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Study Summary
No. 2005-0380:.......Breast......Karen O. Anderson......Symptom Research
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Study Summary Title
Study Summary
Number:
2005-0380
Study Title:Automated Pain Intervention for Underserved Minority Breast Cancer Patients
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Physician New Patient Referral
Name:Karen O. AndersonPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Symptom ResearchReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3470
Contact us about clinical trials
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General Information
Disease Group:BreastSupported By:N/A
Phase of Study:N/AReturn
Visit:
The participants will complete three assessments during regularly scheduled
clinic visits.
Treatment
Agents:
Behavioral InterventionHome Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
None
Description/
Intervention:
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.
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Study Objectives / Outcomes
Primary Objectives:

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.

Secondary Objective:

Objective 3 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.

Hypotheses:
1. Minority breast cancer patients randomly assigned to the IVR intervention group will demonstrate improved pain management and quality of life, as compared to patients in the control group.
2. Minority breast cancer patients randomly assigned to the IVR intervention group will demonstrate reductions in pain-related symptoms (fatigue, sleep disturbance, sadness), as compared to patients in the control group.
3. Minority breast cancer patients in the IVR intervention group will demonstrate improved communication with their physicians, as demonstrated by greater concordance in physician and patient ratings of patients' pain and by improvements in the adequacy of prescribed analgesics and analgesic doses.
4. Minority breast cancer patients in the IVR intervention group will demonstrate reductions in self-reported barriers to optimal pain management, as compared to patients in the control group.
5. The feasibility of the IVR intervention for underserved African American and Hispanic patients will be demonstrated by good rates of patient recruitment and retention, patient adherence to the IVR call schedule, and patient evaluation of the IVR intervention. The feasibility also will be evaluated by provider responses to the IVR alerts and prompts for clinical practice guidelines.

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Study Status Information
Study Activation / Registration Date:10/06/2005
IRB Review and Approval Date:06/15/2005
Study Type:Not Applicable
Recruitment Status:Closed
Projected Accrual:60
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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)

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Links
Registration Number: NCT00881010
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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