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Automated Pain Intervention for Underserved Minority Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00881010
First received: April 13, 2009
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

Objective 1: To pilot test the efficacy of the interactive voice response (IVR) intervention for improving pain management and quality of life of underserved minority patients with breast cancer, as compared to the current standard of care.

Objective 2: To pilot test the efficacy of the IVR intervention for improving pain-related symptoms (fatigue, sleep disturbance, sadness) of underserved minority patients with breast cancer, as compared to the current standard of care.

Objective 3 (Secondary): To evaluate the feasibility of an IVR intervention for pain management that targets both underserved minority patients with breast cancer and their health care providers.


Condition Intervention
Breast Cancer
 Behavioral: Telephone Intervention
Behavioral: Questionnaires

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Automated Pain Intervention for Underserved Minority Breast Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • MDASI IVR Patient Symptom Assessment [ Time Frame: Twice weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881010

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
American Cancer Society, Inc.
Investigators
Principal Investigator: Karen O. Anderson, PHD, MS, BA UT MD Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00881010     History of Changes
Other Study ID Numbers: 2005-0380
Study First Received: April 13, 2009
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013