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Automated Pain Intervention for Underserved Minority Breast Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

Automated Pain Intervention for Underserved Minority Breast Cancer Patients


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.


Inclusion Criteria:



1. Diagnosis of breast cancer

2. African American or Hispanic female

3. Receiving treatment at LBJ General Hospital, Ben Taub Hospital, or M.D. Anderson
Cancer Center

4. Socioeconomically disadvantaged, as indicated by hospital billing code

5. 18 years of age or older

6. Living in the United States

7. Speaks English or Spanish

8. "Pain worst" score of 4 or greater on the Brief Pain Inventory

Exclusion Criteria:

1. Current diagnosis of psychosis or dementia

2. No access to telephones

3. Unable to use the IVR system due to physical limitations (e.g., hearing impairment)

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

MDASI IVR Patient Symptom Assessment

Outcome Time Frame:

Twice weekly

Safety Issue:

No

Principal Investigator

Karen O. Anderson, PHD, MS, BA

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005-0380

NCT ID:

NCT00881010

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Pain Intervention
  • Underserved minority patients
  • African American
  • Hispanic
  • Automated Telephone System for measuring symptoms
  • Interactive voice response
  • IVR
  • Breast Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030