Spousal Relationships and Pain in Metastatic Breast Cancer

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Ecological Momentary Assessment (EMA) refers to the collection of repeated measurements of phenomena as they occur in naturalistic settings using hand-held computers. By providing an EMA of psychosocial variables that influence patient pain and pain behaviors, this study seeks to characterize the pain experience in metastatic breast cancer from both patients' and spouses' perspectives.

This study consists of two 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.

The specific aims of this study are to: (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) 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) use ecological momentary assessment to characterize patient pain, spouse response to patient pain, and patient behaviors in response to pain.

Condition or disease	Intervention/treatment
Breast Cancer	Behavioral: Questionnaire; Behavioral: Interview

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	548 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Spousal Relationships and Pain in Metastatic Breast Cancer
Study Start Date :	October 2004
Actual Primary Completion Date :	July 2015

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Survey + ED; Part 1: Survey + Electronic Diaries (ED) Part 2: 3 Month, 6 Month Survey + ED	Behavioral: Questionnaire; 45 minute survey about health, pain and relationships Behavioral: Interview; Feedback on use of handheld computer electronic diaries (ED).

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses. [ Time Frame: 6 Months ]

Secondary Outcome Measures :

1. Pilot of hand-held computers at home for metastatic breast cancer patient and spouses to answer questions about pain and other symptoms. [ Time Frame: 14 Days (Survey Response + 30 Minute Interview) ]

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Women diagnosed with metastatic breast cancer and their male spouse or significant other

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

United States Department of Defense

Investigators

Principal Investigator:	Hoda Badr, PhD	M.D. Anderson Cancer Center

More Information

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00386620 History of Changes
Other Study ID Numbers:	2003-0595; W81XWH-04-1-0425 ( Other Identifier: Department of Defense Breast Cancer Research Program )
First Posted:	October 11, 2006
Last Update Posted:	July 7, 2015
Last Verified:	July 2015

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer; Cancer Control; Spousal Relationships	Questionnaire; Interview; Pain

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases