and nurse at M. D. Anderson. The doctor or nurse will be notified right away by page or e-mail when one or more of these symptoms is severe: pain, shortness of breath, nausea, vomiting, drowsiness, sadness, and emotional distress. Patients in this group will also receive education from the telephone system about pain and pain treatments. If for some reason the telephone system is not working, the research staff will report your severe symptoms to your doctor of nurse, and give you the education about pain and pain treatments.
If you are assigned to the "usual care" group, then you will not be asked to report symptoms using the telephone system, and your symptom information from the questionnaires will not be given to your doctor and nurse at M. D. Anderson.
No matter what group you are assigned to, you will be asked to report all symptoms to your doctor and nurse during your visits to the oncology clinic. You will also be asked to call your doctor or nurse when symptoms are severe. The doctors and nurses will give you instructions about calling when your symptoms are severe.
You will be asked to fill out questionnaires during 2 regularly-scheduled clinic visits--at the visit 4-6 weeks after the study begins and at the visit 8-10 weeks after the study begins. These questionnaires measure pain and other symptoms, quality of life, and mood. Completing the questionnaires takes about 1 hour.
If you agree 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.
Your total participation in this study will be up to 10 weeks.
This is an investigational study. Up to 60 patients will take part in this multicenter study. About 10 will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Intervention | – | Behavioral: Telephone Intervention, Behavioral: Questionnaires |
| Usual Care | – | Behavioral: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Disadvantaged African American or Hispanic females diagnosed with breast cancer aged 18 years or older with access to telephones.
Key inclusion criteria (8 listed)
- Diagnosis of breast cancer
- African American or Hispanic female
- Receiving treatment at LBJ General Hospital, Ben Taub Hospital, or M.D. Anderson Cancer Center
- Socioeconomically disadvantaged, as indicated by hospital billing code
- 18 years of age or older
Key exclusion criteria (3 listed)
- Current diagnosis of psychosis or dementia
- No access to telephones
- Unable to use the IVR system due to physical limitations (e.g., hearing impairment)
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 |
|---|---|---|
| Telephone InterventionAutomated Telephone Interactive Voice Response (IVR) system taking approximately 5 minutes, 2 times week for 10 weeks, to rate pain and symptoms. | Behavioural | Telephone Intervention |
| QuestionnairesSurveys approximately 1 hour each at 2 regularly scheduled clinic visits to rate pain and symptoms. Regardless of group, all symptoms are to be reported. | Behavioural | Telephone Intervention, Usual Care |
Primary outcome
MDASI IVR Patient Symptom Assessment
Time frame: Twice weekly
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 16 Apr 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Tito Mendoza, PHD, MS, MED, BS 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 Breast 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 8 inclusion and 3 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 Apr 2019. 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?
MDASI IVR Patient Symptom Assessment (time frame: Twice weekly). 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 Apr 2019.