Automated Pain Intervention for Underserved Minority Breast Cancer Patients

NCT00881010 | Completed DMC

• 3 other identifiers: 2005-0380NCI-2012-02119RSGT-05-219-01-CPPB
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• MDASI IVR Patient Symptom Assessment

  Twice weekly

Study Arms (2)

Telephone Intervention

Behavioral: Telephone Intervention; Behavioral: Questionnaires

Usual Care

Behavioral: Questionnaires

Interventions

Telephone Intervention BEHAVIORAL

Automated Telephone Interactive Voice Response (IVR) system taking approximately 5 minutes, 2 times week for 10 weeks, to rate pain and symptoms.

Telephone Intervention

Questionnaires BEHAVIORAL

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.

Telephone Intervention; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• Current diagnosis of psychosis or dementia
• No access to telephones
• Unable to use the IVR system due to physical limitations (e.g., hearing impairment)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tito Mendoza, PHD, MS, MED, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 14, 2009
• Study Start: February 1, 2009
• Primary Completion: February 12, 2019
• Study Completion: February 12, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)