Automated Pain Intervention for Underserved Minority Breast Cancer Patients - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	American Cancer Society
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00881010

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

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 2014 (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.

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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:

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

Exclusion Criteria:

Current diagnosis of psychosis or dementia
No access to telephones
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

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:	March 8, 2012
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 May 23, 2012