Spousal Relationships and Pain in Metastatic Breast Cancer
Completed
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00386620
- Run by
- M.D. Anderson Cancer Center
- People needed
- 548
- Starts
- 2004-10-01
- Last updated by the study team
- 2015-07-07
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- For Patients: Being a female patient diagnosed with metastatic breast cancer.
- For Patients: Initiating treatment for metastatic breast cancer
- For Patients: Having and ECOG Performance Status Score of 2 or less
- For Spouses: Being the male spouse or significant other of a female patient diagnosed with metastatic breast cancer
- For Spouses: Having the patient's consent to be contacted
- For Patients and Spouses: Having the ability to read and speak English well enough to understand the consent form and complete the questionnaires
- For Patients and Spouses: Being able to provide informed consent
You may not qualify if…
- For Patients and Spouses: Not being able to provide informed consent.
- For Patients: Rating average pain as 0 on the BPI
Where it is running
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.