Spousal Relationships and Pain in Metastatic Breast Cancer
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Spousal Relationships and Pain in Metastatic Breast Cancer|
- Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Survey + ED
Part 1: Survey + Electronic Diaries (ED)
Part 2: 3 Month, 6 Month Survey + ED
45 minute survey about health, pain and relationshipsBehavioral: Interview
Feedback on use of handheld computer electronic diaries (ED).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00386620
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Hoda Badr, PhD||M.D. Anderson Cancer Center|