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Neuropathic Pain in Survivors of Breast Cancer


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

Thank you

Trial Information

Neuropathic Pain in Survivors of Breast Cancer


You have already been contacted by phone about participating in this study. You have
received study documents (this consent and the study questionnaires) because you said over
the phone that you would like to participate in this study.

In this study you will be asked to complete questionnaires that will ask about any pain you
may be experiencing and about the quality of your life. These questionnaires will also ask
for demographic information (such as age, race, and sex) and about your health. It should
take about 1 hour to complete all of the questionnaires. In addition to the questionnaires,
you will also be asked questions about any medications you may currently be taking for pain.
All of the information you include on the questionnaires will be kept confidential. There
are no right or wrong answers to the questions. A postage-paid return envelope has been
provided for you to return this consent and the questionnaires.

Researchers are interested in how pain is related to certain treatments and medical
conditions. As part of this study, researchers will review your medical records to see what
type of cancer treatment you received and whether you had any pain related to the treatment.
They will also see if you had any non-cancer health conditions that may have affected pain
and quality of life.

This survey is for research purposes only. Your healthcare provider will not be informed of
your responses to this survey. If you are experiencing severe pain and/or other symptoms,
please contact your healthcare provider. The study staff has also included a list of
community resources that you may contact for different types of services.

Your participation in this study will be over once you mail back the consent and
questionnaires.

This is an investigational study. Up to 635 individuals will be asked to take part in this
study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



- Breast cancer patients who were participants in clinical trials (ID98-240; ID94-002)
for taxanes during 1994-2001

- Alive and with current contact information

- Age ≥ 18 years. (This restriction is based on inclusion criteria for the clinical
trials from which subjects will be recruited. All patients will be at least 18 years
or older for this study.)

Exclusion Criteria:

1) None

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To learn about pain among individuals who have been treated for breast cancer with paclitaxel.

Outcome Time Frame:

3 Years

Safety Issue:

No

Principal Investigator

Cielito C. Reyes-Gibby, DrPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0761

NCT ID:

NCT00535067

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Questionnaire
  • Survey
  • Neuropathic Pain
  • Cancer Survivors
  • Quality of Life
  • QOL
  • Breast Neoplasms
  • Neuralgia

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030