Spousal Relationships and Pain in Metastatic Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00386620 |
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Recruitment Status :
Completed
First Posted : October 11, 2006
Last Update Posted : July 7, 2015
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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 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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). |
- Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses. [ Time Frame: 6 Months ]
- 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) ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- For Patients and Spouses: Not being able to provide informed consent.
- For Patients: Rating average pain as 0 on the BPI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
| 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 Key Record Dates |
| Last Update Posted: | July 7, 2015 |
| Last Verified: | July 2015 |
Keywords provided by M.D. Anderson Cancer Center:
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Breast Cancer Cancer Control Spousal Relationships |
Questionnaire Interview Pain |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |