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NCT00386620 · ClinicalTrials.gov registry record
Spousal Relationships and Pain in Metastatic Breast Cancer
A clinical trial, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- 548
- Enrollment target
NCT00386620: Completed study, sponsored by M.D. Anderson Cancer Center.
NCT00386620 is a clinical trial that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 548 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00386620 has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- 548 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Questionnaire
- BEHAVIORAL Interview
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 548 participants |
| Start Date | 2004-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00386620
The ClinicalTrials.gov registry entry for NCT00386620 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 548 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Questionnaire is the first listed.
NCT00386620 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00386620 about?
NCT00386620 is a clinical study titled "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 pa...
What is the current status of trial NCT00386620?
This trial is currently completed. The enrollment target is 548 participants. The study started on 2004-10.
What interventions are being tested in trial NCT00386620?
The interventions under investigation include: Questionnaire (BEHAVIORAL), Interview (BEHAVIORAL).
Who is sponsoring clinical trial NCT00386620?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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