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Automated Pain Intervention for Underserved Minority Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00881010
Recruitment Status : Active, not recruiting
First Posted : April 14, 2009
Last Update Posted : August 25, 2017
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: Telephone Intervention Behavioral: Questionnaires

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Automated Pain Intervention for Underserved Minority Breast Cancer Patients
Actual Study Start Date : February 2009
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
Telephone Intervention Behavioral: Telephone Intervention
Automated Telephone Interactive Voice Response (IVR) system taking approximately 5 minutes, 2 times week for 10 weeks, to rate pain and symptoms.
Behavioral: Questionnaires
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.
Usual Care Behavioral: Questionnaires
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.



Primary Outcome Measures :
  1. MDASI IVR Patient Symptom Assessment [ Time Frame: Twice weekly ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Disadvantaged African American or Hispanic females diagnosed with breast cancer aged 18 years or older with access to telephones.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881010


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
American Cancer Society, Inc.
Investigators
Principal Investigator: Tito Mendoza, PHD, MS, MED, BS M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00881010     History of Changes
Other Study ID Numbers: 2005-0380
NCI-2012-02119 ( Registry Identifier: NCI CTRP )
RSGT-05-219-01-CPPB ( Other Grant/Funding Number: American Cancer Society )
First Posted: April 14, 2009    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Pain Intervention
Underserved minority patients
African American
Hispanic
Automated Telephone System for measuring symptoms
Interactive voice response
IVR

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases