Automated Pain Intervention for Underserved Minority Breast Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Telephone Intervention; Behavioral: Questionnaires

Detailed Description

The special telephone system used in this study calls patients on a regular basis and asks them to report their symptoms. The patient's doctor or nurse is notified by a page or e-mail when one or more of these symptoms is severe: pain, shortness of breath, nausea, vomiting, drowsiness, sadness, and emotional distress. Researchers want to find out if using the telephone system is a better way to manage a patient's pain and symptoms than the normal method, in which the doctor and nurse would simply ask about pain and other symptoms.

You will be asked to complete several questionnaires during a visit to the oncology clinic. These questionnaires measure pain and other symptoms, quality of life, and mood. Completing the questionnaires takes about 1 hour. These will be completed during your first study visit (called the "baseline" visit.)

If you choose to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive 1 of 2 treatment plans: telephone intervention or usual care. You have an equal chance of being assigned to either group.

If you are picked to be in the "telephone intervention" group, the research nurse will teach you how to use the telephone system for measuring symptoms. The research nurse also will ask you to practice using the telephone system. The telephone system will call you 2 times a week for 10 weeks and ask you to rate your pain and other symptoms and how much the symptoms interfere with your life. You can set up the most convenient times for the telephone calls. Rating your symptoms using the telephone system takes less than 5 minutes for each call.

Your symptom information from the telephone system will be given to your doctor and nurse at M. D. Anderson. The doctor or nurse will be notified right away by page or e-mail when one or more of these symptoms is severe: pain, shortness of breath, nausea, vomiting, drowsiness, sadness, and emotional distress. Patients in this group will also receive education from the telephone system about pain and pain treatments. If for some reason the telephone system is not working, the research staff will report your severe symptoms to your doctor of nurse, and give you the education about pain and pain treatments.

If you are assigned to the "usual care" group, then you will not be asked to report symptoms using the telephone system, and your symptom information from the questionnaires will not be given to your doctor and nurse at M. D. Anderson.

No matter what group you are assigned to, you will be asked to report all symptoms to your doctor and nurse during your visits to the oncology clinic. You will also be asked to call your doctor or nurse when symptoms are severe. The doctors and nurses will give you instructions about calling when your symptoms are severe.

You will be asked to fill out questionnaires during 2 regularly-scheduled clinic visits--at the visit 4-6 weeks after the study begins and at the visit 8-10 weeks after the study begins. These questionnaires measure pain and other symptoms, quality of life, and mood. Completing the questionnaires takes about 1 hour.

If you agree to participate in the companion caregiver study, the study staff will use your demographic and clinical data to study the influence of your symptoms on your caregiver's physical and mental health.

Your total participation in this study will be up to 10 weeks.

This is an investigational study. Up to 60 patients will take part in this multicenter study. About 10 will be enrolled at M. D. Anderson.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MDASI IVR Patient Symptom Assessment	Twice weekly

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Tito Mendoza, PHD, MS, MED, BS, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): February 12, 2019
• Study Completion (Actual): February 12, 2019

Study Registration Dates

• First Submitted: April 13, 2009
• First Submitted That Met QC Criteria: April 13, 2009
• First Posted (Estimate): April 14, 2009

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Breast Cancer; African American; Hispanic; Pain Intervention; IVR; Interactive voice response; Underserved minority patients; Automated Telephone System for measuring symptoms
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No