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Study Summary
No. 2003-0595:.......Breast; Cancer Control......Hoda Badr......Behavioral Science
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Study Summary Title
Study Summary
Number:		2003-0595
Study Title:Spousal Relationships and Pain in Metastatic Breast Cancer
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Physician New Patient Referral
Name:Hoda BadrPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-5922
Contact us about clinical trials
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General Information
Disease Group:Breast
Cancer Control		Supported By:N/A
Phase of Study:N/AReturn
Visit:		None, other than regularly scheduled clinic appointments.
Treatment
Agents:		NoneHome Care:Participants will be asked to take the EMA home with them and respond to
prompts for two weeks.
In addition, participants may complete the questionnaire packets at home. No
treatment will be provided during this study.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this psychosocial research study is to look at factors that may
affect the pain experience of patients with metastatic breast cancer. In
addition, this study seeks to determine whether women with metastatic breast
cancer and their spouses can use hand-held computers at home to answer
questions about pain and other symptoms.
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Study Objectives / Outcomes
    This study consists of three parts.
    Part 1 involves developing and pilot testing a hand-held computer program designed to assess antecedents, behaviors, and consequences of patient pain, as well as spouse response to pain. Five couples will complete a baseline survey and carry the hand-held computer for two weeks. They will be interviewed for feedback to refine the program.

    Part 2 is a longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses.
    The Optional Procedure for Part 2 involves using electronic diaries (EDs) to measure the cancer pain experience for patients with metastatic breast cancer and their spouses.

    Part 3 is a one-time needs assessment and service preferences questionnaire that will be used to guide future psychosocial interventions that will stem from this research.

    The primary objectives (specific aims) of this study are:
    (1) To examine patient pain, spouse response to patient pain, and patient behaviors in response to pain over the course of 6 months in couples facing metastatic breast cancer.
    (2) To test the biopsychosocial model of chronic pain in breast cancer; expanding it to include the influence of patient psychological functioning, spouse psychological functioning, and relationship functioning, on patient pain, spouse behaviors, and patient behaviors in response to pain.
    (3) To use ecological momentary assessment to characterize patient pain, spouse response to patient pain, and patient behaviors in response to pain.

    The secondary objective of this study is to describe the psychosocial service needs and preferences of metastatic breast cancer patients and their partners.
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Study Status Information
Study Activation / Registration Date:10/13/2004
IRB Review and Approval Date:08/06/2003
Study Type:Therapeutic
Recruitment Status:Open
Projected Accrual:N/A
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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) For Patients: Being a female patient diagnosed with metastatic breast cancer.

2) For Patients: Initiating treatment for metastatic breast cancer

3) For Patients: Having and ECOG Performance Status Score of 2 or less

4) For Spouses: Being the male spouse or significant other of a female patient diagnosed with metastatic breast cancer

5) For Spouses: Having the patient's consent to be contacted

6) For Patients and Spouses: Having the ability to read and speak English well enough to understand the consent form and complete the questionnaires

7) For Patients and Spouses: Being able to provide informed consent
Exclusion Criteria:1) For Patients and Spouses: Not being able to provide informed consent.

2) For Patients: Rating average pain as 0 on the BPI
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Links
Registration Number: NCT00386620
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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